The Keys to Quality Modified-Release Formulation Development Services

Post Date: June 27, 2024
Written By: Tedor Pharma Services

Modifying the release of a drug product’s active pharmaceutical ingredient (API) is one of the most significant areas of innovation in small-molecule oral solid dosage (OSD) forms. However, formulating drug products to modify or sustain the point of release can be a sizable challenge to drug developers, motivating many to turn to experienced contract development and manufacturing organizations (CDMOs) for formulation development services.

Increasing Demand for Modified-Release Drug Formulations

Modified-release (MR) drug products are OSD forms — typically tablets, pellets, or capsules — designed to release their API in a specific way that differs from traditional, immediate-release (IR) drug products. The history of oral MR delivery solutions can be traced back to 1938, when coated pallets first prolonged the release of a drug’s API for the desired therapeutic effect. MR formulations have come a long way since 1938, and there are now several types of MR types used in formulation development, including:

  • Extended release (ER) — formulations that release the API over a longer period of time and at a consistent concentration.
  • Sustained release (SR) — formulations that release the API at a predetermined rate, lengthening the drug delivery time.
  • Controlled release (CR) — formulations that deliver the API at a predetermined rate and a constant concentration.
  • Delayed release (DR) — formulations that release the API at a predetermined time.

The market for MR drug products is projected to rapidly increase over the next several years, as they often have improved efficacy and much wider therapeutic applications than traditional OSD products. Some experts forecast that the global market size of CR delivery alone will reach $106.3 billion by 2030, with a compound annual growth rate (CAGR) of 10.4%.

What Makes MR Drug Formulation Challenging?

Effective formulation is a critical step in safely and efficiently advancing MR drugs to clinical trials and to market. However, the formulation of MR drug products is much more complex than traditional OSD drugs. For example, manufacturers need to understand the physicochemical (PC) characteristics at a deeper level, and modifying the release of an API is typically achieved by coating the API in materials that can delay, control, or sustain release, requiring specialized processing and process development technologies and experience.

Also, regulatory filings for MR drug products are more complex than traditional OSD products. Specifically, developers must collect sufficient data to show the desired release modifications are consistent across all doses. MR drug products may also negatively interact with food and other drugs in a patient’s body, so potential chemical interactions must be studied early in development.

Coating: The Key to Effective MR Formulation Development Services

MR drug products are often coated in polymers to protect APIs from stomach acids. Therefore, MR manufacturers must have coating expertise in addition to the standard formulation techniques of APIs and excipients.

Coating requires specific processing technology, and once manufacturers have selected their preferred material and coating technology (typically pan or fluid bed coating systems), they must coat the drugs in a controlled environment. There are several considerations and essential unit operations involved in coating a drug product, such as:

  • Enteric Coating — applying a polymer barrier to prevent dissolution or disintegration in the gastrointestinal (GI) tract.
  • Spray Rate & Volume — the rate and volume at which a drug product is coated in material.
  • Inlet Air Temperature — using temperature to dry the drug product after coating.

Coating methodologies will vary from drug to drug, and the required post-coating procedures can change drastically depending on the desired release modification. After coating, manufacturers will need to conduct numerous assays in order to prove uniform coating and consistent release.

Partnering for Success and the Role of a CDMO

Effectively navigating drug formulation can save innovators time and money in later phases of development. Because of the state-of-the-art technologies needed to formulate and manufacture MR drug products, drug developers often turn to CDMOs for pharmaceutical formulation development services.

Outsourcing partners with experience in MR formulation development services can quickly identify critical quality attributes (CQAs) and critical process parameters (CPPs) of their partner’s drug product to develop quality formulation methods. One-stop CDMOs, like Tedor Pharma, are especially desirable because they can support developers from formulation through manufacture, allowing developers to avoid costly tech transfer.

Tedor Pharmaceutical Services: A Reliable Outsourcing Partner

Tedor Pharma Services is a US-based CDMO specializing in oral solid dosage drug products and has extensive experience formulating and manufacturing MR and ER drug products. Founded in 2001, Tedor combines scientific expertise in OSD drug formulation and close collaboration with partners to create comprehensive pharmaceutical outsourcing solutions.

Our team leverages years of experience and cutting-edge technology to quickly understand the characteristics of your drug product, allowing us to tackle modifying the release of your drug product early and efficiently. ​​As your one-stop CDMO partner, Tedor will evaluate formulation design options, design, validate, and implement analytical and process methodologies, and assist in regulatory filings by generating robust data.

But don’t just take our word for it; get in touch with us today and let us show you our commitment to customer success.