A PROJECT REPORT ON INDUSTRIAL TRAINING

In partial fulfillment of the requirements for the award of the degree of

BACHELOR OF PHARMACY
Session 2022-23
Dr. A.P.J. Abdul Kalam Technical University, Lucknow

Submitted By
Nitesh Kumar Yadav
2011080500039

R.G.S College of Pharmacy

Lucknow
JUNE, 2022

TRAINING CERTIFICATE
CERTIFICATE
2
This is certified that Mr. Nitesh Kumar Yadav S/O Mr. Sharvan Kumar Yadav, student of RGS
College of Pharmacy, Itaunja, Lucknow. Has been completed industrial training in
UNIBIOTECH FORMULATIONS, SOLAN. At during the period, 28 JAN to 26 FEB, 2023 &
submitted report on Production/Quality Control.
This work is done originally by students under my Supervision.
The industrial training was enriched with the knowledge & Working culture of the respective
company.

Mr. Dr. Bharat Mishra

(Supervisor) (Director)
Unibiotech formulations, RGS College of Pharmacy,
Solan Itaunja, Lucknow

3
 DECLARATION
I hereby declare that the industrial project work embodied in thus entitled, carried out by me under
the super vision of Manager, BIOTECH FORMULATIONS.
I am indebted to my institutional guide, Mr. Ravi Kant Kushwaha, Professor RGS College of
Pharmacy, Itaunja, Lucknow for their step-by-step guidance throughout the preparation of
Industrial training report.

Nitesh Kumar Yadav

2011080500039

4
 ACKNOWLEDGEMENT
I consider it a great privilege &honor to have the opportunity to undergo the industrial training work
in Unibiotech Formulation, I would like to offer my heartiest thanks to Mr. Amit Mishra (Quality
Control Manager, Unibiotech Formulations).
I convey my heartiest thanks to Plant Head, Production Manager, QC Manager, Finished Product
Manager for their most valuable suggestions constant encouragement, and affectionate guidance
during the period of this training.
I would like to thank all trainees and staffs, who help me very much and without whom support and
guidance it was impossible for me to complete the project successfully.
I owe deep gratitude to the Manager and Sales Market for their support and guide to carryout the
tasks assigned to us while we are in the training. At last, I am greatly thankful to all my seniors and
colleagues in Unibiotech Formulations for extending their constant cooperation which went a long
way towards the completion of this Training and Report.
I consider it my to convey me deep sense of gratitude and pay respectful regards towards Dr.
Bharat Mishra (Director) of RGS college of Pharmacy for valuable guidance, consistence
encouragement and pleasant discussion throughout.
My special thanks to Mr. Ravi kant Kushwaha (Professor RGS College of Pharmacy), who
advised me to join this Pharmaceutical Industry for better experience and knowledge.

Nitesh Kumar Yadav

B. Pharm. 3rd year (6th semester)
2011080500039
RGS College of Pharmacy,
Itaunja, Lucknow.

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 PREFACE
Pharmacy is a profession which is concerned with the art and science of preparing suitable
and convenient material for distribution and use in the treatment and prevention of disease, so it is a
fully technical profession where practical knowledge is much more important along with theoretical
knowledge.
According to curriculum of a four-year integrated degree course of BACHELOR OF PHARMACY
each student has to undergo practical training for a period of one month in any of the
pharmaceutical industry in India.
I was directed to undergo at "Unibiotech Formulations." and this report contains a brief
description of the above pharmaceutical industry which was observed during the training program.

6
LAYOUT

Figure 1 Layout

7
CONTENTS

8
 COMPANY PROFILE

UNIBIOTECH FORMULATION, Solan.

Unibiotech Formulations is a national level renowned pharmaceutical organization having
corporate office located in the City Beautiful – Chandigarh. It is one of the most reputed
pharmaceutical companies launched in the year 2004. Today, the company has created a
strong base in its area of operations with marketing team of around 400 field personnel,
spread all over the country. Unibiotech Formulations provides innovative & Quality
formulations at affordable prices to our customers and believes in building long lasting
relationship with strong & close-knit family of business associates, who provide our range
of products to millions of people across the country and enable our organization to scale
newer heights of professional excellence year after year.

Figure 2Unibiotech formulation Company

Unibiotech Formulations has sophisticated manufacturing facility with two manufacturing

units which meet C-GMP / WHO Standards. All our products are manufactured in
compliance with the latest regulatory guidelines. Our superior quality of products has
enabled us to earn a remarkable market reputation and helped us to attain many reputed
clients throughout India. We are also proud to be an ISO 9001-2008 certified company.
Under the able guidance of our mentor, Mr. M. S Bhatia, we have carved a niche in this
sector. His vast industry experience and sharp business acumen have been guiding factors
in attaining remarkable growth and development.

9
Unibiotech Formulations manufactures wide assortment of more than 400 pharmaceutical
products that help in curing various diseases and improving immunity of the body. We use best
Quality API’s; thus, our range is highly effective and safe in use. We also specialize in producing a

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 LIST OF ABBRIVATION
AC Anticaking agent CTG Component or coating GMO Genetically Modified
for fruits & vegetables Organism
ADI Accepted Daily Intake
D&C Dyes & Cosmetics GMP Good Manufacturing
AF Antifoaming agent Practice
DMF Drug Master File
ANDA Abridged New Drug GRAS Generally Regarded
Application DMPK Drug Metabolism As Safe
and Pharmacokinetics
AOX Antioxidant HERB Herbicide
DS Degree of Substitution
API Active Pharmaceutical HFC Hydrofluorocarbon
Ingredient DS Dietary supplement
HLB Hydrophilic-Lipophilic
Art Artificial EMUL Emulsifier Balance

B&N Buffer and neutralizing ENZ Enzyme HOR Hormone

agent
EP European Pharmacopoeia ICH International
BCS Biopharmaceutical Conference on
Classification System ESO Essential oil and/or Harmonization
oleoresin (solvent free)
BL Bleaching agent or flour- IIG Inactive Ingredients
maturing agent FAO Food and Agricultural (Database)
Organisation
BRP Biological Reference IM Intramuscular
Preparation FCC Food Chemicals Codex
INCHI International
bw Body Weight FDA Food and Drug Chemical Identifier
Administration
CAS No. Chemical Abstracts INCI International
Service Number FL/ADJ Substance used in Nomenclature of Cosmetic
conjunction with flavours Ingredients
CfuColony Forming Unit
FLAV Natural flavouring InclIncluding
CLP Classification, agent
Labelling and Packaging INH Inhibitor
FUM Fumigant
CoA Certificate of Analysis INN International Non-
FUNG Fungicide proprietary Name
COC Certificate of
Conformance GCP Good Clinical Practice IP Indian Pharmacopoeia

cP Centipoise GDP Good Distribution ISO International

Practice Organisation for
CRS Chemical Reference Standardization
Substance GHS Globally Harmonized
System IU International Unit
CTD Common Technical
Document IV Intravenous

