The Society for Pharmaceutical Dissolution Science (SPDS), registered at Mumbai and having its own chapters at South and North of India , is engaged in helping the pharmaceutical industry and contract research labs (CROs) maximize the benefits of dissolution methodology and drug testing.
The basic purpose of SPDS is to update the developments in the field of dissolution science and its application. Towards this end, the Society organises seminars associating the pharmaceutical industry scientists, pharmacy college faculties, students, analytical instrument manufacturers to help keep pace with the advances. The equipment manufacturers and software companies view it as a platform to demonstrate the advanced versions, says Dr. L Ramaswamy, Managing Director, Sotax India Pvt. Ltd, and General Secretary, Society for Pharmaceutical Dissolution Science .
Such events provide a framework for participants to move forward in an era of mandatory Good Laboratory Practices. For instance, Switzerland-based Sotax demonstrated the USP IV flow through cell which is a unique instrument where many difficult form of formulation can be tested. Since SPDS is the only of its kind in the world, there is a good attraction to participate in its events, he added.
Going forward,the SPDS South Chapter will actively work with the special interest groups in the area of dissolution from both academia and industry with an objective to spread the importance of drug testing and dissolution studies, said Dr. Ramaswamy.
In the wake of a few US FDA 483 issuances for Indian pharma and concerns by the global regulator over quality of our drugs marketed and the manufacturing practices, the Society which mainly focuses on the dissolution science and application could suggest improvement of method development by application of QBD. This will ensure methods becomes highly discriminative with proper ruggedness and validated status. Further it can contribute to knowledge sharing and a platform to discuss and debate the challenges and issues in drug testing methods and specification, said Dr. H.V.Raghynandan, Associate Prof. JSS College of Pharmacy, JSS University, Mysore and General Secretary-SPDS( South Chapter)
Current scene of dissolution science in Indian pharma
Dissolution science is an important branch of analytical science. Pharma industry cannot afford to ignore this component in GLP because dissolution science indicates the drug absorption in the body and its action.
Currently most companies carry out the dissolution test manually or using semi-automatic instruments . These include both national and international companies like Sotax, Erweka, Distek and Electrolab, to name a few.
The trend is moving towards fully automatic dissolution tests where in there is just a need to drop a tablet or capsule to generate the required result. Sotax is the pioneer in this field of dissolution automation .
India is at a relatively advanced stage in the area of dissolution methodology. In terms of instrumentation, the country imports only a mere 20 per cent and 80 per cent of the manufacture is indigenised. Companies have the expertise to manufacture these instruments. However, it is only the fully and semi automatic systems that are sourced from abroad. The automated systems are backed by detailed systematic recording of all the operation and in process controls. The precision, accuracy and reproducibility of the results are excellent. It decreases human error as very few variables are required to run the automated instruments.
Visible trends in India and international markets
In India, the use of USP 1 &2 method are widespread. However with the introduction of USP IV, companies are seen switching over to ‘flow-through-cell’ method (USP IV) for poorly soluble compounds, SR/MR forms , powders, stents, microspheres, nano particles, depot preparations, suppository tablet testing.
Another trend seen is a shift from manual testing to semi automatics testing and then adopting fully automatic testing to avoid all possible human errors.
The range of sophisticated content testing instruments have improved productivity. It is also seen to perform fully automated sample preparation and analysis for the most common pharmaceutical tests in the development and quality assurance laboratories.
In the wake of the global slowdown there has been no impact on the dissolution methodology instrumentation industry which is seen to be registering a steady growth, said Dr. Ramaswamy.
Sotax being the pioneer in USP IV has garnered 95 per cent of the market share in the segment of Flow through cell systems installed in India.
SPDS shall join hands with instruments manufacturers who have demo lab where the dissolution instruments are displayed and the facility is accessed by industry professionals, research scientists, pharmacy college staff and students to witness the demonstration and have hands- on training with the instruments, said Dr. Ramaswamy.