A New Approach to Oral Drug Delivery System

Dr Anwar Daud
Managing Director
Zim Laboratories Limited
Recently, oral dispersible films are gaining interest as an alternative of orally dispersible tablets and other conventional orals. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased pat ient compl iance.Dr Anwar Daud, Managing Director, Zim Laboratories Limited, in an exclusive interaction with Mahesh Kallayil, talks about market for Thin Film Drugs in India, its advantage over traditional dosage forms and much more.

As a leading player in Thin Film Drug manufacturing, how do you see Indian market for Thin Film Drugs maturing? How do you compare it with other international markets?

The opportunity for oral dispersible films as a simple replacement for orally dispersible tablets and other conventional orals is by itself a huge opportunity considering that about 35,000 Cr of the present Indian pharmaceutical market consists of oral products with single dose less than 100mg. The simple advantage of differentiation in a crowded branded generics market facing pricing pressures coupled with "greater convenience" to the patient is likely to lead to the rapid growth of this dosage form for the next 6-9years. The intermediate to long term acceleration in growth would come from more sophisticated applications such as sub-lingual/transmucosal absorption. We have projected a rapid growth phase of the oral thin film market.

Internationally, oral thin film has developed in two different directions - in pharmaceutical segment as well as in the nutraceutical segment. Both have large potential for business and growth. The pharmaceutical segment will grow based upon the opportunity available, regulatory constraints imposed by the various licensing authorities, ability for the dosage form to serve as a non-infringing alternative to chemical entities coming off-patent and ability of the dosage form itself to enable oral sublingual and transmucosal absorption of small as well as large molecules. Secondly, there are large number of nutraceutical products available internationally.

What are the biggest bottlenecks in your view for the OTF manufacturers in India to compete at the global level? What are the challenges for Indian companies?

The technology to manufacture oral thin films is new and very few companies have developed know-how and expertise on the manufacturing process to enable consistent commercial manufacturing of products with acceptable quality. Comparatively few products are available in the market compared to the number of products which are possible. The global market for orally dissolving products is 11.40 billion USD and is expected to reach 27 billion USD by 2025.

The other big bottlenecks besides lack of available expertise are incomplete understanding of the regulatory requirements by manufacturers as well as regulators, with reference to plant, equipment, processes, establishment of Bio-Equivalence etc and risk aversion by established brand leaders large to switch their conventional products to this innovative dosage form.

The challenge for Indian companies further consist of producing differentiation through films at the same time keeping the products affordable and select the right products from view point of regulatory requirements and real patient convenience.

What are the advantages of thin film drugs as compared to traditional dosage forms?

The conventional oral solid dosage forms, like tablets and capsules and other oral forms have been used largely for adult population. However, not everybody can swallow medicines or carry or ingest them in a non-messy manner. Special patient populations like pediatric, geriatric, dysphagic, mentally challenged and the bed ridden have special needs that require an alternative to swallowing. Orally dissolving films are thin films which when kept on the tongue dissolve almost instantaneously. Unlike tablets and capsules these thin films do not require water for their administration and unlike liquids these can be easily carried in bags, pusses, wallets, etc. These films are taste masked and have very good palatability. Being a unit dose, dose uniformity can be ensured with thin films which is a problem in case of liquid medicines. Fast dissolving thin films are not only helpful for special need patient population but are also desirable by other groups of patients.

Going by the presence of ZIM labs in the markets for almost three decades, how has the company performed so far?

Although the company has been in existence since last several years it has kept changing with the times and requirements of the market continuously. Starting from humble beginnings in 1990 as a tiny organization of 15 people catering to the local institutional business, Zim is today a mid-sized formulation manufacturer with multiple facilities, highest accreditations, an export presence in about 50geographies and multiple business streams. The latest avatar of the organization which saw accelerated growth and achievement of niche product leadership is not more than 6-7years.

What do you see the company's competitive edge?

Zim is a process innovation company which develops various technology platforms for delivery of pharmaceutical products, resulting in product differentiation and enabling patient convenience and treatment adherence while maintaining affordability. For e.g. for several years we have been manufacturing and supplying pellets, granules, tablets, capsules etc. in sustained release, controlled release, taste masked etc. using different compositions. This enables the company to have strong capabilities in the development and manufacturing of complex generics and differentiated products. We at Zim see this as our main competitive edge in any crowded price sensitive pharmaceutical market whether domestic or international.

