Pharmaceutical Formulation and Quality Control: Tablets, Parenterals, Aerosols

Long Answers

1. Physics of Tablets and Quality Control

• Granulation: process of aggregating particles to improve flow and compressibility.
• Methods: wet granulation, dry granulation, direct compression.
• Quality control: hardness, friability, disintegration, dissolution, content uniformity.

2. Defects of Tablets and Processing Problems

• Defects: cracking, capping, lamination, sticking, picking.
• Causes: incorrect formulation, improper granulation, inadequate compression.

3. Physicochemical Properties of Preformulation

• Key properties: solubility, pKa, partition coefficient, stability, polymorphism, hygroscopicity.

4. Advantages and Disadvantages of Parenteral Products

• Advantages: rapid onset, high bioavailability, targeted delivery.
• Disadvantages: risk of infection, requires trained personnel, expensive.
• Quality control: sterility testing, pyrogen testing, particulate matter inspection.

5. Preparation of Aerosols and Their Components

• Components: propellant, concentrate, valve, actuator.
• Preparation: mixing, filling, sealing.

6. Formulation of Cold Cream

• Components: emulsifier, oil phase, water phase, preservatives.
• Preparation: mixing, heating, cooling.

7. Formulation of Hard Gelatin Capsules

• Filling: powder, granules, pellets.
• Components: capsule shell, filling material, sealing.

8. Legal and Official Requirements for Packaging Materials

• Requirements: compliance with pharmacopoeial standards, labeling, storage conditions.

Short Answers

1. Preformulation Study

• Definition: study of physical and chemical properties of a drug.
• Objective: to develop a stable, effective, and safe dosage form.

2. BCS Classification

• BCS: Biopharmaceutics Classification System — classification based on solubility and permeability.

3. Tablet Classification, Advantages, Disadvantages

• Types: compressed, coated, sustained release.
• Advantages: convenience, stability, dose accuracy.
• Disadvantages: difficulty in swallowing, potential for manufacturing defects.

4. Pelletization

• Steps: extrusion, spheronization, coating.

5. Binder and Glidant

• Binder: holds particles together.
• Glidant: improves flowability.

6. Types of Glass and Lyophilization

• Glass types: Type I, II, III.
• Lyophilization: freeze-drying process.

7. Isotonicity in Ophthalmic Preparations

• Importance: prevents irritation and ensures patient comfort.

8. Soft Gelatin Capsules

• Methods: rotary die process, reciprocating die process.

9. Quality Control for Aerosols

• Tests: leak testing, pressure testing, spray pattern evaluation.

10. Lipstick and Vanishing Cream

• Lipstick: lip balm / cosmetic stick product.
• Vanishing cream: moisturizing cream that absorbs quickly.