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JP Japanese Pharmacopoeia NUTR Nutrient SOLV Solvent

LD Lethal dose NUTRS Nutritive Sweetener SP/ADJ Spray adjuvant

LOA Letter of Access PSUR Periodic Safety Spec Specifications

Update Report
LOD Loss in Drying SPF Specified-Pathogen Free
QA Quality Assurance
MAA Marketing STAB Stabilizer
Authorization Application QbD Quality by Design
Suppl Supplement
MAH Marketing QC Quality Control
Authorization Holder SY/FL Synthetic flavour
QP Qualified Person
MfrManufacturer TPN Total Parenteral
R Reagent Nutrition
MIC Minimum Inhibitory
Concentration R&D Research and TWA Time Weighted
Development Average
MISC Miscellaneous
RDA Recommended Daily UNII Unique Ingredient
Mn Molecular Number Allowance Identifier

NCE New Chemical Entity Res Residue USAN United States

Adopted Name
NDA New Drug Application SANI Sanitizing agent for
food processing equipment UV Ultraviolet
NF National Formulary
SDA Solubilizing and v/v Volume in Volume
NIR Near Infrared dispersing agent
VET Veterinary drug
NMT Not More Than SDS Safety Data Sheet
W/O/W Water-in-oil-in
NNS Non-nutritive SEM Scanning Electron Water
sweetener Micrograph
w/w Weight in Weight
nonStdzd non-standardized SEQ Sequestrant

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 TABLET SECTION
Tablet
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or
compacted into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure
efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners
or flavours to mask the taste of bad-tasting active ingredients; and pigments to make uncoated
tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to
make the tablet smoother and easier to swallow, and to make it more resistant to the environment,
extending its shelf life.

Advantage
 Production aspect
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stability
 User aspect (doctor, pharmacist, patient)
 Easy to handling.
 Lightest and most compact.
 Greatest dose precision & least content variability.
 Coating can mark unpleasant tastes & improve pt. acceptability.

Disadvantages
 Some drugs resist compression into dense compacts.
 Drugs with poor wetting, slow dissolution, intermediate to large dosages may be difficult or
impossible to formulate and manufacture as a tablet that provide adequate or full drug
bioavailability.
 Bitter taste drugs, drugs with an objectionable odour, or sensitive to oxygen or moisture may
require encapsulation or entrapment prior to compression or the tablets may require coating.

Types of tablets
1. Route of administration
a) Oral tablets,
b) Sublingual or buccal tablets,
c) Vaginal tablets,
2. Production process
1. Compressed tablets,
2. Multiple compressed tablets,
 Tablet within a tablet: core and shell,
 Multilayer tablet Sugar coated tablets,
 Protect tablets from moisture,
 Mask odour and flavour,
 Elegance,
 Film coated tablets,
 Thin film coat,
 Soluble or insoluble polymer film,
3. Chewable tablets

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  Rapid disintegrate,
 Antacid, rapid action,
 Children drug,
4. Effervescent tablets
 Dissolve in the water before drink,

Ingredients used in tablet formulations

1. Drugs.
2. Fillers, diluents, bulking agent
 To make a reasonably sized tablet.
3. Binders
 To bind powders together in the wet granulation process.
 To bind granule together during compression.
4. Disintegrates
 To promote breakup of the tablets.
 To promote rapid release of the drug.
5. Lubricants
 To reduce the friction during tablet ejection between the walls of the tablet and
the walls of the die cavity.
6. Glidants
 Reducing friction between the particles.
 To improve the flow properties of the granulations.
7. Anti adherents
 To prevent adherence of the granules to the punch faces and dies.

8. Dissolution (enhancers and retardants)

9. Wetting agents
10. Antioxidants
11. Preservatives
12. Colouring agents
13. Flavouring agents
Direct Compression Fillers
 Common material that has been modified in the chemical manufacturing
process to improve fluidity and compressibility,
1) Soluble Fillers
a) Lactose
i) Spray dried lactose
 Lactose is placed in aqueous solution, removed impurities and sprays dried.
 Mixture of large alpha monohydrate crystals and spherical aggregates of smaller
crystals.
 Good flowability but less compressibility.
 Poor dilution potential.
 Loss compressibility upon initial compaction.
 Problem of browning due to contamination of 5-hydroxyfurfural which was accelerated
in the presence of basic amine drugs and catalysed by tartrate, citrate and acetate ions.
ii) Fast-Flo lactose (early 1970s)
 Spherical aggregates of microcrystal’s lactose monohydrate.
 Held together by a higher concentration of glass (amorphous lactose).
 Much more compressible.
 Highly fluid.
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  Non hygroscopic.
 Tablets are three to four times harder than regular spray dried.
iii) Tabletose: agglomerate form of lactose
 More compressible than spray dried but less compressible than Fast Flo lactose.
iv) Anhydrous lactose: free flowing crystalline lactose
 Produced by crystallization above 93C which produces the beta form.
 Pass through steam heated rollers,
 Good flow property, contained high amount of fines, its fluidity is less than optimal.
 Can me reworked.
 At high RH anhydrous lactose will pick up moisture forming the hydrate compound →
increase in the size of tablet if the excipients make up a large portion of the total
weight.
 Excellent dissolution property.

