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Fixed Dose Combinations
Fixed-dose combinations are increasingly being used to simplify dosage regimens (e.g., reduce the number and timing of dosage units the patient must take) and improve patient compliance, particularly among patient populations with special needs such as geriatric and pediatric patients. In addition, these fixed-dose combinations are being used to achieve highly specific drug-delivery profiles, achieve targeted release to specific sites within the body, and to extend product life cycles.
Formulation Science Expertise
Our multidisciplinary teams work with clients to clearly identify the market opportunities, formulation challenges and key physical and chemical properties of the compound and dosage form requirements. Using our collective expertise in formulation science, we have an extensive history of tailoring drug release profiles with Capsugel technologies.
Combination Drug and Dual-Release Technology
Some fixed-dose combinations employ dual-release profiles for pulsatile- or combination-release functionality to target more than one area of the gastrointestinal (GI) tract.
Capsugel offers several approaches to achieve combination-drug or dual-release functionality in a single dosage unit. The choice of approach is based on the active ingredients, target product profiles and commercial objectives for the combination drug product. We are well versed with the challenges related to fixed-dose combinations (e.g., the formulation includes one or more low-solubility active ingredients, dose ranging and assessing and addressing drug-drug interactions.
Dosage forms may include:
- Multiparticulate or mini-tablet coating using a combination of matrix and drug layering approaches
- Bi- or tri-layer matrix tablets
- Liquid-filled capsule-in-capsule technology
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Proven Capsule-In-Capsule Capabilities
Capsugel liquid-filled capsule-in-capsule technology — an advancement of our premier liquid-fill hard-capsule technology — provides proven capabilities for novel pharmaceutical and nutraceutical line extensions. Using custom-designed filling equipment and specialized liquid-filling techniques, capsule-in-capsule technology allows a prefilled, smaller capsule to be inserted into a larger, liquid-filled capsule. The smaller inner capsule may contain either a liquid, solid or semisolid formulation and — based on the formulation or product requirements — either or both capsules may be made of gelatin or hydroxypropyl methylcellulose (HPMC). They may also be coated, if desired, for additional functionality (e.g. delayed release, pulsatile release) or targeting of sites such as the colon.
Capsule-in-capsule options include:
- An inner capsule that contains a liquid, semi-solid, powder, or pellets
- An outer capsule that contains a liquid or semi-solid formulation
Wide-Ranging Applications
Capsule-in-capsule formulations are manufactured using custom liquid-fill equipment and sealed with either banding or proprietary “Fusion” or LEMS® Sealing Technology. The technology is incorporated into our integrated product- development model — with equipment scaled for pilot through clinical trials — and commercial-scale production.