The Society for Pharmaceutical Dissolution Science (SPDS) has lined up a number of programmes in 2016 including the Disso Europe 2016 in Turkey and Disso Indian 2016 at Ahmadabad, according to Vijay Kshirsagar, president of SPDS & CEO and director of TRAC consulting, Mumbai.
Stressing that the objective of the society is to spread the knowledge of dissolution science so that the products that are developed here have a good invitro/invivo correlation, Kshirsagar also informed that the immediate next programme in June 2016 is on Quality by Design (QbD) in dissolution.
SPDS which was formed just five years back has gained international presence and acceptance in a short span of time, he added.
Kshirsagar was speaking to Pharmabiz at the sidelines of a course on Automation in Dissolution Testing & Dissolution Studies for Novel Drug Delivery Systems, in Mumbai, recently organised by the SPDS in association with Institute of Chemical Technology (ICT).
This course was fourth of the Professional Development Certification Course Series entitled "Pharmaceutical Drug Development Process: Role of Dissolution Testing" launched by SPDS in June 2015.
Dr Milind Joshi, president- global quality affairs, J BChemicals & Pharmaceuticals, Mumbai, who presided the function as the chief guest, emphasised on the need to have a robust product testing in the first stage in dissolution. Pointing out that programmes like this are very few in the industry, he said that SPDS should take up this as an in-house programme to benefit larger number of professionals.
Dr L Ramaswamy, general secretary of SPDS & managing director of Sotax India stressed the need and importance of lab automation and its benefits to the companies and analytical scientists.
Automation helps to remove human errors and do the test in the same manner repeatedly any number of times, he pointed out.
The programme was designed and executed by Michel Magnier, product manager & application specialist in dissolution testing from Sotax AG, Switzerland and Sameer Haddouchi, managing director, SPS Pharma, France who are international experts on the subject.
The programme chair was Dr Padma Devarajan, Professor, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology.
The course was specifically designed for scientists from R&D, QA & QC responsible for automation & dissolution testing of NDDS, project heads responsible for automation of labs, managers/analysts and chemists, students, PhD scholars and faculty from pharmacy colleges, regulators.
This workshop was conducted to present a comprehensive mass of critical information to the R&D (formulation and analytical), QC/QA and PK professionals to help them in defining what level of automation they may require. Through a step- by -step evaluation of the attendees, complete dissolution process (dosage forms, method, workload, & analytical requirements) and the various solutions to eliminate them were discussed.
During the programme, Michel Magnier explained that automation enhances efficiency and therefore impact the laboratory workload positively by showing examples of ROI calculation on dissolution automation.
Samir Haddouchi discussed current and new applications related to the USP Apparatus 4. During the programme, the flexibility and ability of USP4 -Flow through cell apparatus to characterize the release properties of a wide variety of formulations and how it is a powerful tool for pharmaceutical development have been discussed.
The highlight of this course was the experience shared by users of automation and USP4 apparatus who are eminent professionals from pharmaceutical industry and academia like Dr Narasimhan Kasthurikrishnan, director- Clinical Release and Stability Group, PDMS- AD Johnson & Johnson, Maheswara Reddy, associate director-ARD, Dr Reddy's laboratories, Hyderabad and Prof Mala Menon, Professor, Bombay College of Pharmacy.