b) Sucrose
i. Di-Pac: co-crystallization of 97% sucrose and 3% modified dextrin
 Small sucrose crystal glued together by dextrin.
 Good flow properties and needs a Glidants only when atmospheric moisture levels are
high (>50%RH).
 Excellent colour stability on aging.
 Concentration of moisture is extremely critical in terms of products compressibility.
 Compressibility increases rapidly in a moisture range of 0.3-0.4%, plateaus at a level of
0.4-0.5% and rises again rapidly up to 0.8% when the product begins to cake and lose
fluidity.
 Dilution potential 20-35%.
 Tablet tend to harden slightly during the first hours after compression or when aged at
high humidity’s and then dried (this is typical of most direct compression sucrose’s or
dextrose’s).
ii. Nutab: 95.8% sucrose, 4% convert sugar
 Equimolecular mixture of laevulose and dextrose and 0.1 to 0.2% each of corn-starch
and magnesium striate.
 Large particle size distribution and good fluidity.
 Poor colour stability.
c) Dextrose
i. Emdex: spray crystallized
 90-92% dextrose, 3-5% maltose and the remainder higher glucose polysaccharides.
 Available both anhydrous and a hydrate product.
 Excellent compressibility.
 Largest particle size, blending problems may occur.
d) Sorbitol
 Exists in a number of polymorphic crystalline forms and amorphous form.
 Widely used in sugar-free mints and as a vehicle in chewable tablets.
 Forms a hard compact.
 Hygroscopic and will clump in feed frame and stick to the surfaces of the die table
when tableted at humidity’s >50%.
 Lubricant requirements increase when the MC of the Sorbitol drops below 0.5% or
exceeds 2%.
e) Mannitol
 Exists in a number of polymorphic forms.
 Not make as hard a tablet as Sorbitol.
 Less sensitive to humidity.
 Widely used where rapid and complete solubility is required.
 Use as a filler in chewable tablets.
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  Cool mouth feels but expensive.
f) Maltodextrin
i. Maltrin
 Highly compressible.
 Completely soluble.
 Very low hygroscopic.
2) Insoluble fillers
a) Starch
i. Starch 1500:intact starch grains and ruptured starch grains that have been partially
hydrolysed and subsequently agglomerate.
 Extremely high MC (12-13%).
 Does not form hard compacts.
 Dilution potential is minimal.
 Not generally used as filler-binder but as filler disintegrates.
 Retains the disintegrates properties of starch without increasing the fluidity and
compressibility of the total formulation.
 Deforms elastically when a compression force is applied, it imparts little strength to
compacts.
 Lubricants tends to dramatically soften tablets containing high concentration of
Starch 1500.
 Spray dried starch.
ii. Era-Tab: Spray-dried rice starch
 good fluidity.
 MC 10-13%.
 Compressibility depends on moisture.
 Rework ability.
 Low bulk density.
b) Cellulose
i. Microcrystalline cellulose (Avicel)
 The most important tablet excipients developed in modern times.
 Derived from a special grade of purified alpha wood cellulose by severe acid
hydrolysis to remove the amorphous cellulose portions, yielding particles consisting
of bundles of needle like microcrystals.
 PH102 more agglomerated, larger particle size, slightly better fluidity but not
significant decrease in compressibility.
 Most compressible.
 Highest dilution potential.
 A strong compact is formed due to the extremely large number of clean surfaces
brought in contact during the plastic deformation and the strength of the hydrogen
bonds formed.
 Extremely low coefficient of friction, no lubricant requirement.
 When more than 20% of drugs or other excipients are added, lubrication is necessary.
 Not used as the only filler because of its cost and density.
 Usually used in the concentration of 10-25% as a filler-binder-disintegrates, rapid
passage of water into the compact and the instantaneous rupture of hydrogen bonds.
 Fluidity is poor because of its relatively small particle size, small amount of Glidants
is recommended in the formulations containing high concentration of MHC.
 Tablets are softening on exposure to high humidity’s.
 This softening is reversible when tablets are removed from the humid environment.
 More than 80% MCC may slow the dissolution rates of AI having low water
solubility.
 Small particles get physically trapped between the deformed MCC particles, which
delays wetting and dissolution.
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  This phenomenon can be overcome by adding portions of water-soluble excipients.
c) Inorganic Calcium Salts
i. Dicalcium phosphate (Emcompress or DiTab)
 Free flowing aggregates of small microcrystal’s that shatter upon compaction.
 Inexpensive and possesses a high degree of physical and chemical stability.
 No hygroscopic at RH of up to 80%.
 Good fluidity.
 Slightly alkaline with a pH of 7.0 to 7.3.
 Precludes its use with AI that is sensitive to even minimal amounts of alkalinity.
ii. Tricalcium Phosphate (TriTab)
 Less compressible and less soluble, higher ratio of calcium ions.
Essential Properties of Tablet
 Accurate doses of medicament, uniform in weight, appearance and diameter.
 Have the strength to withstand the rigors of mechanical shocks encountered in its
production, packaging, shipping and dispensing.
 Release the medicinal agents in the body in a predictable and reproducible manner.
 Elegant product, acceptable size and shape.
 Chemical and Physical stabilities.

TABLET PRODUCTION
Powder intended for compression into tablets must possess two essential properties-
 Powder Fluidity
 The material can be transported through the hopper into the die.
 To produce tablet of a consistent weight.
 Powder flow can be improved mechanically by the use of vibrators, incorporate the
Glidants.
 Powder Compressibility
 The property of forming a stable, intact compact mass when pressure is applied.
Tabletting Methods (granulation)
 Dry Methods
a) Direct Compression
b) Dry Granulation
 Wet Methods
a) Wet Granulation
1. Direct Compression: -

Example: NaCl. NaBr, KCl

17
  Tablet are compressed directly from powder blends of the active ingredients and
suitable excipients.
 No pre-treatment of the powder blends by we or dry granulation procedure is
necessary.
Advantages
1. Economy
 Machine: fewer manufacturing steps and pieces of equipment.
 Labour: reduce labour costs.
 Less process validation.
 Lower consumption of power.
2. Elimination of Granulation Process
 Heat (wet granulation)
 Moisture (wet granulation)
 High Pressure (dry granulation)
Processing without the need for moisture and heat which is inherent in most wet granulation
procedures.
Avoidance of high compaction pressure involves in producing tablets by slugging rolls compaction.
Elimination of variabilities in wet granulation processing.
3. Binders (temp, viscous, age)
 Viscosity of the granulating solution (depend on its temperature).
 Rateofbinderadditionandkneadingcanaffectthepropertiesofthegranulesformed.
 The granulating solution, the type and length of mixing and the method and rate of
wet and dryscreening can change the density and particle size of the granules, which
can have a major effect onfillweight andcompaction qualities.
4. Type and rate of drying
 Can lead not only to critical changes in equilibrium MC but also to un-
blending as soluble activeingredientsmigrateto thesurfaces ofthedrying
granules.
 Moreunitprocessesareincorporatedinproduction;thechancesofbatch-to-batch
variationarecompounded.
5. Prime particle dissociation
 Eachprimarydrugparticleisliberatedfromthetabletmassandisavailable fordissolution.
 Disintegraterapidlytotheprimaryparticlestate.
6. Uniformity of particle size
7. Greater stability of tablet on aging
 Colour.
 Dissolutionrate.
Fewerchemicalstabilityproblemswouldbeencounteredascomparedtothosemadebythewetgranul
ationprocess.
8. concerns
 Excipientsavailablefromonlyonesupplierandoftencostmorethanfillerusedingranulation.
 Procedureconservation,Machineinvestments, Lackofmaterialknowledge.
 Physicallimitationofdrug-Nocompressibility,Noflowability.
 Physicalcharacteristicsofmaterials(bothdrugandexcipients).
 Sizeandsizedistribution-Moisture,Shapeandsurface, Flowability,Density.
 Lottolotvariability,dustingproblem,Colouring.

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2. Wet Granulation: -
Wet granulation is a process of using a liquid binder oradhesive to thepowder mixture. The
amount ofliquid can be properly managed, and over wetting will cause the granules to be too
hard and under
wettingwillcausethegranulestobetoosoftandfriable.Aqueoussolutionshavetheadvantageofbeingsaf
ertodealwith than solvents.