How does the company keep abreast with the ever-changing trends in the pharmaceutical industry?

Our passion for innovation keeps us constantly engaged with our various business partners in developing new products which are differentiated in delivery or composition. This is critical to keep abreast of new and changing technology and market requirements. In addition we also keep ourselves aware of the latest developments in pharmaceutical science and product approvals as reported in scientific journals and trade magazines, attending and networking at various workshops and conferences on different subjects of interest for our organization to gain an understanding of the latest trends and areas of work by peer companies and scientists, displaying the company's work in various trade fairs and interacting with existing and potential customers and receiving their inputs and knowledge, and finally carrying out collaborative research work with key academic resource persons to build our capabilities in cutting edge areas relevant to us.

Last year, Zim Laboratories partnered with Nagpur University in developing a new drug for treating multi-drug resistant (MDR) uropathogenic bacterial infections under Rashtriya Ucchatar Shiksha Abhiyan (RUSA)'s Research and Innovation (R & I) Project 'Technology Transfer. In this backdrop, Could we have your views on government initiatives in linking between academia, industry and government to achieve economic growth and build innovation ecosystem in India?

We have been regularly participating in such government initiatives and believe that such collaborative work can add immense value to both academic institution as well as industry by reducing the cost of innovation, making research work at Academia more relevant to society and bridging the gap between provided and required knowledge for students who will ultimately become part of the industrial eco-system. We have a track record of being one of the more successful organizations in such collaborative wor. Although the government is making a great effort in creating more linking opportunities between academia and industry, much more needs to be done in terms of tuning the interface between both to start contributing to economic growth and building innovation eco-system in India.
  • There is a need for the industry to have a deeper and earlier intervention in affairs of Academia to develop confidence that projects sponsored by them will be treated with required seriousness.
  • Further, Academia needs to make fundamental changes in its working and policies to incentivize the researchers including faculty to undertake meaningful work which will create value in the market place.
  • Also, industry needs to be a motivated partner for working with academia by the government proposing various tax and other incentives to compensate for the time and resources deployed by the industry.
  • Finally, as innovation cannot exist in isolation efforts are needed for various inter-disciplinary universities and colleges to be geographically placed in proximity of each other as well as various industrial research facilities as is found elsewhere.
What is your view on the government's 'Make in India' initiative? As a top player in OTF manufacturing, how you think this initiative catapulted India into top manufacturing economies? What, according to you, are key hurdles in the path of 'Make in India' initiatives?

The government's Make in India initiative is a strong step in the right direction, as it will help in building India into a modern industrial power capable of absorbing our youth into the right jobs and career which will suit their ability and ambitions. This has the potential to certainly catapult India into becoming a top manufacturing economy. The key hurdles are:
  • Education and training system which makes youth directly employable
  • Changing of culture with reference to professionalism incorporate management and attitude towards work discipline, following processes and systems which lead to international quality products.
  • Policies which favor and reward investment in innovation and in ease of doing business.
  • Funding avenues for first generation entrepreneurs and a social and regulatory framework which "allows to fail".
Although the government has taken several positive steps, more steps are definitely welcome going forward to address above.

Kindly outline the future roadmap for your company? What are the new business domains you are foraying into?

Zim sees itself as a process innovation company creating several technology platforms going forward aimed at addressing patient convenience and adherence. The future trends favoring highly potent generic medicines and large molecule & biological formulations require new and novel modes of administration. The trend towards multi-busters and customized medicines is very interesting opportunities for any pharmaceutical formulation process innovator and we intend to develop further capabilities to meet these requirements through co-development partnerships.

In the near future, Zim has plans of leveraging its current capabilities, in development, manufacturing and supply of various generic products under different dosage forms to increase its geographical foot print in the emerging markets both as semi-finished and finished formulations.

It also has plans to enter the regulated markets in next three years - particularly with the Oral Thin Film technology in partnership with leading marketing companies. We also intend to leverage our formulation development capabilities to enter the codevelopment and out-licensing business as well as the Nutraceutical market.