Introduction to Pharmaceutical Dosage Forms

Chemical substances and crude drug:

 Seldom used directly as medicines, but it must be converted into suitable dosage form
Drugs are grouped accdg:
- to method of preparation
- to physical property
- to method of administration
Dosage Forms
 Pharmaceuticals
 A preparation made to administer medication in measured or prescribed amounts
 Contains
 Active pharmaceutical ingredient (API)
 Excipients
 Non-drug
 Therapeutically inert

Classification According to the Method of Administration

 Oral Dosage Forms
 Parenteral Dosage Forms
 Rectal Dosage Forms
 Inhalation
 Topical Applications

ORAL DOSAGE FORMS

 Preparations to be taken orally
Example:
Tablet
Syrup
Capsule
PARENTERAL DOSAGE FORMS
 Preparations introduced to the body by injection through the skin, the mucous, or the serous membranes.
Example:
IV Fluids
Vaccines
Immunobiologicals
Conditions or situations when parenteral route is undertaken:
 When rapid drug action is desired as in emergency cases
 When the patient is uncooperative, unconscious, or unable to accept or tolerate medication by the oral route
 When the drug itself is ineffective by other routes
 Except for insulin which are commonly self-administered by diabetic patient
RECTAL DOSAGE FORMS
 Preparations employed for systemic effect or local action through the rectum
Examples:
Suppositories
Enemas
DOSAGE FORMS FOR INHALATION
 Preparations intended to be finally dispensed or vaporized to the mucous membranes of the lower part of the
respiratory tract
Examples:
Nebulizing solution
Inhaler
DOSAGE FORMS FOR TOPICAL APPLICATION
 Preparations intended to be applied on the skin or instilled into the eyes, nose, or ears.
Examples:
Creams
Lotions
Ointments
Ophthalmic, Nasal, Otic drops

Classification According to Physical Nature

 Liquids
 Extracts
 Parenteral
 IV admixture
 Ophthalmic preparations
 Medicated applications
 Powders
 Oral solid dosage forms
 Aerosols
 Radiopharmaceuticals
 Biological products

I. LIQUIDS
A. Solution
B. Emulsion
C. Suspension

A. SOLUTION
 A homogenous mixture that is prepared by dissolving a solid or liquid or gas in another liquid.
 Molecules of the solute or dissolved substances are dispersed among those of the solvent.
 Oral Solution (accdg. to USP 23 and NF 18)
 Liquid preparations intended for oral administration, that contain one or more substances with or
without flavouring, sweetening, or coloring agents dissolved in water or cosolvent water mixture
 Aqueous Solution
 Sweet or other viscid solution
 Non-aqueous solution
1. AQUEOUS SOLUTION
 Water is used as a vehicle or solvent
a. Water
 Purified water, USP
 Water for injection, USP
 Bacteriostatic Water for injection, USP
 Sterile water for inhalation, USP
 Sterile water for irrigation, USP
b. Aromatic Water
 Known as medicated water
 Clear saturated aq. Solutions of volatile oils or aromatic substances
 Used as flavored or perfume vehicle
c. Aqueous acids
 Official inorganic acid
 Of great importance in the pharmaceutical manufacturing
 Concentrated aq. Solutions
 Expressed in % by weight
 d. Diluted acids
 Aqueous acids with strength of 10% w/v except acetic acid with 6% strength w/v
 They are used for internal administration
 For manufacture of other preparations
e. Solution
 Contains one or more soluble chemical substances dissolved in water.
 They are used for specific therapeutic effect of the solute either internally or externally.
f. Douches
 Aqueous solutions directed against a part or into a cavity of a body
 Used as cleansing agent or antiseptic agent
g. Enemas
 Known as evacuation enemas
 They are rectal injections employed to evacuate the bowel retention enemas to influence the general
system by absorption or to affect locally the seat of disease.
h. Gargles
 Aqueous solutions used for treating the pharynx and nasopharynx by forcing air from the lung through
the gargle which is held on the throat.
i. Mouthwash
 Aqueous solution which are most often used for their deodorant, refreshing or antiseptic effect.
j. Juices
 Prepared from fresh ripe fruits
 Aqueous in character
 Used in making syrups which are employed as vehicles
k. Nasal solutions
 Designed to be administered to the nasal passages in the drops or spray form
Ex. Salinase
o NaCl
l. Otic Solutions
 Permits the administration of drops to the ear

2. SWEET OR VISCID AQ. SOLUTION

a. Syrup
 Concentrated solutions of sugar
 They are used as flavored syrup or medicated syrup
 85% w/v (NF)
b. Honey
 Thick liquid preparation somewhat allied to the syrup
 Used as a base instead of syrup
c. Mucilages
 Thick, viscid, adhesive liquids produced by dispensing gum in water
 Extracted with water the mucilaginous principles from vegetable substances
 They are used as an aid I dispensing insoluble substances in liquid
 Their colloidal character an viscosity help them prevent immediate sedimentation
d. Jellies
 Class of gels in which the structural matrix contains a high proportion of liquid, usually water.
 They are used as lubricants for surgical gloves, catheters and rectal thermometer.

