1.

Types of glass containers – Type I (Borosilicate glass), Type II (Treated

soda-lime glass), Type III (Soda-lime glass), Type IV (General-purpose
glass).

2. Metal containers – Aluminum, Tin, Stainless steel.

3. Sorbitol – A sugar alcohol used as a sweetener and humectant in

pharmaceuticals.

4. Examples of semisolid excipients – Petrolatum, Lanolin, Waxes,

Polyethylene glycols.

5. Statistical design of optimization – Use of statistical techniques like

factorial design, response surface methodology (RSM) to optimize
formulations.

6. Advantages of quality by design (QbD) – Improved product quality,

reduced variability, regulatory flexibility, cost-effectiveness.

7. Water-soluble organic solvents – Ethanol, Propylene glycol, Glycerin,

Polyethylene glycol (PEG).

8. Numerical optimization techniques – Gradient descent, Genetic

algorithms, Simulated annealing, Newton-Raphson method.

9. Fractional factorial design – A subset of a full factorial design used to

reduce experimental runs while maintaining key interactions.

10. Pharmaceutical product development – Process of designing, testing,

and optimizing drug formulations for safety, efficacy, and regulatory
approval.

11. Evaluation test for granules – Bulk density, Tapped density, Angle of
repose, Moisture content, Particle size distribution, Flowability.
12. Objectives of pharmaceutical product development – Ensure drug stability,
Improve bioavailability, Enhance patient compliance, Achieve regulatory
approval.
13. Non-ionic surfactants – Surface-active agents that do not ionize in solution,
e.g., Polysorbates (Tween), Sorbitan esters (Span).
14. Gelling agents – Substances that increase viscosity and form gels, e.g.,
Carbopol, Xanthan gum, Hydroxypropyl methylcellulose (HPMC).
15. Coating materials – Substances used to coat tablets for protection, taste-
masking, and controlled release, e.g., Hydroxypropyl cellulose, Shellac,
Titanium dioxide.
16. Advantages of binders – Improve tablet hardness, Enhance compressibility,
Ensure uniform drug distribution, Reduce friability.
17. Multilevel and multiobjective optimization – Multilevel optimization
involves solving hierarchical problems, while multiobjective optimization
deals with optimizing multiple conflicting objectives simultaneously.
18. Factors and trials – Factors are independent variables affecting outcomes,
while trials are experimental runs conducted to study these factors.
19. Device packaging – The process of enclosing medical devices in sterile,
protective, and regulatory-compliant packaging.
20. Functions of pharmaceutical packaging – Protects drug stability, Ensures
patient safety, Provides dosage information, Enhances product identification.
21. Advantages of plastic containers – Lightweight, Cost-effective, Shatter-
resistant, Chemical resistance, Flexible designs.
22. Secondary packaging – Outer packaging that protects primary packaging,
e.g., cartons, boxes, shrink wraps.
23. Applications of surfactants and examples – Used as emulsifiers,
solubilizers, wetting agents, and detergents; examples: Polysorbates (Tween),
Sodium lauryl sulfate, Lecithin.
24. Suspending agents – Substances that prevent sedimentation of particles in
suspensions, e.g., Xanthan gum, Methylcellulose, Bentonite, Carbopol.
25. Types of variable optimization – Continuous, Discrete, Categorical, Mixed-
variable optimization.
26. Objectives of quality by design (QbD) – Improve product quality, Reduce
variability, Enhance process understanding, Ensure regulatory compliance.
27. Water-insoluble organic solvents – Ethyl acetate, Benzene, Chloroform,
Toluene.
28. Full factorial design – An experimental design where all possible
combinations of factors and levels are tested.
29. Pharmaceutical excipient - II – Includes categories like lubricants,
disintegrants, colorants, and preservatives used in formulations.
30. Classification of emulsifying agents – Natural (Acacia, Lecithin), Synthetic
(Tweens, Spans), Finely divided solids (Bentonite, Magnesium hydroxide),
Amphiphilic macromolecules (Gelatin, Casein).
31. Objectives of pharmaceutical product development – Ensure drug stability,
Improve bioavailability, Enhance patient compliance, Achieve regulatory
approval.
32. Stability indicating assay method – A validated analytical method used to
detect and quantify the active pharmaceutical ingredient (API) and its
degradation products under stress conditions.
33. Role of alcohol as solvents – Used as a co-solvent to dissolve poorly water-
soluble drugs, enhance drug absorption, and act as a preservative in
formulations.
34. Examples of suspending agents – Xanthan gum, Methylcellulose, Bentonite,
Carbopol.
35. Lubricants and sorbents – Lubricants reduce friction during tablet
compression (e.g., Magnesium stearate), while sorbents absorb moisture and
improve stability (e.g., Silica gel).
36. Anti-adherents – Agents that prevent tablet sticking to punches and dies
during compression, e.g., Talc, Magnesium stearate, Starch.
37. Confounding – A situation in experimental design where the effect of one
factor is mixed with another, making it difficult to distinguish their individual
impacts.
38. Optimization benefits for industry – Cost reduction, Improved product
quality, Increased efficiency, Better regulatory compliance.
39. Types of packaging – Primary (Direct contact with drug, e.g., Blister packs),
Secondary (Outer protection, e.g., Cartons), Tertiary (Bulk transport, e.g.,
Pallets).
40. Compliance – Adherence to regulations, guidelines, and prescribed drug
usage to ensure safety and efficacy in pharmaceuticals.
41. Types of packaging materials – Glass, Plastic, Metal, Paper, Rubber.
42. Advantages of metal containers – Durable, Protects from light and moisture,
Tamper-resistant, Recyclable.
43. Pre-formulation – The initial phase in drug development where physical,
chemical, and mechanical properties of a drug substance are studied to
optimize formulation.
44. Types of suspending agents – Natural (Acacia, Tragacanth), Synthetic
(Carbopol, Sodium carboxymethyl cellulose), Inorganic (Bentonite,
Magnesium hydroxide).
45. Examples of semisolid excipients – Petrolatum, Lanolin, Waxes,
Polyethylene glycols.
46. Evaluation test for closures – Seal integrity, Leak test, Compatibility test,
Torque test.
47. Directly compressible vehicles – Excipients that allow tablet compression
without granulation, e.g., Microcrystalline cellulose, Spray-dried lactose.
48. Capsule excipients – Fillers (Lactose, Starch), Lubricants (Magnesium
stearate), Disintegrants (Croscarmellose sodium), Surfactants (Sodium lauryl
sulfate).
49. Optimization – The process of improving formulation or process parameters
to achieve the best possible outcome in pharmaceutical development.
50. Directly compressible vehicles – Excipients used in tablet formulation that
enable direct compression without prior granulation.
51. Advantages of plastic containers – Lightweight, Cost-effective, Shatter-
resistant, Flexible, Resistant to chemicals.
52. Examples of non-ionic surfactants – Polysorbates (Tween 80), Sorbitan
esters (Span 60), Polyethylene glycol (PEG), Lecithin.
53. Excipients – Inactive substances used in drug formulations to aid processing,
stability, and drug delivery.
54. Types of solvents – Aqueous (Water, Ethanol), Organic (Chloroform,
Acetone), Semi-polar (Methanol, Isopropanol).
55. Uses of polyethylene glycol (PEG) – Solvent, Plasticizer, Lubricant,
Emulsifier, Base for ointments.
56. Benefits of quality by design (QbD) – Improved product quality, Reduced
variability, Cost-effectiveness, Regulatory flexibility.
57. Raw materials used for packaging – Glass, Plastic, Metal, Rubber,
Paperboard.
58. Aerosol – A pressurized dosage form that dispenses a fine mist or spray
containing active pharmaceutical ingredients.
59. Different types of tablet coating – Sugar coating, Film coating, Enteric
coating, Compression coating.
60. Optimization techniques – Methods used to improve formulation and
processes, e.g., Response Surface Methodology (RSM), Factorial Design,
Genetic Algorithms.
1. Advantages of Glass Containers