3. Dry Granulation: -

This process is usedwhen the product needed to be granulated may be sensitive to moisture
andheat.Dry granulation can be conducted on a press using slugging tooling or on a roller
compactor commonlyreferred to as a chilsonator. Dry granulation equipment offers a wide range
of pressure and roll types toattain proper densification. However, the process may require
repeated compaction steps to attain theproper granuleendpoint.
Alsocalled as“Pre-compression”or“Slugging”method.
Example: - Aspirin, Vitamin.

Importance of granulation

1. To impart good flow properties to the material,

2. To increase the apparent density of the powders,
3. To change the particle size distribution,
4. Uniform dispersion of active ingredient.

Blending
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Powderstobeusedforencapsulationortobegranulatedmustbewellblendedtoensuregooddrugdistribut
ion.
Inadequateblendingatthisstagecouldresultindiscreteportionofthebatchbeingeitherhighorlowinpote
ncy.
Stepsshouldalsobetakentoensurethatalltheingredientsarefreeoflumpsandagglomerates.
For these reasons,screening and/ormilling of the ingredientsusually makesthe processmore
reliable andreproducible.

Equipment used for Blending

 V- Blender
 Double Cone Blender
 Ribbon Blender
 Slant Cone Blender

Scale up considerations
 Time of blending.
 Blender Loading.
 Size Of Blender.
Sieving
Separationofamixtureofvarious-
sizedparticles,eitherdryorsuspendedinaliquid,intotwoormoreportions,bypassingthrough screens
ofspecifiedmesh sizes.

Importance of Sieving
The sieving process gives three fractions of granules:

 Verycoarse granules,whichreturnbacktothemillingprocess.
 Veryfinefraction,whichreturnbacktothecompaction.
 Fractionwithoptimaldimensionsforfollowingmanufacturingsteps.
Equipment used for Sieving
Specifications:
Model Capacity Power
Sifter-20 100-120Kg. /Hrs. 1.0HP
Sifter-30 150-180Kg. /Hrs. 2.0HP

Dryer
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Inthepharmaceuticalsectorthefallowingdryersareuse:
1. Static Oven,
2. Rotatory Drier,
3. Fluidized Bed Drier,
4. Vacuum Oven,
5. Microwave Drier,
6. Spray Drier,
7. Rotary Atomizer,
8. LR Drier

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22
 TABLET PUNCHING
A tabletpress isa mechanicaldevice thatcompresses powder into tablets of uniformsize
andweight.Apress can be used to manufacture tablets of a wide variety of materials, including
pharmaceuticals, illicitdrugs, cleaning products, and cosmetics. To form a tablet, the granulated
material must be metered into acavity formed by two punches and a die, and then the punches must
be pressed together with great force tofusethematerial together.
Tableting Procedure

 Filling,

 Compression,

 Ejection.
Tablet Compression Machines

 Hopperforholdingandfeedinggranulationtobecompressed.

 Diesthatdefinethesize and shapeofthetablet.

 Punchesforcompressingthegranulationwithinthedies.

 Camtracksfor guidingthemovementofthepunches.

 Feedingmechanismsformovinggranulationfromthehopperintothedies.
Single Punch Machine

 Thecompression isappliedbytheupperpunch.

 Stampingpress.

Multi-station rotary presses: The rotary press has more than one set of tooling: -
 Thediesandthe correspondingpairsofpunchesarearrangedaroundacircularrotatingturret.
 Each individual die with lower punch in its lowest position, passes under the powder
bed which iscontainedwithin afeed frame,which in turn isfed from ahopper.
 The die is completely filled under gravity, flow sometimes being assisted by rotating
fingers in thefeedframe.
 Thequantityofsolid inthedieisadjustedbyweight controllingcam.
 These punches then pass upper pun chtodes cendand the lower pun chtorise.
 Thetoppunchthenwithdrawsandthelowerpunchascendsasitpassesoverandejectioncam.
 Thus, the powder is actively compressed from both top and bottom faces.

23
 TABLET COATING
The coating in the tablet, which is additional step in the manufacturing process.
Objective:
 To mask the taste, odour, or colour of the drug.
 To provide physical and chemical protection for the drug.
 To control the release of the drug from the tablet.
 To protect the drug from the gastric environment of the stomach with an acid resistance
enteric coating.
Types of coating

1. Film Coating
2. Sugar Coating
3. Press Coating.
4. Functional Coatings
a) Enteric Coating
b) Controlled release coating
Sugar Coating

 Traditionally sugar coatings formed the bulk of coated tablets but today film coatings
are the moremoderntechnologyin tablet coating.
 Descriptionoftablets:Smooth,roundedandpolishedtoahigh gloss.
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  Process:Multistageprocessinvolving6separate operations.

Multi-Stage Process

1. Sealing tablet core- application of a water impermeable polymer such as Shellac,

cellulose acetatephthalate and polyvinyl acetate phthalate, which protects the core from
moisture, increasing itsshelflife.
2. Sub coating -by adding bulking agents such as calcium carbonate or talc in
combination withsucrosesolution.
3. Smoothingprocess-removeroughlayersformedinstep2withtheapplicationofsucrosesyrup.
4. Colouring-foraestheticpurposesoftentitanium-based pigmentsareincluded.
5. Polishing - effectively polished to give characteristic shine, commonly using beeswax,
carnaubawax.
6. Printing-indelibleinkforcharacterisation.

Tablet Appearance

 Roundedwithhighdegreeofpolish.
 Largerweightincreases30-50%duetocoatingmaterial.
 Logoor‘breaklines’are possible.
Process

 Difficulttoautomatede.g.,traditionalcoatingpan.
 Considerabletrainingoperationrequired.
 Multistageprocess.
 Notabletobeusedforcontrolledreleaseapartfromentericcoating.

Example of Sugar-Coated Tablets

Simplified Representation of Sugar-coating process-

Film Coating

 Modern approach to coating tablets, capsules, or pellets bysurrounding them with a

thin layer ofpolymericmaterial.
 Descriptionoftablets:Shapedictatedbycontouroforiginalcore.
 Process:Singlestageprocess,whichinvolvessprayingacoatingsolutioncontainingthefollowing:
i.

Polymer.
ii. Solvent.
iii. Plasticizer.
iv. Colorant

25
Thesolutionissprayedontoarotatingtabletbedfollowedbydrying,whichfacilitatestheremovaloftheso
lventleavingbehindthedeposition ofthin film ofcoatingmaterialsaroundeach tablet.
Advantages
Produce tablets in a single step process in relatively short period of time. Process enables
functional coatingstobeincorporated into thedosageform.
Disadvantages
Thereare environmentalandsafetyimplicationsofusingorganicsolventsaswellastheirfinancialexpense.
Tablet Appearance

 Retainsshapeoforiginal core.
 Smallweightincreaseof 2-3%duetocoatingmaterial.
 Logoor ‘breaklines’possible.
Process

 Canbeautomatede.g., AccelaCota.
 Easytrainingoperation.
 Singlestageprocess.
 Easilyadaptableforcontrolledreleaseallowsforfunctionalcoatings.
Coating Material
a) Polymer used in film coating
 Cellulosederivatives.
 Methacrylateaminoestercopolymers.
b) Plasticizer used in film coating
 Polyols- Polyethylene
glycol 400
 Organicesters-diethylphthalate.
 Oils/glycerides-fractionalcoconutoil.
c) Colourants used in film coating
 Ironoxidepigments.
 Titaniumdioxide.

