GPAT Pharmaceutics Syllabus

List the major categories of tablet excipients with their function.

Diluents (bulk), Binders (cohesion), Disintegrants (break-up), Lubricants (reduce die-wall friction), Glidants (improve flow), Antiadherents (prevent sticking), and Coloring/flavoring/sweetening agents.

Name common tablet defects and give two examples.

Capping (separation of top), Lamination (separation into layers), Picking (material sticking to punch face), Sticking, Mottling (uneven color), Chipping, Cracking, and Weight variation.

What official tests are performed on tablets for quality control?

Weight variation/uniformity of content, hardness, friability, disintegration time, dissolution test, and thickness/diameter.

Define a capsule and distinguish the two main types.

A capsule is a solid dosage form in which the drug is enclosed in a gelatin (or HPMC) shell. Hard gelatin capsules (two-piece, for powders/granules) and Soft gelatin capsules (one-piece sealed, for liquids/oily/semisolid fills).

What are the standard hard gelatin capsule sizes from largest to smallest?

000 (largest), 00, 0, 1, 2, 3, 4, 5 (smallest). Size 000 holds the most fill, size 5 the least.

What is the basic composition of a hard gelatin capsule shell?

Gelatin, water, plus colorants, opacifying agents (titanium dioxide), and preservatives. Soft capsules additionally contain a plasticizer such as glycerin or sorbitol.

Define a pharmaceutical solution and its key characteristic.

A solution is a clear, homogeneous liquid preparation containing one or more dissolved solutes (solid, liquid, or gas) molecularly dispersed in a solvent. It is monophasic and the drug is fully dissolved.

Differentiate syrups, elixirs, and spirits.

Syrups are concentrated aqueous sugar solutions of drugs (sweet, viscous, no/low alcohol). Elixirs are clear, sweetened hydroalcoholic solutions. Spirits (essences) are alcoholic or hydroalcoholic solutions of volatile substances.

What is an aromatic water?

Aromatic waters are clear, saturated aqueous solutions of volatile oils or other aromatic/volatile substances, used as flavoring agents or mild vehicles (e.g., peppermint water, chloroform water).

What is the concentration of sucrose in Simple Syrup IP and why is it self-preserving?

Simple Syrup contains about 66.7% w/w (approximately 85% w/v) sucrose. The high sugar concentration creates high osmotic pressure that inhibits microbial growth, making it self-preserving.

Define a pharmaceutical suspension.

A suspension is a biphasic (heterogeneous) liquid dosage form in which finely divided insoluble solid particles (the dispersed phase) are uniformly dispersed in a liquid vehicle (the continuous phase).

Differentiate flocculated and deflocculated suspensions.

Flocculated: particles form loose aggregates, settle fast as a high, easily redispersible loose sediment, no caking. Deflocculated: particles settle slowly as individual particles forming a dense, hard cake that is difficult to redisperse.

State Stokes' law and its relevance to suspension stability.

v = d²(ρs − ρl)g / 18η, where v = sedimentation velocity, d = particle diameter, ρs/ρl = densities of solid/liquid, g = gravity, η = viscosity. Reducing particle size and increasing viscosity slows settling, improving suspension stability.

Define an emulsion and its two basic types.

An emulsion is a biphasic system in which one immiscible liquid is dispersed as droplets in another. Types: oil-in-water (o/w, oil dispersed in water) and water-in-oil (w/o, water dispersed in oil).

What is the HLB system and what HLB ranges suit o/w vs w/o emulsions?

HLB (Hydrophilic-Lipophilic Balance) is a scale (0-20) ranking emulsifier polarity. HLB 8-18 favors o/w emulsions; HLB 3-6 favors w/o emulsions; 13-15 for detergents, 15-18 for solubilizers.

Name the methods used to identify the type of an emulsion.

Dilution test, Dye solubility test (water-soluble dye like amaranth colors o/w continuous phase), Conductivity test (o/w conducts), and Fluorescence test.

List common instabilities of emulsions.

Creaming (reversible upward/downward droplet movement), Cracking/breaking (irreversible coalescence and separation), Phase inversion, and Flocculation.

Define semisolid dosage forms and name the main types.

Semisolids are preparations of soft, spreadable consistency for application to skin or mucous membranes. Types: ointments, creams, pastes, gels, and jellies.

Classify ointment bases into four categories.

Oleaginous (hydrocarbon) bases, Absorption bases, Water-removable (o/w emulsion) bases, and Water-soluble bases (e.g., PEG).

Differentiate ointments, creams, and pastes.

Ointments are greasy, anhydrous/oily semisolids. Creams are emulsion-based (o/w or w/o), less greasy and spreadable. Pastes contain a high proportion (≥20-50%) of finely powdered solids, making them stiff and absorptive.

Define a suppository and name the routes of administration.

A suppository is a solid dosage form intended for insertion into body cavities where it melts, softens, or dissolves to release drug. Routes: rectal, vaginal (pessary), and urethral (bougie).

