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Formulation Development Study

What topics should be prioritised as a formulation development scientist?

As a formulation development scientist you should have good understanding on below topics (but not limited to):

1. Polymorphism & solubility of API

https://www.researchgate.net/publication/336210788_Polymorphism_and_Crystallization_of_Active_Pharmaceutical_Ingredients_APIs

2. Biopharmaceutics Classification

https://www.pharmaspecialists.com/2021/08/bcs-classification-of-dugs.html

3. Choice of excipients

https://www.pharmaspecialists.com/2023/01/choice-of-excipient-and-its-grade.html

4. API-Excipient compatibility study

https://pharmadigests.com/drug-excipient-compatibility-study-during-qbd/

5. RLD/RS characterization/Reverse engineering

https://www.pharmaspecialists.com/2021/11/pharmaceutical-rld-or-rs.html

6. FDA dissolution method database

https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm

7. FDA inactive ingredient database

https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

8. Dissolution profile

https://www.pharmaspecialists.com/2022/12/comparative-dissolution-profile.html

9. Stress/Force degradation study

https://www.pharmaspecialists.com/2022/07/forced-degradation-studies.html

10. Stability study

https://pharmadigests.com/stability-data-and-evaluation-of-finished-pharmaceutical-products/

11. Shelf- life Calculation

https://www.pharmacalculation.com/2023/01/shelf-life-calculation-of-drug-product.html

12. Impurities & Residual solvents

https://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products-scientific-guideline

https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline

13. QbD tools & DoE

https://pharmadigests.com/pharmaceutical-quality-by-design-tools/

https://pharmadigests.com/design-of-experiments-doe-in-drug-formulation-development/

14. Process optimization and validation

https://www.pharmaspecialists.com/2022/04/process-optimization-of-pharmaceutical-products.html

https://industrialpharmacist.com/2023/09/process-validation-in-pharmaceutical-industry/

15. BE study and strategy

https://www.pharmaspecialists.com/2024/06/bioequivalence-be-in-anda-filing.html

16. SUPAC Guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ir-immediate-release-solid-oral-dosage-forms-scale-and-post-approval-changes-chemistry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-mr-modified-release-solid-oral-dosage-forms-scale-and-postapproval-changes-chemistry

17. ANDA

https://www.pharmaspecialists.com/2022/01/generic-drug-approval-process.html

18. Patent & Exclusivity

https://www.pharmaspecialists.com/2022/07/intellectual-property-rights-in-pharmaceutical-industry.html

19. 21 CFR Part 211

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

20. Tablet problem & remedies

https://www.pharmaspecialists.com/2022/08/common-tablet-defects-and-remedies.html