Usha Sharma – Mumbai
Infinity Business Services (IBS) recently organised a day-long conference on ‘Innovations in Oral Drug Delivery Systems 2014’ in Mumbai. The conference highlighted latest trends and government regulatory guidelines for oral delivery in India. The event witnessed the presence of around 50 delegates from (R&D) and formulations areas.
Dr Mithilesh Trivedi, Advisor, Techno Drugs and Intermediates delivered the opening address and highlighted the need for many such seminars for the benefit of the industry and hoped that the programme would become better and bigger with time. Trivedi highlighted that in oral drug delivery, many scientific challenges and breakthrough technologies are required to generate novel dosage forms and raise drug delivery to a higher level. He also mentioned about formulations of fast dissolving tablets, highlighting the requirements for ODT and the patented technologies available in the market.
Speakers included Dr K Bangarurajan, Deputy drug Controller, Central Drugs Standard Control Organisation (CDSCO), Dr D Rambhau, Director (Technical), Nanoceutica Laboratories, Tohru Kokubo, Product Manager, Qualicaps, Dr Milind Biyani, Director, Aspire Advisors and Dr Ravindra Purohit, Director, RNP Consulting.
Bangarurajan spoke about Indian regulatory process for new drugs approval and updated industry representatives about the Drugs and Cosmetics Act besides encouraging the industry to launch new molecules in the Indian market. He also explained the various legal enactments to regulate import, manufacture and sale of drugs and briefed about the well-defined drug regulatory system under Government of India. He also touched upon requirements and guidelines for approval of clinical trials, import and manufacture of new drugs and various categories of fixed dose drug combinations (FDCs).
Rambhau explained the challenges in oral delivery of macromolecules. He presented various slides which tried to showcase issues associated with the macro molecules. In his presentation, Rambhau mentioned that heterocyclic drug era is in a slow phase of decline. There are no blockbuster drugs to be released in future. Few new molecular entities which are remaining in this category are going to be off-patent by 2015. Insolubility, resultant poor bioavailability and alarming side effects are the reasons why these molecules did not reap the best benefits. Side effects are mainly because of there distribution to the areas other than the target locus of pathology.
He explained that the hunt for efficient molecules, paid dividends and macromolecular entities such as proteins, peptides, nucleotides have been developed into potential therapeutic agents. More than 125 macromolecular entities are already approved by various regulatory agencies across the globe. Besides positive attributes like high potency and low toxicity these molecules are inflicted with delivery problems. Being macromolecules and being vulnerable for the breakdown by enzyme systems there bioavailability is the greatest limitation to unveil their full potential. It is to be hoped that even with these delivery problems these drug molecules will be ruling the therapeutic arena in future because of their high potency and low toxicity. Behind the challenges of delivery of these molecules, hidden is the greatest opportunity to exploit the full potential of these novel therapeutic agents. Continuous efforts are being centred on to find variety of solutions for the effective delivery of these drugs.
However, he was optimistic and said, “When there is a challenge definitely there is an opportunity. And when you take a challenge as an opportunity there is surety that success will follow you.” His presentation gave evidence of his teaching skills at a industry platform.
He said that today’s society is a knowledge-driven society and added, “I don’t know whether the new government will work in this area but if at all the 10 per cent work is done in the area of intellectual segment of science then certainly India will be on the top of the world as it has a capability of generating intellectuals.
Biyani, while speaking about the need for enhancing solubility and permeability enhancements, mentioned that it is most promising that absorption enhancer increases the bioavailability of poorly permeable drugs. The compounds like SLS, bile salts, cyclodextrin, chitosan, fatty acids appears to be of first choice as the permeation enhancers. Some materials/techniques can enhance solubility as well as permeability.
Purohit presented his views on hard capsules for dry powder inhalers: performance on puncturing. Purohit clarified that hard gelatin capsules with 0.25 g desiccant can be used safely so as to avoid the soggy capsules in coastal areas. The performance is not affected in arid or semi-arid regions. HPMC capsules are found to be most suitable since they are not affected by any change in moisture content. The capsule does not have the tendency to absorb moisture. He suggested that Alu-Alu packs can be evaluated for suitability since they offer best protection against moisture. However, studies need to be conducted on the in vitro performance of the product such as FPF, MMAD and GSD.