 Aluminumlakes

Water insoluble pigments are more favourable than water soluble colours for the following
reasons:

 Better chemically stability in light.

 Optimised impermeably to water vapour.
 Better opacity.
 Better covering ability.

Press Coating
Presscoatingprocessinvolvescompactionofcoatingmaterialaroundapreformedcore.Thetechniquedi
ffersfrom sugarandfilm coatingprocess.
Advantages

26
Thiscoatingprocessenablesincompatiblematerialstobeformulatedtogether,suchthatonechemicalor
moreis placed in thecoreandtheother(s)in thecoatingmaterial.
Disadvantages
Formulationandprocessingofthecoatinglayerrequiressomecareandrelativecomplexitiesofthemechanismused in
thecompressing equipment.

Functional Coating

Functional coatings are coatings, which perform a pharmaceutical function.

Theseinclude;
a) Entericcoating-
 ThepHstatusofenteric coatedpolymersinthestomach
 Theidealpropertiesofentericcoatedmaterial
b) Controlledreleasecoating
Enteric Coating
The technique involved in enteric coating is protection of the tablet core from disintegration in
the acidicenvironment of the stomach by employing pH sensitive polymer, which swell or
soluble in response to anincreaseinpHto releasethedrug.
Aims of Enteric Protection:

 Tomasktasteorodour.
 Protectionofactiveingredients,fromtheacidicenvironmentofthestomach.
 Protectionfromlocalirritationofthestomachmucosa.
 Releaseofactiveingredientinspecifictargetareawithingastrointestinaltract.
Examples of enteric coated OTC products

 Enteric coated Aspirin

The pH status of enteric coated polymers in the stomach
ThepolymersusedforentericcoatingsremainunionizeatlowpH,andthereforeremaininsoluble.Asthep
H increases in the gastrointestinal tract the acidic functional groups are capable of ionization,
and thepolymerswells orbecomes solublein theintestinal fluid.

Thus, an enteric polymeric film coating allows the coated solid to pass intact through the
stomach to thesmall intestine, where the drug is then released for absorption through the
intestinal mucosa into the humanbodywhereit can exert its pharmacologiceffects.
The ideal properties of enteric coated material

 Permeabletointestinalfluid.
 Compatibilitywithcoatingsolutionanddrug.
 Formationofcontinuous film.
 Nontoxic.
 Cheapandeaseof application.
 Abilitytobe readilyprinted.
27
  Resistancetogastricfluids.

Summary of Polymers used in pharmaceutical formulation as coating materials: -

Polymer Tradename Application

Shellac EmCoat120N  EntericCoatings

 Taste/OdorMasking
Marcoat125

Celluloseacetate Aquacoat  EntericCoatings

 Tastemasking
CPD®Sepifilm  Sustainedreleasecoating
™ 
LPKlucel®Aqua Subcoatmoistureandba
rrier sealant
coat®
pelletcoating
ECDMetolose®
Polyvinyl acetatephthalate Sureteric®  EntericCoatings

Methacrylate Eudragit®  EntericCoatings


SustainedRelease
Coatings
 TasteMasking
 Moistureprotection
 Rapidly
disintegratingFilms

Polymer Dissolution
Factors affecting the release of a drug from a polymer:

 Thickness of the coating material,

 pH,
 Other excipients,
 Ionic state
Thickness of the coating material

 To achieve enteric protection of the core 3-4 mg/cm 2 of the polymer is required to be
applied to thedosageform.
 Methacrylic acid copolymers require a lower amount of polymer compared to cellulose
derivativeswhichusuallyrequirehigheramountsofpolymertoachievethesamecore
protectionastheformer.
 Themorepolymerlayersthatareappliedthe greatertherateofdissolutionofthedrug.

pH

 Dissolutionofpolymersintendedforenterictargetingisdependentuponthedissolutionmedium.Th
isisinfluencedbythe compositionofthepolymer, the monomers, orthetypeand
degreeofsubstitution.

28
 Ionic state

 The rate of polymer dissolution is dependent upon the type of ions present in
the dissolutionmedium.
 Itwasshownthatsodiumchloridepreventeddissolutionofsomepolymers.
Other Excipients

 Influencethedissolutionofpolymer.
 Plasticizers may decrease or increase dissolution rate, depending on the nature of
the plasticizer,whetherit is lipophilicorhydrophilic.
Coating Problems
1. Picking/ Chipping
2. Roughness
3. Sticking
4. Film cracking/ peeling
Coating Equipment
 Standard Coating Pans (Accela Coat)
 Perforated coating Pan
 Fluidized (air suspension) coater.
Accela Coat
Some Common problems in tableting
1. Weight fluctuation

REASON REMEDY

Unsuitablegranulesize Changethegranulesize;usuallysmallgranulesareforsmall
ertablets.
Granuleshape Prepareasroundgranulesaspossibletoavoidunevenairspa
ces.
Powdercontent Theproportionofthefinepowdershouldbekeptbelow20%
ofgranulate.
Volumedifferential Thefillingvolumeinthedieshouldbenearaspossibletothelo
osevolumedensity.
FlowControl Lubricants-
Choiceandquantitymaybechangedtocontroltheflowofgr
anulesusually1-5%aresufficient.
Electrostaticcharging Thiscanbeeliminatedbysprayingthegranuleswithwateri
nordertoincreasetheirconductivitysothattheelectricityis
conductedt0thesurroundingmachinepartsandearthed.

Humidity IfthegranulateistoowetRe-drythegranules.

2. Double feed

29
 Doublefeedmayoccurwhentabletsadheretothepunchesoriftheyarenotproperlyejectedduetoinco
rrectdueto incorrectsettingofejectors checkthesettingofejectors.
3. Mottling
Mottling is an unequal distribution of color on a tablet, with light or dark areas standing an
otherwiseuniform surface. One cause of mottling is a drug whose color differs from the tablet
excipients or a drugwhosedegradationproductsarecolored. Theuseofcolorantsmaysolvethe
aboveproblem.
4. Capping
Incappingthetoporbottom partofthetabletseparatesfrom themainbodycompletelyarepartially.
5. Sticking
Adherenceofgranulesto diewallsisreferredtoas‘sticking’.

Excessivehumidity Drythegranulesandorairconditiontheroom.

Lowmeltingpointofindividualingredient Separatelygranulatesuchingredients.

