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‘Dow India has multiple assets with an unmatched product mix of excipients worldwide’

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Dow Pharma and Food Solutions has recently launched an excipient, Methocel DC2, which reduces manufacturing costs and development time by 60 per cent. Savindu Kudrigikar, GM- Pharma Marketing, India, Dow Pharma & Food Solutions, discusses the outlook, defining trends, growth opportunities and new launches in an interview with Sachin Jagdale

What is the scope of growth for the pharma excipient sector over the next five years? What is going to be the role of Dow India in the same?

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Savindu Kudrigikar

Over the last few years India has been an important hub for pharma developments. By virtue of this, the industry here has been a seat for excipient usage and development as well. Various innovative delivery systems are being explored by pharma companies and the need for innovative and performance excipients is on the rise. India is known for its quick adaptability to new excipients and associated technologies.

Pharma excipients, which serve various therapeutic-enhancing purposes such as facilitating drug absorption or solubility, are being highly valued by the pharma industry and by the world’s regulatory bodies, including the FDA and the European Medicines Agency.

Dow India has multiple assets with an unmatched product mix of excipients worldwide and can effectively service and growth with the Indian market.

Dow Pharma and Food Solutions (DP&FS) business, growing at a CAGR of 19 per cent, has doubled its presence in the Indian market over the last four years. Dow India, participates in the oral drug-delivery system – immediate release and controlled release formulations market. Globally, the company holds five of the top 10 excipient chemistries applied to a total functional excipients market which are valued at $4.4 billion.

Dow innovates along the value chain to advance human progress. Our portfolio includes, solutions to improve the synthesis and purity of active ingredients, active pharmaceutical ingredient (APIs) to help pharma manufacturers provide safe and trusted treatment alternatives and solutions and formulation expertise to help customers tackle global industry challenges, finding the right solutions to enable the formulation and release of drugs in safe, more effective and user-friendly ways.

Over the years, we have provided solutions for sustained release, polymorphism, taste masking of APIs which were being actively sought by the pharma industry. We are also focused on some of the emerging needs of pharma industry like API solubilisation and are confident of leveraging our global expertise to offer suitable solutions.

Dow India is constantly looking at mirroring its global capabilities of innovation and customer-centric application research for the Indian market. This includes building a knowledge base with the customer, bridging demand and supply gaps based on an understanding customer needs and providing with relevant solutions. We have always been at the fore-front of collaboration with customers for delivering innovative solutions that make a difference to healthcare industry.

What is Dow India’s arrangement with Colorcon and the control release alliance?

Since July 2007, Colorcon and Dow Pharma & Food Solutions formed a global Controlled Release Alliance bringing joint resource to accelerate pharma product development efforts and reach market throughout the world.

Colorcon has exclusive, global sales and distribution rights for the following Dow Pharma & Food Solutions’ products used in controlled release applications: METHOCEL Premium hydroxypropyl methylcellulose (HPMC), ETHOCEL Premium Ethylcellulose Polymers and POLYOX Water Soluble Resins.

How is the alliance likely to benefit the Indian pharma market in the coming years?

The Dow-Colorcon CR alliance offers high quality products and continuously investigates new applications to help pharma and nutritional supplement companies develop robust solid dose formulations. We are connected to our customers through an extensive network of technical service managers, the Dow-Colorcon Control release alliance listens closely to customer needs and develops creative solutions to formulation problems.

Through the use of our fully-formulated products, Dow-Colorcon CR alliance offers pharma companies cost-effective, high quality products with advanced performance and appearance. With our comprehensive range of formulation and process expertise, we are able to assist customers anywhere in the world to help them meet their solid oral dosage manufacturing goal. Knowing how time-to-market influences success, we help our customers complete their projects from product concept through formulation development to final production in reduced time frames. To enhance the use of alliance products, our services are available on site at customers’ facilities or in one of our conveniently located laboratories around the world like:

  • Formulation development
  • Concept/ Feasibility testing
  • Process optimisation
  • Tablet Design – Brand Enhancement

ETHOCEL, METHOCEL and POLYOX polymers offer an outstanding range of controlled release properties for a variety of dosage forms and processing methods. Variations in molecular weights and chemical substitutions provide multiple ways to optimise formulation performance. Each range has fundamentally different hydrophilicity, swelling and erosion characteristics, to provide flexibility in control of the main mechanisms of release.

