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Formulation development
- 2. PHARMACEUTICAL FORMULATION :- Pharmaceuticalformulation is a process of combining different chemical substance with the active drug to form the final Stable medical product.
- 3. To producea final medicinal product to produce a stable drug. And it must be suitable for the patient
- 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
- 5. • Enteralformulations • Parenteral formulations • Topical formulations
- 6. o Availableas capsules or tablets and Used for oral administration of the drug o Can provide rapid effect or sustained release from the digestive tract
- 7. Available inliquid 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
- 8. Available ascreams, ointments, powders or inhaling formulas . Used for skin application or nasal administration
- 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:-
- 10. Pharma companiesspend 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
- 11. Preclinical researchis 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
- 12. It generatesdata 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
- 13. When phaseIII 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.
- 14. A phase4 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.
- 15. There areseveral 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.
- 16. IND Application:-INDapplications 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
- 17. A definitiveproject 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
- 18.