Insufficientcohesion Slowlyraisethecompressionpressure

Excesspowders Siftoutexcesspowders

Insufficientlubrication Increaseorchangethelubricant

Diesandpunchesdull Polishthediesandpunches.

Defectiveengravingdesign Useroundededges.

Evaluation of tablets: -
1. Appearance,
2. Contentofactiveingredientinthetablets,
3. Uniformityofweight,
4. Sizeandshape,
5. Organolepticproperties,
6. Uniformitycontent,
7. Hardness andfriabilitytest,
8. Disintegrationtest,
9. Dissolution,

UNIBIOTECH Formulation PRODUCT LIST (TABLETS)

S.N. Tablets

1 Cefpodoxime 200mg

2 Ofloxacin 200mg, Ornidazole 500mg

3 Cefixime 200mg, Lactic acid Bacillus

30
 4 Cefixime 200mg Dispersible Tablets

5 Azithromycin 250mg

6 Azithromycin 500mg

7 Amoxicillin 500mg, Clavulanic Acid 125mg

8 Amoxicillin 500mg, Clavulanic Acid 125mg

9 Cefpodoxime 200mg, Clavulanic Acid 125mg

10 Ascorbic Acid 100mg, Ascorbic Acid 400mg

11 Enzyme Tablet

12 Kidney Stone Crusher

13 Ofloxacin 200 mg + Cefixime 200 mg tablet

14 Deflazacort -6 mg

15 Deflazacort - 30 mg

CAPSULE SECTION
Capsule

31
Capsule is solid dosage forms in which one or more medicinal and or inert substances are
enclosed within
asmallshellorcontainergenerallypreparedfromasuitableformofgelatin.Dependingupontheirformula
tion,thegelatin capsuleshells maybehard orsoft.

Characteristics: -
1. Maybeswallowedwholebythepatient.
2. Maybeinsertedinto therectum fordrugreleaseand absorptionfrom thesite.
3. Thecontentsmaybe removed fromthe gelatine
shellandemployedasapremeasuredmedicinalpowder,thecapsuleshellbeinguseto contain
adoseofthemedicinal substance.
4. Elegance.
5. Easeofuse.
6. Portability.
7. Tastelessshelltomasktheunpleasanttaste/odourofthedrug.
8. Permitsphysiciantoprescribetheexactmedicationneededbythepatient.
9. Convenientlycarried.
10. Readilyidentified.
11.Easilytaken.
12. Tastelesswhenswallowed.
13.Commonlyembossedorimprintedontheirsurfacethe

manufacturer’snameandproductcodereadilyidentified.
14.
Components of Capsules: -
1. Gelatine.
2. FD &C andD &Ccolorant.
3. Sugar.
4. Water-12to 16 % but mayvarydependingon thestoragecondition.
5. Sulphurdioxide(.15%)-preventdecomposition duringmanufacture.
6. Opaquants/Opacifyingagent-titaniumdioxide.

Types of Capsules: -
The two main of capsules are-
1. Soft Gelatine or Soft Gel Capsule
2. Hard Gelatine Capsule

SOFT GEL ENCAPSULATION

In 1834, Mothes and Dublanc were granted a patent for a method to produce a single-piece gelatin
capsulethat was sealed with a drop of gelatin solution. They used individual iron molds for their process,
filling thecapsules individually with a medicine dropper. Later on, methods were developed that used sets
32
of plateswith pockets to form the capsules. Although some companies still use this method, the equipment
is notproduced commercially any more. All modern soft-gel encapsulation uses variations of a process
developedby R.P. Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with
the fillingtakingplacebyblowmolding.

This method reduced wast age, and was the first process toyield capsules with highly repeatable dosage.

HARD GELATIN CAPSULES

Figure 3 Hard Gelatin Capsule

Two-parthard gelatincapsule
Alsoreferredtoas“DFC”DryFilledCapsule.Manufacturedintotwosections,thecapsulebodyandas
hortercap.
ArecentinnovationincapsuleshelldesignistheSnap-Fit,Coni-
Snap,andConiSnapSuprohardgelatincapsules.
For human use, empty capsules ranging in size from 000 the largest to 5 the smallest. Generally,
hard gelatincapsuleisused to encapsulatebetween 65 mgto1gram.
Characteristic
 Usually use in the extemporaneous compounding of Rx.
 Made of gelatin, sugar and water.
 Clear. Colorless and essentially tasteless.
 Colored with FD & C and D & C dyes and made opaque by adding agents such as
titanium dioxide.
 Combination of colorants and opaqueness to make them distinctive, many with caps and
bodies of different colors.

Plasticizers: -
 The amount of plasticizers used to make the capsule to hard or soft.
 The plasticizers are used- Glycerin, Sorbitol.
Preservative: -

33
  If included, is generally a mixture of Methylparaben (4 Part) and Propylparaben (1
Part) to the extent of 0.2%.
Flavors: -
 If added, should not exceed 2%.

 Generally, the flavors are used- Ethyl vanillin or Essential Oils.

Sugar: -

 If included, may be up to 5% to give the gelatin shell desirable chewable characteristics.

Additives: -

a) Diluents: -

 Thediluentshavetobeaddedtobringthemedicament upto adesiredbulk.

 Thequantitiesofdiluentsarerelatedtothedoseof themedicamentandthe capsulesize.
b) Protective Sorbents: -

 Sometimes some inert materials are included to prevent the absorption of moisture by
hygroscopicsubstances.
 Materialslike–oxidesand carbonatesof MgorCa.

c) Glidants: -

 Glidants become essential when the powders are filled by automated machinery
requiring theirregularflowin thecapsulebodies.
 Glidantslike-Talc,Stearates.
d) Anti-Dusting Compounds: -

 These are the compounds which prevent the flow of dust particle of the drug in the
air to causeshealthhazards.
 Anti-dustingcompoundslike-inertedibleoils.
Gelatin
 It is obtained by the partial hydrolysis of collagen obtained from skin, white connective
tissue and bones of animals.
 Available in the form of a fine powder, a coarse powder, shreds, flakes, or sheets.
 Stable in air when become moist- subject to microbial decomposition.
 HGC contain 13 to 16% of moisture.
 Extreme dryness- capsule may become brittle and crumble.
Manufacture of Hard Gelatin Capsule

 Manufacturedinto2 sections,thecapsulebodyandtheshortercap.
 The2partsoverlap whenjoined,withthecapfittingsnuglyovertheopenend ofthe
capsulebody.
 Shellsareproducedbychemicaldippingofpinsorpegsofthedesiredshapeanddiameterinto
atemperature-controlledreservoirofmeltedgelatin mixture.
 The pegs made of manganese bronze, are affixed to plates, each capable of holding up
to about 500pegs.
34
  Each plate is mechanically lowered to the gelatin bath, the peg submerges to the
desired depth andmaintainedforthe desiredperiodtoachieve
theproperlengthandthicknessofcoating.
 Theplateandthepegsareslowlyliftedfromthe bathandthe gelatindriedbya gentle flow
oftemperature-andhumidity-controlled air.
 Whendried,eachcapsulepartistrimmedmechanicallytotheproperlengthandremoved from
thepegs,thecapsulebodies and caps arejoined.

