PharmaTutor l For Pharmaceutical Industry & Pharma Student

                                          Top 10 Pharma Industry Trends & Innovations in 2021 The COVID pandemic has forced all companies to rethink many aspects of their business, including manufacturing and the same holds true for pharma companies. The pandemic also highlights the need for improving the speed and accuracy of finding and mass-producing novel drugs, treatment methods, and vaccines to respond to such large-scale and high-pressure demand. Below are most relevant solution  1. Artificial Intelligence and Machine Learning The use of artificial intelligence and machine learning is accelerating the drug discovery and development processes. Pharma industries are exploring the use of these technologies to address the various challenges, such as automation and optimization of the manufacturing processes, as well as designing effective marketing and post-launch strategies. Patient identification is a crucial step in the drug discovery and development process, especia

                                     Nitrosamine Impurities: API & Pharmaceutical Products The Sartans case substantiates the necessity for the pharmaceutical industry to improve the standards on application of risks management tools, particularly regarding post approval activities. The case also showed some of the potential risks associated with the lack of transparency between MAHs, API manufacturers, and others over patient safety and the shift required to increase transparency through revisions of the regulatory framework whilst ensuring safeguarding of confidential information.   Medicine regulatory authorities were alerted of the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is an Angiotensin II Receptor Blocker (ARB) belonging to a class of products commonly referred to as sartans. The medicines containing valsartan API were immediately recalled, and a regulatory review was triggered in accorda

                                          Continuous Manufacturing- Improve Manufacturing Efficiencies: A Generic Industry Perspective   Continuous Manufacturing The conversion of batch processes to continuous manufacturing is the future of the pharmaceutical industry, employing the continuous flow, end-to-end integration of manufacturing sub-processes with a significant level of control strategies. The benefits of continuous manufacturing over traditional batch processes are evident, but the implementation is still at snail speed. The pharmaceutical industry is acknowledging continuous manufacturing as an option to improve and sustain manufacturing operations. The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies. Lean concept can play a vital role to eliminate wastes and to design the continuous manufacturing process.   Role of Continuous Manufactu

                                                              Pharmaceutical  D eformulation / Reverse Engineering of a Product’s Formulation   Step 5: Formulation and process development… Cont….   https://pharmatutor21.blogspot.com/2021/02/generic-product-development-key-steps-l_7.html Understanding of RLD product:   Understanding of information available in ‘Label’ section The PIL/Label will provide the information regarding the qualitative composition of the formulation. In this case qualitative formulation of Table and Oral Solution. Let us explore the Tablet formulation.               Step-1:              From the PIL, we can get the information                  1.      Strength: abacavir sulfate equivalent to 300 mg of abacavir 2.      Active pharmaceutical ingredient: Abacavir [available as a salt form] 3.      Inactive ingredients: (i) Microcrystalline cellulose (MCC), (ii) Sodium starch glycolate (SSG), (iii) Colloidal silicon dioxide and (iv) Magnesium steara

                                               Generic Product Development Key steps Cont….  A typical product development process can be classified as below Step 1: Discovery (Product Idea) Step 2: Product Definition Step 3: Business Case Development Step 4: Project feasibility For Step 1 to step 4, refer link  https://pharmatutor21.blogspot.com/2021/02/generic-product-development-key-steps-l.html Step 5: Formulation and process development Step 6: Pilot Bioequivalence Study Step 7: Submission / Validation Batch Manufacturing Step 8: Pivotal Bioequivalence Study Step 9: Dossier Filling Step 10: Post Dossier Filling Step 11: Commercial Launch Step 12: Post approval Changes/ Life Cycle Management     Step 5: Formulation and process development A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Therefore, understanding of innovator product is very much essent