Modified Release Formulations: Extending Drug Commercial Lifecycle 

In the previous blog (Tapping into the Unexplored Through 505(b)(2) Pathway), we discussed one of the benefits of 505(b)(2) pathway that allows drug sponsors to make a substantial modification to the already approved drug, such as changing release formulation to acquire continued market exclusivity from three to five years addressing the challenges of patent expiration and generic competition. 

Growing demand for customized drug delivery solutions, intense competition in the development pipeline, evolving dosage forms, and the complexities of developing and launching novel drugs have instigated a critical factor in meeting the needs of the patient population through pioneering solutions. Creating ideal dosage forms of a drug that are both pharmacologically effective and retain patients on the regimen is the need of the hour, and pharma companies are not only making this a priority but also a key differentiator when compared to other products. By leveraging the advantages of modified release dosage forms, pharma companies can maximize the value of their drug and ensure its long-term success in the market. 

Ways to develop modified release (MR) formulations: 

• Extended Release: These formulations release the drug slowly over an extended period, maintaining therapeutic levels in the body, thereby reducing the frequency of dosing. This includes controlled release, sustained release, and long-acting drugs.  
• Targeted Release:  These are designed to release drugs at a specific site or near to the site of action. 
• Delayed Release: Delayed release is achieved via enteric coating applied to oral medications such as tablets, capsules, and multi-particulates. It is a dosage form that releases a portion of the drug at a time. Non-steroidal anti-inflammatory drugs are the most common examples of delayed-release products. 
• Orally Disintegrating Tablets (ODTs): ODT technologies provide an alternative for geriatric and pediatric populations with difficulty swallowing conventional OSDs. Designed to be easy to administer and transport over liquid medication, fast dissolution, and absorption, and manufacturing can be done using conventional processing and packaging. 

While oral solid dose (OSD) forms account for over 55% acceptance and remain the preferred choice due to convenience and cost-effectiveness, converting them into modified-release formulations and manufacturing can be challenging. Some pharma companies have in-house expertise in modified-release techniques, while several drug development and manufacturing organizations in-license the technology and/or provide manufacturing expertise. MR formulation development requires highly specialized and skilled resources. 

This is where Societal™ CDMO comes in with more than three decades of experience. Societal’s understanding of modified-release dosage forms extends beyond the formulation and processing considerations. We also understand the analytical challenges and regulatory requirements unique to modified-release dosage forms.