• Chemically inert and non-reactive with drugs.

• Provides excellent barrier properties against moisture and gases.

• Transparent, allowing easy inspection of the contents.

• Can withstand high temperatures and sterilization processes.

• Recyclable and environmentally friendly.

2. Tertiary Packaging

• Used for bulk transportation and storage of pharmaceutical products.

• Includes crates, pallets, and shrink wraps.

• Protects products from mechanical damage during shipping.

• Ensures safe handling and efficient distribution.

3. Emulsifying Agents

• Substances that stabilize emulsions by reducing surface tension between

oil and water phases.

• Examples:

o Natural: Acacia, Lecithin

o Synthetic: Tweens (Polysorbates), Spans (Sorbitan esters)

o Finely Divided Solids: Bentonite, Magnesium hydroxide

4. Polyethylene Glycol (PEG)

• A water-soluble polymer used as a solvent, plasticizer, and base in

pharmaceutical formulations.

• Acts as an osmotic agent in laxatives.

• Enhances drug solubility and stability.

• Commonly used in ointments, suppositories, and parenteral

preparations.

5. Types of Problems in Optimization

• Linear vs. Non-linear Optimization – Based on the mathematical nature

of the problem.
 • Single-objective vs. Multi-objective Optimization – Whether optimizing
one or multiple goals.

• Constrained vs. Unconstrained Optimization – Presence of restrictions

in the solution space.

• Deterministic vs. Stochastic Optimization – Whether variables are

known or have uncertainty.

6. Elements of Quality by Design (QbD)

• Target Product Profile (TPP) – Defines desired product characteristics.

• Critical Quality Attributes (CQA) – Properties affecting drug quality.

• Risk Assessment – Identifying and mitigating process risks.

• Design of Experiment (DoE) – Using statistical tools for process

optimization.

• Control Strategy – Ensuring consistent product quality.

7. Classification of Non-Ionic Surfactants

• Polyoxyethylene-based: Polysorbates (Tween 20, Tween 80).

• Sorbitan esters: Span 60, Span 80.

• Fatty alcohol ethoxylates: Cetomacrogol, Brij series.

• Amphiphilic block copolymers: Pluronics (Poloxamers).

8. Systemic Optimization Techniques

• Gradient Descent – Used for machine learning and numerical

optimization.

• Genetic Algorithms – Inspired by natural selection.

• Simulated Annealing – Mimics metal cooling processes for global

optimization.

• Response Surface Methodology (RSM) – Analyzes the effects of multiple

variables.

9. Applications of Optimization

• Pharmaceutical Formulation – Optimizing drug release profiles.

• Process Engineering – Reducing manufacturing costs and improving

efficiency.
 • Clinical Trials – Optimizing dosage and treatment strategies.

• Supply Chain Management – Streamlining logistics and distribution.

10. Pharmaceutical Excipients

• Inactive substances added to drug formulations to aid processing and

enhance drug delivery.

• Types:

o Binders: Starch, Polyvinylpyrrolidone (PVP).

o Disintegrants: Croscarmellose sodium, Sodium starch glycolate.

o Lubricants: Magnesium stearate, Talc.

o Preservatives: Benzalkonium chloride, Parabens.