Formulation development

It consists the details about the pharmaceutical formulations and development as well as new drug development.
It consists the different stages in clinical trials.
It have the details about new drug application process
ANDA
NDA
FDA APPROVAL
IND APPLICATION
CLINICAL TRIALS AND RESEARCH
New drug invention

1. PHARMACEUTICAL FORMULATION AND DEVELOPMENT By-Rajesh Kumar B.Pharm (MIT COLLEGE MEERUT)

2. FORMULATION & DEVELOPMENT PHARMACEUTICAL FORMULATION :- Pharmaceutical formulation is a process of combining different chemical substance with the active drug to form the final Stable medical product.

3. To produce a final medicinal product to produce a stable drug. And it must be suitable for the patient OBJECTIVE OF Drug Development:-

4. • Physical, chemical, and mechanical properties of drug substance • Polymorphism, solubility, pH, and particle size of drug • Inactive ingredients or excipients to be added • Effectiveness of the drug in phase I clinical trials • Results of drug stability studies . These factors are known through preformulation studies . Factors Considered During Pharmaceutical Formulations

5. • Enteral formulations • Parenteral formulations • Topical formulations . Types Of Formulations

6. o Available as capsules or tablets and Used for oral administration of the drug o Can provide rapid effect or sustained release from the digestive tract . Enteral Formulations

7. Available in liquid or lyophilized form Used for intravenous, intra-articular, intramuscular, and subcutaneous administration. Liquid form is preserved in ampoules, IV bags, vials, and prefilled syringes in refrigerators Lyophilized form is kept in dual chamber syringes, cartridges, and vials in refrigerators . Parenteral Formulations

8. Available as creams, ointments, powders or inhaling formulas . Used for skin application or nasal administration Topical Formulations

9. Phase 1: discovery and development Phase 2: preclinical research Phase 3: clinical research Phase 4 clinical trials Phase 5: FDA Post-Market Safety Monitoring :- Drug development phases :-

10. Pharma companies spend millions of dollars on research and development that includes scientific study and development of drugs for new innovation. Drug discovery is how new medications are discovered Phase 1: discovery and development

11. Preclinical research is a basic preliminary phase that involves testing the drug on animals and basic testing for safety flags. Once a lead compound is found, drug development begins with preclinical research to determine the efficacy and safety of the drug Phase 2: preclinical research

12. It generates data for discovering and verifying the Clinical, pharmacological (including pharmacodynamics and pharmacokinetic) and adverse effects with the objective of determining safety and efficacy of the new drug Phase 3: clinical research

13. When phase III clinical trials (or sometimes phase II trials) show a new drug is more effective or safer than the current treatment, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval. Submission for FDA approval: New drug application (NDA)

14. A phase 4 clinical trial begins after a drug has been approved for use in the general population following phase 1, 2 and 3 trials to rigorously test its  efficacy  and safety. Phase 4 clinical trials:-

15. There are several aspects of post-approval safety monitoring for a marketed drug. The FDA monitors all types of drug advertising for accuracy. It also monitors complaints and problems associated with a drug. It monitor the safety of drug post marketing. Phase 5: FDA Post-Market Safety Monitoring:-

16. IND Application :-IND applications are submitted to the FDA before starting clinical trials. The FDA is involved in the patent protections and generic drug transitions of all drugs. Following drug approval and manufacturing, the FDA requires drug companies to monitor the safety of its drug using the FDA adverse event reporting system (fears) database Regulatory approval

17. A definitive project plan in terms of scope, timelines and goals will help the contract service provider offer realistic cost estimates and detailed proposals. The greater the up-front communication Conclusion

18. 1. https://www.google.com/amp/s/www.news-medical.net/amp/health/what-is-a-phase-4-clinical-trial.aspx . 2. https://www.google.com/amp/s/www.nebiolab.com/drug-discovery-and-development-process/amp/ . 3. https://www.investopedia.com/articles/investing/072913/8-stages-new-drug-development.asp 4. https://www.scribbr.com/category/research-paper/ 5. https://www.slideshare.net/mobile/cognibrain1/formulation-research-and-development-services References-