Name the common suppository bases and give an example of each type.

Fatty/oleaginous bases (theobroma/cocoa butter, hard fat) which melt at body temperature, and water-soluble/water-miscible bases (glycerin-gelatin, PEG/macrogol) which dissolve in body fluids.

What is the displacement value of a drug in suppository preparation?

Displacement value is the number of parts by weight of drug that displaces one part by weight of the suppository base (e.g., cocoa butter). It is used to calculate the correct amount of base needed when incorporating drugs.

What are parenteral preparations and why must they be sterile?

Parenterals are sterile dosage forms administered by injection, bypassing the gastrointestinal tract (e.g., IV, IM, SC). They must be sterile, pyrogen-free, and particulate-free because they bypass the body's natural protective barriers, going directly into tissues/blood.

What are pyrogens, and how is Water for Injection rendered pyrogen-free?

Pyrogens are fever-producing substances (mainly bacterial endotoxins/lipopolysaccharides). WFI is made pyrogen-free by distillation (or reverse osmosis); pyrogens can also be destroyed by dry heat (250°C) and removed by ultrafiltration or adsorption.

Name the official methods of sterilization for parenterals.

Moist heat (autoclaving, 121°C/15 psi/15 min), Dry heat (160-180°C), Filtration (0.22 µm membrane for heat-labile solutions), Gaseous (ethylene oxide), and Radiation (gamma/UV) sterilization.

What quality control tests are mandatory for parenteral products?

Sterility test, Pyrogen test (rabbit) / Bacterial Endotoxin Test (LAL), Clarity (particulate matter) test, Leak test, and Uniformity of volume/content.

What are the special requirements/containers for parenteral packaging?

Parenterals require sterile, sealed, tamper-evident containers: ampoules (single dose), vials (single/multi-dose), infusion bottles/bags, and prefilled syringes, made of Type I/II/III glass or suitable plastic, ensuring sterility and integrity.

Define ophthalmic preparations and list their key requirements.

Ophthalmic preparations are sterile products (solutions, suspensions, ointments) applied to the eye. They must be sterile, isotonic, of suitable pH, particle-free (no irritation), and preferably preserved (for multidose) with no toxic effects.

Why are eye drops adjusted to be isotonic, and what tonicity range is tolerated?

Isotonicity (equivalent to 0.9% NaCl) prevents discomfort and tissue damage. The eye tolerates a range roughly equivalent to 0.5%-1.6% NaCl, but ideal is isotonic to minimize irritation and lacrimation.

What is a pharmaceutical aerosol?

A pharmaceutical aerosol is a pressurized dosage form containing drug in solution or suspension that, on actuation of a valve, is dispensed as a fine mist, foam, or spray by a propellant for inhalation, topical, or other use.

Name the essential components of a pharmaceutical aerosol system.

Container, Propellant (provides pressure/expulsion), Concentrate (drug + solvent/co-solvent), Valve and actuator, and the Dip tube. Propellants may be liquefied gases (HFAs) or compressed gases.

What is meant by stability of formulated products, and name the types of stability.

Stability is the capacity of a product to retain its physical, chemical, microbiological, therapeutic, and toxicological specifications within limits throughout shelf life. Types: chemical, physical, microbiological, therapeutic, and toxicological stability.

What are the main chemical degradation pathways of drugs?

Hydrolysis, Oxidation, Reduction, Photolysis (light-induced), Racemization, and Polymerization. Hydrolysis and oxidation are the two most common.

State the Arrhenius equation and its use in stability/accelerated studies.

k = A·e^(−Ea/RT), where k = rate constant, A = frequency factor, Ea = activation energy, R = gas constant, T = absolute temperature. It relates reaction rate to temperature, allowing prediction of shelf life from accelerated (elevated temperature) studies.

What are the ICH long-term and accelerated stability storage conditions (Zone IVb / general)?

Long-term: typically 25°C/60% RH (or 30°C/65-75% RH for hot-humid zones). Accelerated: 40°C/75% RH for 6 months. Intermediate: 30°C/65% RH.

What is the primary function of packaging materials in pharmaceuticals?

To protect the product from environmental factors (moisture, light, oxygen, microbes, mechanical damage), ensure stability and identification, provide convenience, and maintain product integrity until use.

Differentiate primary, secondary, and tertiary packaging.

Primary packaging is in direct contact with the product (e.g., blister, vial, bottle). Secondary packaging holds primary packs (e.g., carton). Tertiary packaging is for bulk transport/storage (e.g., shipping cartons, pallets).

Classify glass used in pharmaceutical containers (Types I-IV).

Type I: borosilicate (highly resistant, for parenterals/buffered). Type II: treated soda-lime (de-alkalized, for acidic/neutral parenterals). Type III: regular soda-lime (non-parenteral/powders). Type IV (NP): general-purpose soda-lime for non-parenteral oral/topical.

