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- 2. Formulation Development • Formulation development means identifying the most widely accepted form with the most bioavailability. A pharmaceutical company must also decide when, where, and how an API is delivered once a drug is taken.The formulation development process involves several stages, including. Pre- formulation studies, formulation design and evaluation, manufacturing scale-up and process development, analytical development and characterization, and stability and shelf-life determinations.Pharmaceutical formulation is a process of combining different chemical substance with the active drug to form the final Stable medical product.
- 3. Objective of Drug development • To produce a final medicinal product to produce stable drug.It must be suitable for the patient.The goal of formulation development in the pharmaceutical industry is to create a drug product that is stable, bioavailable (able to be absorbed by the body), and effective for the intended use.
- 4. Step in Formulation Development • Pre-formulation.Analytical Assay Development and Characterization.Particle Size Analysis and Characterization..Dissolution Testing.Excipient Screening.Dosage Form Development.
- 5. Pre-formulation • Preformulation is the stage of development during which the physicochemical properties of the drug substance are characterised and established. Knowledge of the relevant physiochemical and biopharmaceutical properties determines the appropriate formulation and delivery method for Pre-Clinical and Phase 1 studies. Preformulation is a group of studies that focus on the physicochemical properties of a new drug candidate that could affect the drug performance and the development of a dosage form.
- 6. Analytical Assay Development and Characterization • Analytical procedures are developed to test specific characteristics of the substances against the predefined acceptance criteria for such characteristics. Thus, analytical method development involves the evaluation and selection of the most precise assay. • Analytical development can be described as a related series of tasks where test methods are developed and qualified to support drug development phases.
- 7. Particle Size Analysis and Characterization • Particle size (PS) analysis is used to assess the particle size and particle size distribution (PSD) along with some other parameters such as zeta potential in a specimen. The application of this technique is extended to aerosols, emulsions, suspensions, and solid materials. • Particle characterization is the process of identifying various particles and grouping into categories by particle size, shape, surface properties, mechanical properties, charge properties, and microstructure. The nature of particle counting is based upon either light scattering, light obscuration, or direct imaging.
- 8. Dissolution Testing • Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. • Types of dissolution Testing • There are seven types of dissolution apparatus. We offer United States Pharmacopeia (USP) Apparatus . • Baskets • Paddles • Reciprocating cylinder • Paddle over disk • Rotating cylinder • Reciprocating disk
- 9. Excipient Screening PHARMACEUTICAL EXCIPIENTS ARE SUBSTANCES OTHER THAN THE ACTIVE PHARMACEUTICAL INGREDIENT (API) THAT HAVE BEEN APPROPRIATELY EVALUATED FOR SAFETY AND ARE INTENTIONALLY INCLUDED IN A DRUG DELIVERY SYSTEM. THE PROCESS BEGINS WITH THE IDENTIFICATION OF A DISEASE OR A THERAPEUTIC AREA WITH AN UNMET NEED. ONCE A “DRUGGABLE” TARGET IS FOUND, THE PROCESS OF DRUG SCREENING STARTS. IN DRUG SCREENING, MOLECULES THAT CAN INTERACT WITH THE TARGET AND/OR FACILITATE THE DESIRED PHENOTYPIC RESPONSE ARE IDENTIFIED.
- 10. Type of formulation • Enternal Formulation • Parenteral Formulation • Topical Formulation
- 11. Enternal Formulation • 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.
- 12. Parenteral Formulation • Available in liquid or lyophilized formUsed 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 refrigerator.
- 13. Topical formulation • Topical formulations are made up in a vehicle, or base, which may be optimised for a particular site of the body or type of skin condition. The product may be designed to be moisturising or to maximise the penetration of an active ingredient, often a medicine, into or through the skin.
- 14. Drug Development phases • Phase 1: discovery and development Phase 2: preclinical researchPhase 3: clinical researchPhase 4 clinical trialsPhase 5: FDA Post-Market Safety Monitoring:-
- 15. Phase 1: Discovery and development • 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.
- 16. Phase 2:Preclinical research • ▸ 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. • Research for a new drug begins in the laboratory. Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective.
- 17. Phase 3:Clinical research • 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.
- 18. Submission for FDA approval: New drug application (NDA) • 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.
- 19. Phase 4: Clinical trials • 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.
- 20. Phase 5: FDA Post-Market Safety Monitoring • 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.
- 21. Regulatory approval • 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.
- 22. Factors Considered During Pharmaceutical Formulations • › 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.
- 23. Conclusion • Implementation of a NPD process with stages has helped businesses focus their New Product investment on the most potentially rewarding projects.It has shortened the time between idea and revenue by orchestrating the complex set of activities required for the commercial success of new products.