‘Drug manufacturers will turn to solutions that enable decreased coating times’

Vanessa Patrao, Marketing Specialist, Dow Pharma Solutions and Savindu Kudrigikar, Business Head, South Asia, Consumer Solutions, in an interaction with Swati Rana, talk about solutions that will dominate the pharma industry in 2018

Which technologies will dominate 2018? How will they be in tune with the evolution of the pharma sector, globally and in India?

Technologies that offer functional solutions to address the industry needs for bioavailability, productivity and controlled release will dominate the pharma landscape in 2018.

Dow can help customers meet these needs with its portfolio of offerings for solubility enhancement such as Affinisol HME and SDD; for productivity such as Methocel DC2, Methocel K200M, Methocel VLV, Ethocel High Productivity and for controlled release such as Methocel CR, Ethocel and Polyox resins.

1. Solubility enhancement
   
   As the number of low solubility APIs in development pipelines and regulatory standards in APIs increases, techniques to achieve solubilisation of sparingly soluble drugs is a top priority for drug manufacturers. By recognising the importance to tailor the drug solubility enhancement polymer to the characteristics of the drug candidate and the production, market potential exists for companies to create technologies that contain more polymer tailoring options, increase manufacturing capacity, include a wider processing window and enhance solvent choice flexibility.

   The adoption of solubility enhancing polymers, such as Dow Affinisol HME and SDD to address the solubilisation performance required by insoluble APIs will be a growing trend in 2018 to address the needs of poor bioavailability. Formulated via SDD or HME, soluble polymers are effective solutions to help maintain solid stable dispersion, inhibit API crystallisation and enhance solubility in extrusion applications without plasticisers.

2. Productivity
   
   Drug formulators face increasing pressure to boost productivity as a result of healthcare cost pressure, aggressive pricing competition and the desire for process simplification. The industry-wide pressure to lower costs through higher productivity and streamlined drug manufacturing operations poses an opportunity for technologies that decrease time in formulation stage and reduces the manufacturing cost to save formulators time and money.
   To increase productivity, drug manufacturers will turn to solutions that enable decreased coating times, help further slow the release of certain active ingredients and facilitate high speed dry powder layering process for multi-particulates. Dow’s productivity-increasing excipients Methocel DC2, Methocel K200M, Methocel VLV, Ethocel High Productivity offer a seamless application in drug formulations, increasing speed to market and freeing up time for formulators to focus on other innovations.
3. Controlled release

   Lastly, the need for controlled release technologies to optimise medication performance continues to experience significant growth. As much of the new drug exploration is now based on biologics, new challenges arise from drug manufacturers as biologics contain a unique set of delivery issues with a large issue being stabilisation. Now usually only amenable to needle delivery, pharma companies who dedicate time and resources to explore delivery options for biologics and create technologies to facilitate controlled release could cause disruption in the pharma industry.

   Drug manufacturers will be drawn to companies, like Dow, which offer a one stop shop for controlled release solutions like Methocel CR, Ethocel and Polyox resins. These are versatile solutions that can be plugged into a wide range of formulations, which presents an opportunity to secure customer loyalty.

How these technologies will become solutions to help companies comply with new regulations, customer/patient expectations, etc.

Regulators have increased the amount of Good Manufacturing Practices and risk assessments for excipients in particular. For example, the European Union (EU) guideline that became effective in March 2016 for more formalised risk assessments need to be conducted on a regular basis. This shift is not limited to the EU, as we’ve seen risk assessments become more of a standard globally as a tool in managing raw material and supplier qualification.

The global supply chain is complex with regulations varying by region. Dow works with its customers to find ways to meet these regulatory challenges across multiple regions. For excipients there is particularly more diligence when they fall under drug or API regulations. For example, several countries have requirements for a specific amount of remaining shelf life for imported drug products. Since these regulations don’t distinguish excipients from APIs or the finished drug product, compliance often does not have a defined shelf life as compared to most APIs and drug products. The need for open communication between raw materials supplier and formulator is key to achieving regulatory and quality standards. This is to ensure materials suppliers not only know the drug formulation goals but also its end product use.

Consistency in meeting high product performance standards is a hallmark of quality control and meeting regulations. Dow Pharma Solutions products are backed by testing, analytics and formulation expertise to help customers create the best end use application. With each of its pharmaceutical solutions, Dow provides:

• Outstanding global technical support
• An extensive manufacturing footprint across multiple regions
• Strong business continuity for reliability of supply
• Outstanding standard of quality, consistency and manufacturing excellence
• Regulatory support including full Quality by Design sample set

Dow Pharma Solutions supports the formulation and scale-up activities to develop more robust drug formulations. Our deep understanding of the structure and property fundamentals is critical to the successful use of cellulosic polymers. With our experience in analysing chemical structures and rheology and our vast knowledge in manufacturing specialty excipients, we help you reduce development risks and support you through all stages of drug development.

What are the new launches from Dow Pharma solutions?

Dow’s differentiated solutions that address the pharma industry’s most pressing drug development challenges include:

• AFFINISOL Hypromellose Acetate Succinate (HPMCAS): Uniquely tailored to address the solubilisation performance requirements of active pharma ingredients through stable solid dispersion and inhibition of active pharmaceutical ingredient (API) crystallisation. AFFINISOL HPMC HME provides improved thermal properties conceived for hot melt extrusion. The newest grade that was launched this year is AFFINISOL HPMCAS High Productivity, its innovative properties to facilitate higher solids content for increased throughput while maintaining optimal solubility, earned the technology a nomination for CPhI’s Pharma Awards 2017.
• METHOCEL Hydroxypropyl Methylcellulose (HPMC) polymers: Water-soluble polymers that are designed to offer consistent drug release performance.
• ETHOCEL Ethylcellulose polymers: High productivity polymers optimised for dry powder layering processes that can coat 40-60 per cent faster than multi-particulate coating technologies.
• DOW CORNING topical excipients: Innovative range of topical ingredients specifically developed to facilitate patient compliance, help improve aesthetic and increase formulation flexibility.

An estimated 70 per cent of APIs present solubility issues, which can significantly limit a manufacturer’s pipeline of drug candidates. In addition to providing innovative product solutions, Dow’s Indian Engineering Center offers full formulation capabilities to help customers develop hot melt extrusion (HME) and spray dried dispersion (SDD) technologies that enhance the solubility and bioavailability of oral solid dosage forms.

[email protected]