What are biological products in pharmacy?

Biological products are preparations derived from living organisms used for prevention, treatment, or diagnosis of disease, such as vaccines, sera (antisera), antitoxins, toxoids, blood products, and antibiotics produced by microorganisms.

Differentiate active and passive immunization with examples.

Active immunization stimulates the body to produce its own antibodies (vaccines, toxoids) giving slow but long-lasting immunity. Passive immunization provides preformed antibodies (antisera, immunoglobulins, antitoxins) giving immediate but short-lived immunity.

Differentiate a vaccine, a toxoid, and an antitoxin.

A vaccine contains attenuated/killed organisms or antigens to induce active immunity. A toxoid is an inactivated (detoxified) bacterial toxin used to induce active immunity (e.g., tetanus toxoid). An antitoxin is a preformed antibody against a toxin used for passive immunity.

What is an allergenic extract and its use?

Allergenic extracts are preparations of allergens (from pollens, molds, dust, foods, animal danders) used for diagnosis (skin testing) and treatment (desensitization/immunotherapy) of allergic conditions.

What is a crude extract / crude drug?

A crude drug is a natural product (plant, animal, or mineral) that has undergone only collection and drying with no further processing. A crude extract is a concentrated preparation obtained by treating crude drug with a solvent and removing it, containing the active constituents.

Classify pharmaceutical extracts based on consistency.

Liquid extracts (fluid extracts), Semisolid/soft extracts (pilular), and Dry/powdered extracts. They differ in the amount of solvent removed and resulting consistency.

What are allopathic dosage forms?

Allopathic dosage forms are the conventional modern-medicine preparations (tablets, capsules, injections, syrups, ointments, etc.) used in the allopathic (mainstream Western medicine) system to treat disease by counteracting symptoms.

Define cosmetics and distinguish from cosmeceuticals.

Cosmetics are articles applied to the body for cleansing, beautifying, or altering appearance without affecting structure/function (e.g., lipstick, shampoo). Cosmeceuticals are cosmetic products with active ingredients claiming therapeutic/biological benefits (e.g., anti-aging creams with retinoids).

Name the main types of cosmetic preparations with an example of each.

Skin care (creams, lotions), Hair care (shampoos, conditioners, dyes), Oral care (toothpaste, mouthwash), Decorative (lipstick, nail polish, eyeliner), and Fragrances (perfumes, deodorants).

What are the basic ingredients of a toothpaste (dentifrice)?

Abrasives/polishing agents (calcium carbonate, silica), Humectants (glycerin, sorbitol), Binders/thickeners, Surfactants/foaming agents (SLS), Sweeteners and flavors, and Therapeutic agents (fluoride for anticaries).

Define a Novel Drug Delivery System (NDDS).

An NDDS is an advanced approach to delivering drugs that improves efficacy, safety, and patient compliance by controlling the rate, time, and/or site of drug release compared to conventional dosage forms.

Differentiate sustained-release and controlled-release dosage forms.

Sustained-release prolongs drug release to maintain therapeutic levels over an extended time but with some fluctuation. Controlled-release delivers the drug at a predetermined, constant (often zero-order) rate, maintaining steady plasma concentration independent of conditions.

Name common carrier/vesicular systems used in NDDS.

Liposomes, Niosomes, Nanoparticles, Microspheres, Nanoemulsions, Dendrimers, Transdermal patches, and Implants.

What is a liposome?

A liposome is a microscopic, spherical vesicle composed of one or more concentric phospholipid bilayers enclosing an aqueous core, capable of carrying both hydrophilic (in the core) and lipophilic (in the bilayer) drugs for targeted/controlled delivery.

Define powders as a dosage form and distinguish bulk vs divided powders.

Powders are dry mixtures of finely divided drugs and/or excipients for internal or external use. Bulk powders are supplied in multidose containers (patient measures dose, for non-potent drugs); Divided powders (chartulae) are individually wrapped single-dose units.

What is geometric dilution and why is it used in powder mixing?

Geometric dilution is mixing a small quantity of potent drug with an equal volume of diluent, then continuing to add diluent in increasing (doubling) amounts. It ensures uniform, homogeneous distribution of a small amount of potent drug throughout the mixture.

What is an effervescent powder/granule and how does it work?

Effervescent powders contain an acid source (citric/tartaric acid) and a base (sodium bicarbonate) that, when dissolved in water, react to release carbon dioxide, producing effervescence that improves palatability and aids dissolution.

What is an insufflation and a dusting powder?

An insufflation is a finely divided powder introduced into body cavities (ear, nose, throat) using an insufflator. A dusting powder is a fine external powder applied to the skin for lubricant, protective, antiseptic, or absorbent purposes.

What is the difference between disintegration and dissolution tests for tablets?

Disintegration measures the time for a tablet to break into smaller particles/granules in a fluid. Dissolution measures the rate and extent to which the drug actually goes into solution. Dissolution better correlates with bioavailability.