Capsule in capsule technology

Capsule-in-capsule supplements are manufactured using specialty liquid-filled hard-capsule technology (LFHC). The capsule-in-capsule form allows for better release profiles that more precisely meet a customer’s target release. With liquid-filled hard-capsule technology, you have the option of immediate, extended, pulsed, or delayed release, unlike that of other forms. This allows for delivery of supplement or OTC compounds to two different regions of the GI tract, and even delivery to the colon with the addition of enteric coatings. This single oral dosage delivery system, which involves inserting a smaller pre-filled capsule containing either a liquid or semi-liquid formulation   into a larger liquid-filled capsule, offers numerous possibilities and a broad range of formulation and design options. New compounds in the pharmaceutical pipeline are increasingly complex and typically requires enabling technologies to address challenges such as solubility, permeability, stability, metabolism, regional absorption, or food/pH sensitivity. Therefore, pharmaceutical and nutritional companies today require a diverse range of technologies and dosage forms to develop customized solutions that improve delivery of their products to the body.

Liquid-filled hard-capsule technology (LFHC) is one delivery method that is popular due to its simplicity in manufacturing design and technology transfer process, and its versatility in providing sophisticated solutions for a vast range of pharmaceutical formulation and delivery needs. This technology is increasingly utilized to address key formulation challenges in advancing new chemical entities or improving existing products, including enhancing bioavailability, highly potent and low dose applications, combination products, intestinal targeting, and colonic delivery.

Large varieties of excipients are available for use in Liquid-filled hard-capsule technology (LFHC) based on the purpose of the formulation. Compatibility with the capsule shell and viscosity at the temperature of filling up to 70oC are most important considerations.

Capsule-in-capsule technology: liquid/liquid, liquid/semisolid, liquid/beads

This technology facilitates:

  • Formulating combination products or dual release of a single ingredient
  • Providing multiple release profiles
  • Unique finished product presentation for brand recognition

The above-mentioned capsule-in-capsule approach provides a simple solution to achieve the variable release profiles. Capsules can be used for immediate release or combined release for example solubilized prebiotics in the outer capsule and probiotics in the inner capsule.  The prebiotic gets released immediately and the probiotic later on. The inner capsule of this unique delivery system can contain liquid, semi-solids, powder or pellets, while the outer capsule can be either a liquid or semi-solid formulation. Liquid-filled hard-capsule technology (LFHC) is well-established for formulation and manufacture.

Safe manufacturing for high potency drugs:

More than 25% of pharmaceutical drugs today contain highly potent active pharmaceutical ingredients (HPAPIs).  Projections indicate that the global market for highly potent active pharmaceutical ingredients (HPAPI) drugs will grow. Liquid-filled hard-capsule technology (LFHC)is ideal for high potency drug manufacture. Once the highly potent active pharmaceutical ingredients (HPAPI) are added to the mixer to form a liquid, its potential for airborne and accidental exposure is greatly reduced in contrast with other oral solid forms, which require much more stringent control, especially during the preparation of the final dosage forms directly from powders such as tableting and powder filling.

An effective for low dose formulations:

Uniformity of dose poses the most significant challenge for the formulation of low dose products throughout development, validation and commercial manufacture. A benefit of liquid-filled hard-capsule technology (LFHC) is that once a liquid solution is prepared, dose uniformity is assured through excellent weight control attainable during filling. This provides a simple solution for assuring uniformity for low dose applications which, aligned with highly potent compounds, are increasingly prevalent in pharmaceutical development pipelines.

Conclusion:

Liquid-filled hard-capsule technology (LFHC) is a relatively straightforward and can be utilized to meet a number of formulation and manufacturing challenges. It offers tremendous advantages in process development and technology transfer, thereby accelerating the pharmaceutical development cycle.

Liquid-filled hard-capsule technology (LFHC) provides versatile solutions to a number of significant challenges facing the pharmaceutical industry. This includes the large number of drug candidates that are poorly soluble, the suboptimal tailoring of drug release profiles to maximize efficacy and minimize side effects, the low dosage required of some medications, and the stringent manufacturing containment policies required for highly potent active pharmaceutical ingredients (HPAPIs).

It is the combination of such simplicity and versatility that makes Liquid-filled hard-capsule technology (LFHC) particularly relevant to modern product life cycle management, where there are increased regulatory demands on product and process understanding on the one hand, and ever aggressive generic competition on the other. 

Query:

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About the Author:

Dr. Ajay Kumar Singh, M.Sc. (Gold Medalist), Ph.D. is the author and founder of “Pharma Solutions by Dr. Ajay”.

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Examples used in this article are not meant to be endorsements of any product or technology from the author.


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