Theory, Practice and Technology:

Pharmaceutical R&D and

Manufacturing for Drug Products


A Generic Manufacturers Guide
























Contents

1. How Drug Innovator does its drug product development after discovery
2. Overview of API bulk Drug Synthesis and implications to Drug Product
Formulation and Manufacturing
a. QbD approaches
b. Crystallization Process, Crystal Form Design
c. Understanding Polymorphism
3. Market Review
a. Batch size and volume estimation, prediction
4. Literature Review
a. Understanding clinical trials
b. Scientific Journals and Patents
5. API and excipient characterization, identification and screening
6. New approaches to product stablity tests, shelf-life determination,
stress tests
a. New models for simulating drug degradation reactions
b. Revisiting Drug degradation reactions: Reviewing organic
chemistry and reactions, chemical kinetics and kinetic modelling
c. Neglected physical changes on drug substance and products
7. Solid Dosages Formulation
a. IR Tablets, capsules
b. BCS (Biopharmaceutical Classification System)
c. Polymers, gums, resins, macrmolecules and surfactants for
pharmaceutical formulations
d. Sustained/ Controlled Release
i. What new SR/CR product can you launch in the market next
year?
e. Liposomal drug delivery
f. Amorphous APIs
g. Microencapsulation: What is possible and what is not
h. Simulating dissolution profiles
8. Dispersed Systems Formulation
a. Softgels
i. Formulation, technology and manufacturing
ii. Sample plant, equipment and process design
iii. Sample manufacturing process, product specifications
iv. Typical problems and solutions
b. Syrups and suspensions
i. Stable suspensions
ii. Solutions including challenges and problems in formulating
beverages
9. Process Development, A Process Engineering Approach
a. Process simulations, calculations, rules-of-thumb, new
approaches (QbD)
i. Granulation, spray and mixing
ii. Dry powder mixing
iii. In-vivo/in-vitro correlations
b. Scale-up work
c. Managing and maintenance of process equipment, piping,
instruments, toolings etc.
10. Nutraceuticals
a. Differentiation with respect to efficacy and bioavailability: how to
have a competitive advantage over products without therapeutic
effect
b. Product development with nutraceuticals
i. Pro, pre, synbiotics
ii. Superfoods
c. Case studies
11. Biopharmaeuticals
a. Recombinant DNA Production
b. Develoment of biosimilar products
c. Formulation, process development
d. Equipment, Plant and Process design of a biopharamceutical,
sterile injection plant facility
i. Differences, difficulties and challenges as compared to solid
dosages plant
e. Insulin
i. Manufacturing and production of insulin
ii. The failed Inhaled insulin
f. Mabs
g. Hormones
h. Interferons
i. Antigens
j. Viral vaccines
k. Challenges in incorporating big molecule active raw materials into
secondary processing
l. Case studies