A Patient-Centered Approach to Liquid Filled Hard Capsules
Patient centered therapies focus on the patient as a whole, addressing distinguishing factors such as cultural background, lifestyle, personal values and socioeconomic circumstances to develop a comprehensive and effective treatment plan that meets the needs of the individual. This adds a layer of complexity to the development and manufacturing process, as drug makers are faced with the challenge of delivering both in terms of therapeutic value and consumer convenience.
Oral solid dose (OSD) has long been the preferred dosage form among patients worldwide and the one most commonly used to treat a wide variety of therapeutic indications. According to Future Market Insights, OSD formulations held 37 percent of the North American market share in 2017, with that number expected to increase at a compound annual growth rate (CAGR) of 6.5 percent through 2027(I). However, as the formulations pharmaceutical innovators are seeking to commercialize become increasingly complex, so too is the process of optimizing them for oral dosage forms. Stringent measures must be in place to preserve the integrity of the product both throughout the manufacturing process and for the duration of its proposed shelf life.
Though packaging of the final drug product may be the last literal step in the manufacturing process, facilitating the effective delivery of the active pharmaceutical ingredient (API) is a consideration that must be made from the earliest stages of development. In this way, product packaging is a key consideration that should span the entire value chain not only to ensure the product remains intact until the active ingredient is meant to be released in the body, but that patients are able to access the medicine in the dosage form—and packaging—with which they are most comfortable.
Setting the Stage in Early Development with Liquid Filled Hard Capsules
To develop commercially successful patient-centered therapies, manufacturers must be focused on the needs of the patient as a whole, from bioavailability of the active ingredient to the preferred route of delivery. Due to their inherent flexibility over tablets, two-piece hard capsules are an appealing option for manufacturers looking to encase complex liquid formulations—including those that are highly potent, poorly soluble or sensitive to light and heat degradation—in the dosage form most widely preferred by patients. Liquid-filled hard capsules (LFHCs) help to overcome many of these challenges, significantly reducing the risk of degradation, leakage, cracking or a number of other factors that could potentially compromise the integrity of the active ingredient.
While LFHCs are widely known for their efficacy, quality and versatility in encapsulating liquid formulations, the challenge does not end there. Before the product nears the packaging line, it is imperative to consider how the active ingredient will be contained within the dosage form itself. With an LFHC, for instance, the fill material must be compatible with the capsule shell polymer to achieve stability of the API and excipients in the end product. Deficiencies in the development and manufacturing process can lead to costly and potentially hazardous issues on the market.
The two most common packaging forms for OSD, blisters and bottles, provide their own respective benefits for pharmaceutical manufacturers and patients, though there are advantages and drawbacks to each depending on the materials being stored. Bottles are generally a more cost-effective, convenient way for patients to maintain a larger on-hand supply of their medicines, but depending on the nature of the formulation, blister packs are often preferred. If a capsule happens to leak in a bottle, it has the potential to render the entire batch ineffective or unsafe whereas blisters provide a single-use solution with the added benefit of moisture control for extended shelf life.
During manufacturing, it is critical to ensure the product will be able to withstand the varying ambient conditions it will inevitably face post-production, particularly while being transported to its final destination. A highly sensitive liquid formulation, for instance, should be secured with a sufficient banding solution and packaged in a blister pack to maintain its integrity amid extreme temperature fluctuations during transport.
Proper packaging is a central component of designing a patient-centered medicine, both in medicinal value and consumer convenience. Innovative capsules and complementary technologies are empowering manufacturers with the means to overcome some of the most historically difficult delivery challenges associated with complex APIs to provide safe, effective therapies that meet the requirements and preferences of patients worldwide.
(I) Oral Solid Dosage Pharmaceutical Formulation Market – Global Industry Analysis, Size and Forecast, 2017 to 2027: https://www.futuremarketinsights.com/reports/oral-solid-dosage-pharmaceutical-formulation-market (last checked on Jun. 14th 2018)
Director of Business Development, The Capsule Group