GPAT Pharmaceutics Syllabus

Pharmaceutics syllabus — full chapter and topic list

Expand any chapter to see its topics and sub-topics. This is the whole examinable outline for Pharmaceutics in GPAT, not a summary of it.

1. 1

   Pharmacy Profession & Introduction to Pharmaceuticals

   8 topics

   • Introduction to dosage form
   • Biological products
   • Pharmaceutical Plant, location, layout
   • Ophthalmic preparations
   • Pre formulation
   • Packaging Materials
   • Cosmetics
   • Pilot plant scale-up techniques
2. 2

   Dosage Form Necessities and Additives

   8 topics

   • Powders
   • Sources of drug information
   • Tablets
   • Parenteral - product requiring sterile packaging
   • Suspensions
   • Emulsions
   • Suppositories
   • Stability of formulated products
3. 3

   Prolonged Action Pharmaceuticals

   9 topics

   • Novel Drug delivery system
   • GMP and Validation
   • Semisolids
   • Allopathic dosage form
   • Crude extract
   • Allergenic extract
   • Capsules
   • Liquids (solutions, syrups, elixirs, spirits, aromatic water, liquid for external uses)
   • Pharmaceutical Aerosols

Pharmaceutics flashcards for GPAT

20 of 78 cards from the Pharmaceutics deck — real questions with worked answers.

1. What is a dosage form, and why are drugs formulated into them rather than given as pure drug?

   A dosage form is the physical form (e.g., tablet, capsule, injection, syrup) in which a drug is presented for administration. Drugs are formulated to ensure accurate dosing, protect the drug, mask taste, improve stability, aid identification, and deliver the drug to the desired site of action.

2. Classify dosage forms based on physical state, giving an example of each.

   Solid (tablets, capsules, powders), Semisolid (ointments, creams, gels, suppositories), Liquid (solutions, syrups, suspensions, emulsions), and Gaseous (aerosols, inhalations, oxygen).

3. What is preformulation in pharmaceutical development?

   Preformulation is the stage of investigating the physicochemical properties of a new drug substance (alone and with excipients) before formulation, to generate data that guides a stable, safe, effective and bioavailable dosage form.

4. Name the key physicochemical parameters studied during preformulation.

   Solubility, pKa/ionization, partition coefficient (log P), dissolution, particle size/shape, polymorphism, crystallinity, hygroscopicity, melting point, organoleptic properties, stability, and drug-excipient compatibility.

5. Define partition coefficient (log P) and its significance in preformulation.

   Partition coefficient is the ratio of a drug's equilibrium concentrations in an organic phase (usually octanol) to an aqueous phase. It indicates lipophilicity, predicting membrane permeability and absorption; an optimal log P (~1-3) generally favors good absorption.

6. What is polymorphism and why is it critical in preformulation?

   Polymorphism is the ability of a solid drug to exist in more than one crystalline form. Polymorphs differ in solubility, dissolution rate, stability and bioavailability, so the most stable yet bioavailable form must be selected and controlled.

7. State the Noyes-Whitney equation and what it describes.

   dC/dt = (D·A·(Cs − C))/h, where dC/dt = dissolution rate, D = diffusion coefficient, A = surface area, Cs = saturation solubility, C = concentration in bulk, h = diffusion layer thickness. It describes the rate of drug dissolution.

8. What are the main sources of drug information, classified into three categories?

   Primary sources (original research articles, journals, clinical trials), Secondary sources (indexing/abstracting services like Medline, IPA, Chemical Abstracts), and Tertiary sources (textbooks, pharmacopoeias, reference works like Martindale, USP, Remington).

9. Name three official pharmacopoeias used as drug information sources.

   Indian Pharmacopoeia (IP), United States Pharmacopeia (USP-NF), and British Pharmacopoeia (BP). (Others include European Pharmacopoeia and International Pharmacopoeia.)

10. What factors are considered when selecting the location of a pharmaceutical plant?

    Availability of raw materials, water and power supply, transport/communication, labor availability, climate, waste disposal facilities, proximity to market, government incentives/regulations, and land cost/expansion scope.

11. What are the main objectives of a good pharmaceutical plant layout?

    To ensure smooth material flow, minimize cross-contamination, maintain GMP compliance, optimize space and labor, ensure safety, facilitate cleaning and maintenance, and allow logical sequence of operations with future expansion.

12. Define GMP (Good Manufacturing Practice).

    GMP is a system of quality assurance ensuring that pharmaceutical products are consistently produced and controlled according to quality standards appropriate to their intended use, covering all aspects of production from materials to personnel and premises.

13. What is validation in pharmaceutical manufacturing?

    Validation is documented evidence providing a high degree of assurance that a specific process, equipment, or system will consistently produce a product meeting its predetermined specifications and quality attributes.

14. Name the four main types of process validation.

    Prospective validation (before routine production), Concurrent validation (during routine production), Retrospective validation (using historical batch data), and Revalidation (re-establishing validity after changes).

15. What are the three stages of qualification before process validation?

    Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). (Often preceded by Design Qualification, DQ.)

16. What is pilot plant scale-up?

    Pilot plant scale-up is the process of transferring a formulation and its manufacturing process from laboratory (bench) scale to an intermediate (pilot) scale before full commercial production, to identify and resolve scale-related problems.

17. List the main objectives of a pilot plant.

    To evaluate and validate the process, identify critical process parameters, optimize equipment and procedures, produce batches for stability/clinical studies, estimate costs, and ensure smooth transfer (technology transfer) to production scale.

18. What are the official standards for water used in pharmaceutical manufacturing?

    Purified Water (for non-parenteral products), Water for Injection (WFI, pyrogen-free, for parenterals), and Sterile Water for Injection. Specifications are defined in pharmacopoeias for each grade.

19. Define a tablet as a dosage form.

    A tablet is a solid unit dosage form containing a drug with or without suitable excipients, prepared by compression or molding, intended for oral, buccal, sublingual, or other routes of administration.

20. What are the three main methods of tablet manufacture?

    Wet granulation, Dry granulation (slugging or roller compaction), and Direct compression.

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