Capsule Parameter as per I.P.

Product Dose Conversion Drugcontent(% Dissolution(

(m.g.) (m.g.) ) %)

amoxicillin 250 285 90-110 80

AmpicillinTri 250 287 92.5-104.5 75

hydrate

CephalexinMo 250 270 90-110 75

nohydrate

Doxycycline 100 116 90-120 65

Rifampicin 150 165 92.5-107.5 70

Filling Hard Capsule Shells

1. Use Punch Method

 Powderisplacedonasheetofa cleanpaperorporcelainplate,
 Using spatula - formed into a cake having a depth of approximately one-fourth to
one-third thelengthofthecapsulebody,
 Then empty capsule body is held between the thumb and forefinger and punched
vertically into thepowdercakerepeatedlyuntil filled,
2. Feton Capsule Filling

 Withemptycapsuleintheloadertray,thetrayplaced ontop ofthefillerunit,

 The loader inserts the capsules into thefillingunit and is removed, and the top plate
is lifted toseparatethecaps from thebodies,
 Thepowderisplacedontheunitandthecapsulebodies filled,
 Thetopplateisreturnedtotheunitandthecapsplaced onfilledcapsulebodies,

Process Capsule Filling

1. Milling/ Sieving of all Ingredients.

2. Blending Powder Blender / Empty Capsules.

3. Capsule Filler.
35
 4. Capsule.

5. Capsule Injection Screen.

6. Capsule check-Weighing system/ reject

7. Finished Capsules.

ProFill 100 - The ProFill 100 Capsule Filling Machine utilizes an advanced design for fool-
proof manualfilling of two-piece capsules. With the ProFill 100 machine, there is no need for
expensive capsule fillingequipmentand electrical/vacuum connection.
Finishing: -
Thefilledthesealedcapsulesnecessitatefinishingoperationbeforeinspection,bowlingorpackinginstri
psandlabeling. Thefollowingsteps areinvolvedinthefinishingprocess-

 Panpolishing.
 Clothdusting.
 Brushing.
 Sealing.
 Inspection(ROTOSORT).

Evaluation of Capsules: -

1. Uniformityofweight.
2. Contentofactiveingredientsincapsules.
3. Disintegration.
4. Dissolution.

UNIBIOTECH Formulation Productlist(Capsules&powder)

36
 S.N. Capsules&Powder

1 FOEPEP-L

2 FRAGICAL-M

3 FRAGICAL-SG

4 LUCIDOL-RP

5 MYLITRANS

6 MYLITRANS-P

7 NERGIPOT

8 OXIBANK

9 OXIBANK Q10

10 PANTOSHARP-D

QUALITYCONTROL

QualityAssurance&QualityControlinPharmaIndustry
QA: It is the sum total of the organized arrangements with the objective of ensuring that
products will beofthequalityrequiredfortheirintended use.
GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently
manufactured toaqualityappropriateto theirintended use.
QC:Is that part of GMP concerned with sampling, specification & testing, documentation &
releaseprocedures which ensure that the necessary & relevant tests are performed & the product
is released for useonlyafterascertainingitsquality.
QualityAssurance(QA)ManagementProcedure:

1. HowtowriteStandardOperatingProcedure:
 SOPdescribesstandard SOPformatthat youcan useimmediatelyforyourqualityprocedure.
 SOP has instructions on how to write a formal operating procedure for your systems
which yourpeoplecanfolloweveryday.
2. QualityDocumentationManagementandChangeControl:
 This SOP describes how to generate new quality documents or change control of existing
documents,review of quality documents, satellite file management, and role of document
author, approver,documentcontrol officerand satellitefileadministrator.
3. DocumentationRuleforGMPDocuments:
 This SOP describes the principles to be followed in GMP documents, entry of data and
information,signaturerequirementsandcorrectiontechniqueofincorrectlyentereddataorinf
ormation.
4. QualityDocumentation-Control,TrackingandDistribution:
 In this SOP you will find mainly the role of document control officer during the
37
 initiation, creation,circulationand approvalofnewqualityrelated documents.
 It also describes the procedure of modification and review of existing
document using adocumentationdatabase.
 Managementofexistingandsupersededdocumentsisalsoapartofthisprocedure.
 Youwillseealltheformsreferredduringtheinstructionareattachedatthe endoftheprocedure.
5. ShelfLifeofProduct:
 This simple SOP describes the meaning of shelf life and provides on how to interpret
shelf lives andstorage conditions for your raw materials from the Certificate of
Analysis, determining expiry
dateforyourfinishedproductsbyuseofrawmaterialdateofmanufacturingandtheirshelflives.

QualityControlwork(Summary)

Samplingof
activepharmaceuticalingredients,Excipients,finishedproduct&packingmaterialetc.

1. TestingofAPI(ActivePharmaceuticalIngredients).
2. Testingof excipients.
3. Testingofsampleprocess.
4. Testingof finishedproducts.
5. Testingofpackingmaterial.
6. Stabilitystudiesoffinishedproduct.
7. Maintenanceandcalibrationofinstruments.
8. Procurementofchemicalsandglassware.
9. Procurementofreferencestandard.
10. Procurementofmaintenanceofclustersformicrobiologicaltesting.
11. Tocertificateanalysis.
12. Tostudyproducts complaints.
13. Todestroythecontrolsampleaftersixmonthsofthedateof expiry.
Quality Control Department
a) Quality Control Sampling Section:
Responsibilities: -
 TodrawthesampleofRMfromstore.
 TodrawthesamplesofF.G.fromproductiondepartment.
 Tokeepcontrolsample forreference&forstabilitystudies.
 Finalinspectionofeach batch.
b)Quality Control Chemical Section:
Responsibilities: -
 CompleteanalysisofallRM/process&F.G.sampleasperprescribedstandard.
 Tosendreporttoproduction,store,QCoffice.
 Tocarryout stabilitytestingetc.
 Instrumentmaintenanceandcalibration.

c) Quality Control Microbiology Section:

Responsibilities: -
38
  MicrobiologicalanalysisofRM/process/FG/sample.
 Tosendreporttoproduction,store,QCoffice.
 Qualitycontrolpackagingmaterialtest.
 Tocarryout stabilitytesting.

d)Quality Control Office:

Responsibilities: -
 TomakecertificateofanalysisofR.M. &finishedproducts.
 Tomaintain&keeprecordsofanalysis&certificateofanalysis.

