What are The Key Considerations of Excipient Custom Manufacturing?

 

Custom Manufacturing

The FDA defines an excipient as a stable ingredient deliberately added to therapeutic and diagnostic products, which are not intended to exert therapeutic effects at the intended dosage, but which may act to increase product delivery (e.g., improve absorption or key release of the drug substance). 

Excipients are highly diverse and serve a critical role in optimizing drug delivery. According to recent researches, the pharma excipients Custom Manufacturing market will reach approximately $9.78 Billion by 2025, growing at a CAGR of approximately 6% from 2018 to 2025. 

Example of excipients 

Release Modifiers:  Often polymers (e.g., PLGA, TPU, and Silicone) that enable long-acting drug delivery systems such as implants and depot injections.

Suspending Agents:  Material that increases viscosity to form sterile or non-sterile semi-solids and oral suspensions.

Here are the key considerations for excipient selection 

Quality of excipient 

When it comes to excipient quality, it should be remarked that there is no ‘different’ excipient manufacturing industry. Unlike APIs, which are usually provided by pharmaceutical manufactures following the applicable Good Manufacturing Practices (GMP), excipients are typically produced and packaged by chemical organizations. Several materials are utilized as excipients with applications outside of pharmaceuticals, such as food additives, cosmetics, or industrial commodities. 

Thus, environmental conditions, material, and operational procedures used in excipient Custom Manufacturing are often those of the chemical industry rather than those of the pharmaceutical industry. It should be recognized that poor quality excipient can result in failure during manufacturing, ineffective drug products, and compromised patient safety. 

Custom Manufacturing

Safety

An inactive ingredient is each component of a drug product other than the active part and should be safe at its intended use levels. Presently, there is no separate administrative pathway for security evaluation or approval of excipients. Excipients are reviewed only as a part of a drug product application. 

API-Excipient Compatibility

Excipients introduce various advantages to drug products, but the developer's obligation also is aware of unintended interactions between APIs and excipients. These interactions can affect both the chemical and physical properties of the drug. Several analytical tools may be required to evaluate compatibility, including

Separation and quantitation methods: Provide chemical identity and stability information for both the APIs and excipients. Examples include high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS), size-exclusion chromatography (SEC), and gel electrophoresis. 

Physical characterization methods: Provide information on interactions that may change the solid-state form of a drug or alter the physical properties of the drug product. Models include laser diffraction (for particle size analysis), X-ray powder diffraction (XRPD), and differential scanning calorimetric (DSC).


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