3. NON-AQUEOUS SOLUTIONS
a. Collodion
 Liquid preparation containing pyroxillin in a mixture of ethyl ether and ethanol
 They are applied to the skin by means of a soft brush or other suitable applicator
 When the ether and ethanol have evaporated, they leave a film of pyroxillin on the surface
 b. Elixirs
 Clear, pleasantly flavored sweetened hydro-alcoholic liquids intended for oral use
 5-40% alcohol content
 They are used as flavors and vehicles
Aromatic elixirs
 Combination of elixir with low alcoholic concentration and high alcoholic concentration
 Low alcohol concentration = 8-10% alcohol
 High alcohol concentration = 75-78% alcohol
c. Glycerin or Glycerites
 Solutions or mixtures of medicinal substances in not less than 50% by weight of glycerin
d. Inhalation and Inhalants
 Inhalations are solutions of drugs administered by the nasal or respiratory route for local or systemic
effect
 Nebulizers are used for the administration of inhalations
 Inhalants are special class of inhalations which consists of drugs or combinations of drugs that by virtue
of high power pressure can be carried by air current to the nasal passage where they extend their
effects.
 The container used for its administration is an inhaler
e. Liniments
 Solutions or mixtures of various substances in oil, alcoholic solutions of soap or emulsions.
 They are intended for external application
 They are applied by being rubbed in the affected areas
f. Oleovitamins
 Fish liver oils diluted with edible vegetable oil
 Solutions of volatile substances that usually contain vitamin concentrate such as Vitamin A and
g. Spirits
 Known as essences are hydro-alcohol solutions of volatile substances
 Contains 50-90% alcohol
 Used medicinally by inhalation (Aromatic Ammonia Spirit)
 Used as flavouring agent (Orange Spirit)
h. Toothache drops
 Used for temporary relief of toothache by application of cotton saturated with the product into the
tooth decay

B. EMULSIONS
 A two-phased system prepared by combining two immiscible liquids one which is uniformly dispersed
through the other and consist of globules
 Third substance the emulsifying agent, is incorporated to prevent separation of the two-phases
2 phases
 Continue phase – liquid droplet, internal phase
 Discontinuous phase – external phase, dispersion medium
 If water is the internal phase , the emulsion is classified as w/o
 If water is the external phase, the emulsion is classified as o/w
Purposes of emulsion
 Improved drug solubility
 Increased drug solubility
 Prolonged drug action
 Improved taste
 Improved appearance

C. SUSPENSIONS
 A two-phase system consisting of finely divided solid dispersed in a solid, liquid or gas
  Suspending agent is added to ensure the homogeneity of the solid in the vehicle
Purposes of Suspensions
 Sustaining effect
 Stability
 Taste
 Basic solubility
a. Gels
 Semi solid system of either suspension made up of small inorganic particles or large organic
molecules interpenetrated by a liquid
b. Lotions
 Usually liquid suspensions or dispersions intended for external application to the body
c. Magma or Milk
 Aqueous of insoluble inorganic drugs and differ from gels mainly in that the suspended particles are
layers
d. Mixtures
 Aqueous liquid preparations which contain suspended insoluble, solid substances intended for
internal use

II. EXTRACTS
A. Tinctures
 Tinctures prepared from potent drugs are usually 10% strength
 100 ml of tincture has the activity of 10 gram of the drug
 Glycerin may be added to increase solubility and reduce precipitation
 Must be stored in light resistant containers
B. Fluidextracts
 Contains alcohol as a solvent or as a preservative or both
 Each mL contains the therapeutic constituents of 1 gram of the standard drug that it represents
 Also 100% tincture
 10 times as concentrated as tincture
C. Extracts
 Concentrated preparations of vegetable or animal drugs obtained by the removal of the respective
drug with suitable menstruum, evaporation of all or nearly all of the solvent and adjustment of the
residual masses or powders to the prescribed standard.