Dow & Colorcon’s regulatory affairs and quality departments work closely together to stay up-to-date on all regulatory changes that affect the components used in formulating our products. Our global regulatory affairs group can also guide clients in selecting the right product to meet their application and target market.

The Dow & Colorcon pharma training programmes deliver the latest on coating technology and formulation. Focusing on theory and practical application, the Control Release Alliance’s educational programmes provide pharma scientists with knowledge on film coating, core formulation and controlled release.

Dow & Colorcon are actively involved in independent research at leading universities around the world. These studies can provide new directions in product technology for the pharma industry. In addition, we sponsor and participate in education courses, seminars, and symposia throughout the industry.

What is Methocel DC2 and how will it revolutionise the pharma market?

There is an industry-wide shift from batch based to continuous processing such as roller compaction a continuous dry granulation technique. Dry granulation involves less production steps than wet granulation, thus improving efficiency and reducing production costs. Avoiding degradation of moisture-labile or heat-sensitive APIs may be another reason for the paradigm shift. Direct compression is the ideal continuous processing option because all granulation steps would be eliminated, further simplifying the manufacturing process.

Through significant improved flow, METHOCEL DC2 product family, enabled by Dow’s patented Designed Particles Morphology (DPM) Technology helps customers enjoy the benefits of dry powder processing techniques while improving tablet quality and delivering the controlled release performance expected from the proven family of METHOCEL excipients.

Direct compression reduces waste and shortens the development time and manufacturing costs by 60 per cent. This polymer is particularly helpful in manufacturing of heat sensitive and moisture sensitive drugs as the wetting and drying steps are eliminated. It also restricts the additional dosage that is added to cope with the loss of viable drug due to the wetting/drying process.

Tablets made with METHOCEL DC2 assayed at 96 per cent of the expected API content. The polymer also increases the productivity (reducing steps and raw materials) and decreases the energy utilised in carrying out the operation of manufacturing a tablet. Across the industry, tablets are manufactured in batches – a process that the industry is trying to do away with for a while to get a streamlined and continuous operation. The addition of METHOCEL DC2 also helps in reduction of bottlenecks.

A polymer from the same family METHOCEL VLV has been instrumental in reducing the cycle time of the coating operation of the tablets by about 30 per cent.

Tell us about the cost effectiveness of METHOCEL DC2.

Designed to help the pharma industry shorten development time and lower manufacturing costs, METHOCEL DC2 supports pharma manufactures looking to switch to roller compaction and direct compression for matrix tablet applications.

METHOCEL DC2 will help manufacturers replace wet granulation in matrix tablet production, lowering manufacturing costs by as much as 60 per cent, reducing waste, and shortening development time. Furthermore, direct compression methods offer better formulation options for heat- and moisture-sensitive APIs.

Indian generic pharma companies have strong product development skills and have set up world-class active pharma ingredients (API) and formulation manufacturing facilities to cater to the price-sensitive India market and global generics market. Many of these dominate India’s domestic market through a large sales team, strong relations with physicians and medical institutions. METHOCEL DC2 is designed to help support their competitiveness.

Indian pharma companies are now seeking to move up the value chain to drug discovery and development by leveraging the country’s scientific talent. Given the strengths of Indian and global pharma companies, it makes sense for them to come together to develop India’s domestic market, source products for global market and to discover and develop new drugs and therapies.

Who are your pharma clients in India for Methocel DC2?

We work with the all the leading pharma companies in India.

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