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.
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.
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About the Author:
Dr.
Ajay Kumar Singh, M.Sc. (Gold Medalist), Ph.D. is the author and founder of
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Disclaimer:
Examples used in this article are not meant to be endorsements of any product or technology from the author.
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