III. PARENTERAL PREPARATIONS

 Sterile preparations intended to be administered by injection under or through one or more layers
of the skin or mucous membranes
 They are usually packed in ampules or vials
A. Solutions ready for injection
B. Dry, soluble products ready to be combined with a solvent just prior to the used
C. Suspensions ready for injection
D. Dry, insoluble products ready to be combined with a vehicle just prior to use
E. Emulsions

IV. INTRAVENOUS ADMIXTURE

 Mixture of intravenous fluids and drugs to be administered by injection
A. Intravenous fluids
 Sterile , large volume solutions intended to be administered by IV infusions
 Contain sugar, amino acids, or electrolytes
B. Intravenous admixture
 Combination of one or more sterile products added to an IV fluid for administration
 The product are mixed in a suitable environment using aseptic technique
 C. Total Parenteral Nutrition
 Preparation containing calories, nitrogen and other nutrients in sufficient quantities
 Calories = Dextrose
 Protein hydrolysate = Nitrogen
 Electrolyte and Vitamins = Nutrients

V. OPHTHALMIC PREPARATIONS
 Sterile preparations to be used on the eyes
A. Solutions
 Intended for the eye
 Clear, sterile solution to be instilled into the eyes by the use of a dropper
B. Suspensions
 Dispersion of finely divided relatively insoluble drug substances in an aqueous vehicle containing
suitable suspending and dispersing agent
C. Ointments
 Intended for they eyes
 They contain medicinal agents added on the ointment base of white petrolatum or mineral oil either a
solution or as a micronized powder
 Limited to bedtime installation
D. Lens Care Products
 Sterile preparations to protect the lenses
 Wetting solutions
- To furnish hydrophilic coating over the hydraulic surface of hard contact lens surfaces
 Cleansing solutions
- Used to remove surface contaminants, lipids proteins and the like
 Disinfection solutions
- Isotonic
- In an acceptable pH range nonreactive with lens material and sterile solution which exhibit
 Soaking solutions
- Used to store and hydrate hard lenses hard lenses
 Artificial tears
- Solution intended to rewet hard lenses in Situ referred to as rewetting solutions or artificial
tears.

VI. MEDICATED APPLICATIONS

 Applied to the skin or inserted into body orifices in liquid, semi-solid, or solid forms.
A. Ointments
 Semi-solid preparations inserted for external applications to the skin or mucous membranes
 Medicated or non- medicated
B. Cataplasms or Poultice
 A soft mass of meals, herb, seed etc. usually applied hot in clothes.
 Intended to localize infectious materials in the body or to act as counterirritants.
C. Pastes
 Concentrate of absorptive powders dispersed in petrolatum or hydrophilic petrolatum
 They are stiff to the point of dryness
 Used in the treatment of oozing lesions to absorb serous secretions
D. Powders for external use
 Dusting powders
 Usually contain starch, talc, and zinc stearate
E. Dressings
 External applications resembling ointment used as covering or protection
 F. Creams
 o/w or w/o type
 o/w – shaving cream, hand cream, foundation cream, vanishing cream etc.
 w/o – cold cream, emollient cream
G. Plasters
 Adhere to the skin and attach as a dressing
 Intended to afford protection and support to furnish an occlusive or macerating action and to bring
medication in close contact to the skin
H. Suppositories
 Solid dosage forms of various weights and shapes
 Intended to be inserted into the rectum, vagina, or urethra
 Rectal suppositories
- Usually cylindrical and tapered to a point, forming a bullet-like shape
- Suppositories for adult weigh about 2 grams
 Vaginal Suppositories
- Aka Pessaries
- Oval-shaped
- 5 grams
 Urethral Suppositories
- Aka Bougies
- Long and tapered
- 60mm long, 4-5mm diameter

