In general, can you tell us about the oral solid dosage services and expertise Recipharm offers to the pharmaceutical industry?
Recipharm has extensive experience developing and manufacturing most types of oral solid dosage (OSD) forms, including:
- Coated and uncoated tablets
- Bi-layer tablets
- Mini tablets
- Hard Capsules (conventional and multi dosing)
- Granules and powders
The company has the expertise and capability to work with formulations for new chemical entities (NCEs), improve products with existing drug substances, development of generics, and support all phases of clinical development. Recipharm offers a range of manufacturing capabilities to meet the specific needs of any product, from wet or fluid-bed granulation to direct compression and coating.
The company specializes in formulating modified release (MR) products and fixed-dose combinations (FDC), allowing drug developers to offer robust OSD products that offer greater therapeutic effect and patient convenience.
Recipharm’s dedicated technology transfer teams ensure smooth scale-up and transfer into commercial manufacturing, regardless of the nature of the OSD project.
What are some of the most pressing industry issues facing companies that are developing oral solid dosage products?
Three key challenges are impacting pharmaceutical companies and changing the OSD landscape:
- Meeting patient demands for more convenient drug products - The need for careful consideration of patient experience is more important than ever in a competitive market. The texture, shape, and scale of the OSD, as well as taste, can be adapted and optimized to address patient adherence requirements, as they enable ease of administration for patients who may have difficulty ingesting pills.
- The desire of oral biologic treatments and the related challenges compared to conventional oral solids - Traditionally, biologics have had to be delivered parenterally. Recent developments are making OSD biologics increasingly viable, with the potential to make a range of biopharma treatments self-administered, enhancing patient convenience while reducing the burden on healthcare providers. To make oral delivery an effective alternative to injection though, biologic OSD forms will require new formulations, different production processes and solutions for solubility, absorption, and stability challenges.
- The growth of orphan diseases - The global rare disease market is growing rapidly, posing challenges for drug developers, due to their small-batch manufacturing requirements. New commercial paradigms are required to make them financially viable. 3D printing of OSD forms is one option that drug developers are increasingly considering as a means of manufacturing small batches of these medicines as cost-effectively as possible.
What is Recipharm’s approach to mitigating oral solid dosage development and manufacturing problems? What resources and expertise can the company leverage to solve these issues?
Recipharm offers extensive resources and expertise to support pharma companies in overcoming the challenges thrown up by these developments in the OSD space:
- Leveraging data science, digital technology and statistical models to enable data driven, informed decisions, to fully understand the CMAs, CPPs and their impact on the Quality Attributes and to cut timelines and to reduce API amount needed for development.
- Addressing formulation challenges - Recipharm offers dedicated analytical and formulation development expertise. It has resources and capabilities to analyze the physical/ powder characteristics of the API, such as particle size, morphology, and solubility. It can support excipient selection and the development of the final manufacturing process to make an OSD approach viable for the molecule.
- Specialist infrastructure and capacity - Recipharm offers dedicated production lines for manufacturing a wide range of OSD forms, providing drug developers with instant and easy access to the infrastructure and the capacity they need to meet their project requirements without the need for them to invest themselves.
- Expert regulatory support - Regulatory submissions for new drug formulations must be able to show that issues such as solubility and bioavailability, as well as API stability have been addressed to ensure optimum therapeutic performance - a particular challenge for OSD forms. Recipharm can support drug developers in defining their regulatory strategy alongside their development approach to minimize the risk of delays and maximize chances of success.
Can you tell us what specifically sets Recipharm apart from other providers of oral solid dosage development and manufacturing services? Why should a sponsor choose Recipharm over another company?
Recipharm can provide integrated solutions for the development, manufacturing, packaging, and testing of pharmaceutical products.
Looking forward how do you see the pharmaceutical industry responding to oral solid dosage challenges and how will Recipharm continue to innovate to provide services to current and future clients?
The pharmaceutical industry will continue to innovate OSD formulation technologies to make oral administration available to a wider array of treatments and applications, including those harnessing large molecules, to further improve patient convenience. Recipharm is constantly exploring exciting new formulation approaches and alternative excipients to ensure it can provide clients with the support they need to deliver effective OSD products.
Drug developers and their supply chain partners, including contract development and manufacturing organizations (CDMOs) will continue to invest in cutting-edge technology to enhance the financial viability of personalized medicines and rare disease treatments.
Finally, we will continue to see strong demand for OSD manufacturing into the future, and for flexible infrastructure capable of supporting new dosage forms. Recipharm is constantly investing in its capabilities to provide clients with the flexible and specialist capacity they need to meet their evolving OSD manufacturing needs.
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