WORKING OF QUALITY CONTROL: -

VALIDATEDSAMPLINGSYSTEM

VALIDATEDANALYTICALINSTRUMENT

ANALYTICALVALIDATEDMETHOD

VALIDATEDANALYSIS

SUCCESSFULANALYSIS

List of Quality Control Instruments:

S.NO NAME MAKE/MANUFACTURER

1 Tabletdisintegrationmachine Campbellelectronics

2 Waterbathsix-holethermostaticcontrol JSGW

3 pHmeter ECIL

4 Magneticstirrer Reml

5 Friabilitytest apparatus I.EquipmentCors

6 Vacuumpump Tempo

7 Oven SEW

8 B.O.D. JRSC

9 HPLC WATERS(INDIA)

10 Sixstagedissolutionratetestapparatus Tabmachines

39
 11 Meltingpointapparatus IEC&JSGW

12 Laminarflow Klenzald

13 Flamephotometer Systronic

14 Digitalbalance ATCO

15 SpectrophotometerUV-1601(withCVT) Shaimadzu

Introduction
This the section essential for the quantitative & qualitative evolution of the raw material
providedbysupplier, mixture material during processing & finished product evaluation supplied by
chief manufacturingchemist. Here also sample of finished batches are regularly checked for their
validation. It consists of 3sections-

1. Chemicalsection.
2. Instrumentalsection.
3. Micro-biologicalsection.

1) Chemicalsection:
Inthissectionevaluationofdrug,elementalanalysis,mineralanalysis,extraction,ignition,lossond
ying,meltingpoint recordingprocessingarecarried out byfollowinginstruments: -
a) Test Tubes, Boiling Tubes, Pipette, Funnel, Beaker, Burette, Separating Funnel: -
 Thesearemadeupofborosilicateglass.
 Pipettesareavailablefrom1.50ml.
 Ammoniadistillationtestapparatus,boilingpointapparatus are alsoavailable.
 Separatingfunnelsarefrom250-500ml.
b) Magnetic Stirrer: -

 Usetodissolvethesample;theyhavealsotemperaturecontrolalongwithstirrerspeedsetup.
c) Kipp’s Apparatus: -
 Usedferroussulphidewithsulphuricacidtopreparehydrogensulphideusedforelementala
nalysis.
d) Elemental Water Bath: -
 Forgradualheatingfrom30-100C.
e) Melting Point Detector: -
 Readsupto500Candisautomaticelectricheater meltingisobservedthroughalens.
f) Muffle Furnaces: -
 Consistofasteelbodyinwhich¾ft.thicknessiscoatedby
silicabrickandglasswoolmayheatupto1000 degree Celsius
itcanhavecoarseandfinetemperaturesetup
alongwithtemperatureincreaseratecontroller.
g) Vacuum Oven: -
40
  It is also a cubic steel container like simple oven but have a well lockable air
tight- though with a glasswindowin it.
 Itisattachedwithpressuregauzethatreads0-760 mmHgVacuum.
 There are two outlets one of which is attached to the Vacuum pump and other is
open both are associatedwithlocks.
 Whenever Vacuum is to be created door is closely followed by locking the open
outlet. Vacuum outlet isopened and suction motor is start when Vacuum is
created up to desired value Vacuum lock is also close andVacuum remains
maintained up to theneed.
 Beforeopeningthedoorlockofopen, outletisopen tosucktheairintheoven.
 Itisusedto determinetheloss ondryingofthedrugs.
 Example-vitamin-B2-5-Phosphates.

h) Reagent Used in Analysis- Acid, Base: -

 Acids.e.g.-Sulphuricacid,HCl,Nitricacidetc.
 Bases. e.g.-NaOH,KOHetc.
 Otherse.g.–Distilledwater,alcohol,Chloroform,Acetone,
carbontetrachloride,BenzenePyridineetc.
 Saltse.g.–Ammoniumchloride,NaEDTA,Sodiumacetate, calciumchlorideetc.
 Gases.e.g.–HydrogenSulphide

2) Instrumentalsection.

In this section quantitative analysis of drugs, drug release extent specific rotation moisture
contentdetermination,TLCspotstudy,colony
counting,boneofinhabitationdeterminationetc.processesarecarriedout with
followinginstrument-
a) Electronic Balance
 Fortheweightvariationtestingofsoliddosage formwerandomlycollect
 10-20 tablets and weighting it and determine average weight of each tablet. It should not be
less than90%oftherequired weight and not morethan 110%.
 Weighingrangeis1-100 mg.
 Tolerancelimit+0.01mg.
 Itisused toweighingaccuratelythedruginsmallamount.

b) Friability Tester
 Thistestisdonefortheknowingtheamountoftabletislossduringthetransportationbythefriction
withthepackingorduringthemanufacturingprocess.
 Thefriabilityfortabletisnotmoreorless than10%oftheactualweight.

c) Hardness Tester
 Hardnessisthemainfactorwhicheffectsthedisintegration&dissolutiontime.
 For the hardness testing generally hardness tester is used.
Packaging Machines May be of the Following General Types:

 Blisterpacks,skinpacksandVacuumPackagingMachines.
41
 Bottlecaps equipment,Over-Capping,Lidding, Closing,SeamingandSealingMachines.
 CartooningMachines.
 Box,CaseandTrayForming,Packing,Unpacking,ClosingandSealingMachines.
 Cleaning,Sterilizing,CoolingandDryingMachines.
 Conveyors,AccumulatingandRelatedMachines.
 Feeding,Orienting,PlacingandRelatedMachines.
 FillingMachines:handlingliquidandpowderedproducts.
 PackageFillingandClosingMachines.
 Form,FillandSealMachines.
 Inspecting,DetectingandCheckweigherMachines.
 Palletizing,Depalletizing,Unitloadassembly.
 ProductIdentification:labelling,marking,etc.
 WrappingMachines.

42
 REFERENCE
1. Tablet-
 Pharmaceutics.Thescienceofdosageformsdesign.(M.E.Alton)
 Thetheoryandpracticeofindustrialpharmacy.
 Pharmaceuticaldosageforms:Tablets.Volume2.
 Pharmaceuticaldosageformsanddrugdeliverysystems.
 PharmaceuticalManufacturingHandbookProductionandProcesses.
2. Coating
 http://www.touchbriefings.com/pdf/17/pt031_p_rajabi_siahboomi.pdf
 http://www.pharmpedia.com/Tablet:Tablet_coating#Aspects_of_tablet_coating
 http://www.dipharmatech.com/pharmaceutical_technical_articles.html
 http://www.roehm.com/en/pharmapolymers.html
3. Capsule-
 L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and Practice of Industrial
Pharmacy(ThirdEd.).Lea&Fibiger, Philadelphia.
 http://www.wikipedia.org.

4. Qualitycontrol-
 Ashutoshkar,pharmaceuticalanalysis,theory,methodologyanddrugassay,volume2,
 www.ich.org
 www.fda.gov

43