VII. POWDERS
 Is a mixture of finely divided drugs or chemical in a dry form
 May be used internally or externally
A. Oral Powders
 Finely divided powder intended to be dissolved in water or mixed with soft food prior to administration
 Effervescent granule in solution in water releases CO2 which masks for the taste of salty or bitter
medication
B. Dentrifices
 May be prepared in the form of bulk powder
 Contains soap or detergent, mild abrasive, and anticariogenic agent
C. Douche Powder
 Dissolved in water prior to use as antiseptic or cleaning agent for a body cavity
 Most commonly intended for vaginal use
 May also be formulated for nasal, otic, and ophthalmic use
D. Dusting Powder
 Locally applied for non-toxic preparations
 Have no systemic effects
 Applied as lubricants, protective, adsorbents, antiseptic, antipruritic, astringent and antiperspirant
E. Insufflations
 Finely divided powders introduced into the body cavities with the use of insufflators (powder blower)
F. Triturations
 Dilution of potent powdered drugs prepared by intimately mixing them with a suitable diluent in 1:10
dilutions
VIII. ORAL SOLID DOSAGE FORMS
A. Tablets
 Solid dosage forms containing drug substances with or without suitable diluents and prepared either by
compression or molding methods
 Advantages
- Convenience of administration
 - Accuracy and reproducibility of a dosing
- Increased of drug stability
- Easy of mass production
- Tabuletta
- Is solid pharmaceutical dosage forms containing drug substances with or without suitable
diluents and prepared either by compression or molding methods
- Dissolution is the rate- limiting step in the delivery of drug from a tablet to the systemic
circulation
- Compressed tablet
- Molded tablets
- Compressed tablets
- Sugar coated tablet (SCT)
- Film coated tablet (FCT)
- Enteric coated tablet (ECT)
- Multiple compressed tablet (MCT)
- Controlled-release tablet (CRT)
- Effervescent tablet
- Compressed suppositories of inserts
- Buccal and sublingual tablets
- Molded Tablets to Tablet Triturates
- Dispensing tablets (DT)
- Hypodermic tablets (HT)
Film coated tablets (FCT)
 The tablet is coated with a membrane of polymeric substances that improve physicochemical stability of the
drug and delays the rate of drug absorption
Enteric coated tablets (ECT)
 The tablet is coated with an acid-resistant substance that will dissolve only in less acidic portions of the
intestines
Chewable tablets
 The tablets are placed in the mouth, chewed and swallowed
Sugar coated tablets
 The tablet that contain active ingredient(s) of unpleasant taste may be covered with sugar to make it more
palatable
 This type of tablet should be administered in whole form
Effervescent tablets
 In addition to the drug substance, this contain sodium bicarbonate and an organic acid such as tartaric or citric
 In the presence of water, this additives react liberating carbon dioxide which acts as a disintegrator and
produces effervescence
Buccal tablets
 Tablets intended for buccal administration by inserting into the buccal pouch may dissolve or slowly; therefore,
they are formulated and compressed with sufficient pressure to give a hard tablet
Sublingual Tablets
 As those containing nitroglycerin, isoproterenol hydrochloride, are placed under the tongue
 Sublingual tablets dissolve rapidly and the drug substances are absorbed readily by this form of administration
Dispensing tablets
 this tablet provide a convenient quantity of potent drug that can be incorporated readily powders and liquids,
thus circumventing the necessity to weigh small quantities
Hypodermic tablets (HT)
 soft, readily soluble tablets originally were used for the preparation of solutions to be injected

B. Capsules
 Solid dosage forms in which the drug substance is enclosed in either a hard or soft soluble container or
of a suitable form of gelatine
  The hard-shell gelatine capsules contain solid drugs
 The soft-shell gelatine capsules contain oils
C. Pills
 Small, round, solid dosage form containing medicinal agents
 Intended for oral administration
D. Troches
 Lozenges, pastilles
 Discoid shaped soli containing the medicinal agent in a suitably flavoured base
 Placed in the mouth where they slowly dissolve, liberating the active ingredient
Pastilles
 They are solid medicated preparations designed to slowly dissolve in the mouth
 They are softer than lozenges and their base are either glycerol and gelatine, or acacia and sugar
E. Cachets
 Related to capsule
 They provide an edible container
 Vary in size, ¾ to 1/8 inches in diameter
 Consist of two concave pieces of water made of flour and water
F. Pellets
 Small sterile cylinders of about 3.2 mm in diameter by 8 mm in length
 Formed by compression from medicated masses
 Implanted under the skin

Modified-Release Dosage Form

 Extended release products are designed to release their medication in a controlled manner at a predetermined
rate, duration, and location to achieve and maintain optimum therapeutic blood levels of drug
 Sustained Release (SR)
 Sustained Action (SA)
 Extended Release (ER)
 Long Acting (LA)
 Prolong Action (PA)
 Controlled Release (CR)
 Timed Release (TR)
 Modified Release (MR)
 Delayed Release
 Repeat Action

IX. AEROSOLS
 Used both orally and topically
 They contain therapeutically active ingredients dissolved, suspended, or emulsified in a propellant or in a
mixture of a solvent or a propellant
 Oral aerosols – tx of asthma, migraine headache
 Topical aerosol – dermatological diseases
 Radioisotopes used in medicine for therapeutic and diagnostic purposes
A. Biologics for Active Immunity
 Toxoid
- A modified antigen from an infectious organism used as a vaccine
B. Biologics for Passive Immunity
 Human Immune Sera
- Immune globulin – a solution containing antibodies of pooled plasma of not less than 1,000
normal individuals
- Hyperimmune Sera – a special preparation obtained from human donor selected for high
antibody titer against specific disease
  Animal Immune Serum
- Antitoxin – a solution of antibodies derived from the serum of animals immunized with specific
toxins (toxoids) used to achieve passive immunity or to effect a treatment
- Antiviral Serum – a solution of antibodies derived from the serum of animals immunized with
specific viral vaccines
- Antivenin – a preparation of antibodies derived from the serum of animals immunized with
specific venom used to neutralize the venoms produced by specific organisms

Use of Leading Verb in Direction to Patient to Denote the Method of Administration

 Apply
 Chew
 Crush
 Drink
 Dissolve
 Gargle
 Give
 Inhale
 Inject
 Insert
 Instil
 Irrigate
 Place
 Put
 Rub
 Shampoo
 Soak
 Spray
 Swallow
 Take
 Use
 Wash