Steering Complexities of Oral Solid Formulation Development and Leveraging CDMO Partnership 

Oral solid dose formulation is a complex and mature market with the most significant share i.e., about 60% of all dosage segments¹. Drug developers are constantly pressured to bring out innovative patient-centric formulations to overcome solubility and bioavailability issues, drug stability concerns, reduced or no side effects, better taste, smaller sizes for easy swallowing, etc. 

Low water solubility can substantially affect drug suspension rates in the Gastrointestinal tract, which leads to low bioavailability, ultimately triggering higher drug dosages and low patient compliance. Poorly soluble APIs require specialist technologies and excipients to overcome solubility and accompanying bioavailability challenges. Even though conventional methods such as amorphous solid dispersions or lipid-based formulations are popular with proven capabilities and commercial success, recent methods that involve size reduction to micro- and nanostructures, such as nanocrystals, nanostructured carrier systems, and microparticles are gaining traction too.  

Polymeric carriers or excipient advancements are vital in addressing API stability and shelf-life challenges. While it is crucial to assess the excipient-API compatibility, if successful, they enhance the therapeutic performance and can be used to develop controlled release drugs to provide sustained and extended therapeutic effects. For large-scale manufacturing, assuring a reliable supply chain of polymeric carriers is important.  

CDMOs and Emerging Biopharma Alliance 

Navigating the complexities of Oral Solid Dose development could be challenging for an emerging pharma company with limited commercial experience. From formulation development to manufacturing, adhering to all regulatory frameworks such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP), there are several steps to consider. Specialist partners (CDMOs) with adequate knowledge and experience come equipped to overcome these challenges and successfully bring the products to the market. 

Focusing on formulation development, CDMOs with specialized technology and capabilities also come with extensive experience in selecting the right excipients, valuable insights, and expertise and ensuring maximum stability and bioavailability of the drug. After formulation finalization, manufacturing the product in a state-of-the-art facility is easy as CDMOs are well-versed in handling complex to simple OSD manufacturing, adhering to Good Manufacturing Practices (GMP).  

An important part of all this is following the regulatory guidelines. Any experienced CDMO understands what will and will not align with the requirements set forth by the FDA. This gives emerging pharma companies confidence that their products are being developed and manufactured following industry standards, enhancing trust and fostering long-term partnerships. 

How can one ensure that the right partner matches the expectations, quality, timeline and budget? Optimizing Operations in Multiproduct Pharma Manufacturing Facilities White paper published by Societal™ CDMO lays out the details. 

Societal™ CDMO is a US-based pharmaceutical contract development and manufacturing organization that can take your product from early chemistry, manufacturing, and controls (CMC) development to the first commercial product launch and beyond. Societal™ boasts accessible and transparent teams where you can talk freely to project managers and pharmaceutical scientists working on your product.  

With extensive experience developing small-molecule pharmaceutical finished dosage products from bench-top feasibility studies to commercial manufacturing and packaging, find out how Societal can help develop and deliver your subsequent drug development or commercial manufacturing project. 

We would love to learn more about your next project or some of the challenges you are facing.

¹Oral Solid Dosage Pharmaceutical Formulation Market – 2032 (futuremarketinsights.com)