The importance of the dissolution rate on the clinical performance of drugs and drug delivery systems is a critical component in the drug development process. Dissolution testing can be carried out on either tablets or capsules. The test is more often performed on products that are known for absorption problems and poor solubility, said Dr BR Jagashetty, Karnataka Drugs Controller and president, IPA, Karnataka.
Although the US Pharmacopoeia has set standards for tablet integration testing and for dissolution, often the suggested procedures are modified by the manufacturer to meet the specific needs of the problems related to poor solubility, Dr Jagashetty said in this key note address at the two day seminar organized by IPA Karnataka in Bangalore.
The key objective of the dissolution testing is to provide the patient a consistent therapy. This requires that the dosage forms release the active ingredients in a consistent and reproducible manner. The real test is the therapeutic outcome. The dissolution rate of dosage forms and in-vitro models are unable to realistically duplicate biological conditions. The crucial test of any in-vitro dissolution test model is its correlation to the in-vivo situation. To date, no dissolution test has been devised that in every instance gives the same rank order for 'in-vitro' dissolution and 'in-vivo' availability for different formulations or batches of the same drug, added the Dr Jagashetty.
Dr Rashmi Barbhaiya, CEO and managing director, Advinus Therapeutics, said that the dissolution tests are a challenge for drug researchers. This is because drug interaction in the body varies from individual to individual. Further, there are also different changes in controlled and sustained release drugs.
IPA has also teamed up with American Association of Pharmaceutical Scientists saw international speakers for the event which was co-organized by Karnataka Drugs Pharmaceuticals and Manufacturers Association (KDPMA). The event, represented a cross section of the pharma industry, had experts deliberating on 'ObD and Bio Waiver' for branded drugs by Jianmei Kochling to 'Trouble shooting dissolution method transfer' Vivian A Gray, president, V A Gray Consulting, Inc, 'Challenges in the dissolution methods for generic drugs' by Dr Saji Thomas associate director of Quality Control Operations, Par Pharmaceuticals. Other speakers included Kailas Thakker, president and CEO, Analytical Solutions, Inc, G Bryan Crist, scientific affairs manager, Varian, Inc, and Erika Stippler, director, US Pharmacopoeia.
Dr B Suresh, president IPA was the guest of honour for the event and Krishna Dev. chairman regulatory affairs, IPA and former ADC, CDCSO was also present.