Usha Sharma – Mumbai
A conference on Innovations in Formulation and Drug Delivery was recently held in Mumbai. The two-day long event focused on improving drug performance and therapeutic impact through enabled formulations and more effective delivery methods. Various innovation techniques in pharma formulations were discussed during the conference.
Prof Ambikanandan Misra, Professor of Pharmacy, MSU, David Sadler, President and CEO, Zotek KL, Dr Vinod P Shah, Pharmaceutical Consultant, Former US FDA, Dr Devaraj Rambhau, Technical Director, Pulse Pharma, Dr Saeed Qureshi, Principal, PharmacoMechanics, Dr Rajan Verma, Associate Director, Perrigo, Dr Muhaned AI- Hindawi, Former Senior Pharmaceutical Assessor, MHRA, Dr Saranjit Singh, Head of the Department of Pharmaceutical Analysis, NIPER and Babus KS, Head Regulatory, Hospira, A Pfizer company, were the key speakers at the event.
Shah talked about the importance of dissolution studies in alcohol. As in many developed countries, people are likely to consume alcohol after taking medicines. He also informed that this study has been recently introduced by regulators.
While talking about the biopharma classification system, he mentioned that it is a drug development tool to justify biowaivers in conjunction with the dissolution of the drug product. In the US, the highest strength of pH is taken for solubility study, whereas the same is not the case in Europe. He also informed about the genesis of biowaiver monographs and mentioned that so far, more than 45 biowaivers monographs ranging from BCS class 1-4 have been generated. These have been prepared and published in J Pharma Science and are available on the FIP web page. The project was initiated by the International Pharmaceutical Federation interest group.
Rambhau shared technical information about the application of nanotechnology in formulation of oral dosages. He feels that nano-enabled drug delivery system will be the only way forward for developing countries like India. In his presentation, he touched upon regulatory guidelines for nanosimilars and nanogenerics. He also emphasised that nanoparticles require intense high tech instruments and no regulator will allow companies to conduct a test without or less competence of this.
Qureshi delivered a detailed note on developing and validating discriminatory drug dissolution test and profiles. He asked the audience to explain what is a discriminated test and how to conduct discriminated dissolution tests? He informed that a drug dissolution test is conducted to assess drug release characteristic of tablets/ capsules.
Verma talked about the 505 (b) (2) approval pathway considering NDAs, 21 CFR 314.108 and 314.108 exclusivity.
A workshop was also organised on the second day of the conference.