Sophisticated solid dose formulations for fixed dose combinations – Jean-François Hilaire, Recipharm, explains how CDMOs can help optimise time-to-market
Demanding situation: There is an increasing demand for capabilities that support the formulation and development of fixed-dose combination drugs, says Recipharm
The solid dose market is looking healthy with strong prospects for continued growth. The market faces multiple challenges yet offers opportunities to CDMOs with advanced scientific and technological skills and can provide customers with solutions.
One of these challenges is the increasing demand for capabilities that support the formulation and development of fixed-dose combination drugs. This need is being fuelled by the mounting pressure on pharma to find ways of differentiating their branded products in the market place. Whether it’s virtual pharma companies out to establish a niche product with a strong differentiator, Big Pharma that wants to add novel products to its pipelines or established pharma companies that want to extend lines and diversify their brands – they are the impetus bringing products to market. Consequently, proactive testing and monitoring of interaction between various APIs is increasingly leading to findings showing it is safer and feasible for certain active pharma ingredients to be successfully mixed together as one fixed-dose combination.
As a result CDMOs with advanced technical expertise plus technologies and facilities that are suitable to this specialist market are in demand.
These novel and exciting fixed-dose combination products fall in to a special category of their own, offering several common APIs incorporated together into a proprietary formulation.
One such example of this is RHB-105 The product is a proprietary fixed-dose oral combination therapy, owned by RedHill Pharma. It comprises two antibiotics (amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole), combined into an all-in-one oral capsule. It has a planned indication for treatment of H. pylori infection – a product that has successfully met its primary endpoint in its first Phase III study. This shows the higher efficacy and safety of the three components when combined into this particular fixed-dose drug – proving that the new combined product is more reliable its predecessor. This product will benefit from a fasttrack review status from the FDA, as well as strong regulatory protection in place as a stamp of approval bearing testament to its medical value to the patient.
Recipharm has partnered with Redhill on this product. Developing the formulation and meeting the complex production demands for such drugs requires sophisticated formulation skills. It also demands development and manufacturing expertise, combined with the implementation of a highly integrated solution across three FDA approved sites – each with their own specialist manufacturing capabilities. Recipharm’s Fontaine and Pessac sites are manufacturing the omeprazole mini-tablets; in Strängnäs we have devoted further to encapsulating and packaging the finished product ready for final release.
There is especially strong demand from customers for CDMOs to work on modified release and fixed-dose products. With fixed dosage combination, CDMOs need the skills and development capabilities to prepare the pharmaceutical part of the regulatory submissions in accordance with the expectations of various authorities – with the goal of getting the submissions to the regulatory authorities as early as possible.
Producing these products also further heightens the growing market and customer demand for CDMOs to develop the capability to provide one-stop-shop solutions – carrying out everything from formulation and development, clinical supply and then full commercial-scale product manufacturing. First they need to redesign the formulation then enact full redevelopment of the product before carrying out the manufacturing – both initially at a clinical batch scale and then full-scale commercial supply. Contained within the full suite of services, there is an imperative need for full product resource, project management and manufacturing capabilities.
The high quality one-stop-shop CDMOs meets their customers’ need to optimise time-to-market – this includes removing redundant activities and adding additional value to the services that they provide their customers.
Significant time and resources are saved for customers who no longer have to engage with multiple partners. Moreover, there is no loss of time due to tech transfers with the seamless transition from development through to clinical batch and then on through to commercial scale manufacturing.
The ultimate aim of go-ahead one-stop-shop CDMOs is to apply continuous improvement across the supply chain of formulation, development and clinical and commercial scale manufacturing and to bring products to market in as a swift fashion as can be achieved.