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Product Development Centers
Locations: Boston MA, USA; Strasbourg, France
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Capsugel's state-of-the-art Product Development Centers were built a on simple premise: help pharmaceutical companies around the world achieve exceptional results.
For lipid-based formulations, Capsugel utilizes its Licaps® Drug Delivery System to overcome bioavailability issues for poorly water soluble NCEs, reformulate existing drugs to extend patent protection, and develop line extensions for OTC products.
Offering services from pre-clinical to commercial production, we are remarkably flexible in terms of partnering with clients to match their exact needs. For example, Capsugel can handle formulation development through scale-up and then help the client take production in-house. Or, we can perform the commercial manufacturing for the client.
For more information on our Product Development Centers click on one of the tabs above, or contact us at one of our worldwide locations.
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- Improved bioavailability, particularly for poorly water soluble compounds…more details
- Formulation of compounds with low melting points and low dose/high potency attributes
- Safer containment for high potency compounds
- Faster time-to-market due to less complex formulation and development processes
- In-house manufacturing possible when using the Licaps Drug Delivery System
- Ease of scale-up and validation
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Improved bioavailability of poorly soluble drugs
Maximum bioavailability is achieved by keeping the drug in the amorphous/solubilized state. This prevents the compound from "crashing out" of solution, into an insoluble crystalline form during in-vivo release in the GI tract.
In Vivo Bioavailability
- Rat Model
In vivo study in rats show improved bioavailability of two Self-Emulsifying Drug Delivery Systems (SEDDS) compared to aqueous suspension of Ontazolast (100mg/kg).
Gelucire 44/14: polyglycolized glyceride
Peceol: glyceryl mono-oleate; a pre-digested lipid
Reference data on file
In Vitro Dissolution
In vitro dissolution profiles of capsule formulations of an experimental drug* show the ability of various solubility-enhancing excipients to substantively impact the dissolution of a poorly soluble active. (USP paddle method at 50 rpm in 37º C water; 0.2% w/v polysorbate in 900 ml water).
In Vivo Bioavailability
- Dog Model
In vivo bioavailability studies in dogs show a significant bioavailability advantage of the liquid capsule dosage form, in support of the in vitro dissolution data shown above.
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Capsugel relies on both conventional and advanced screening capabilities to optimize the performance of drug compounds at our Product Development Centers. One of the advanced tools used is our Lipidex Expert system; a sophisticated computer based model, it draws on both public and proprietary technical information to quickly and efficiently guide the development of liquid formulations.
Analysis of phase diagrams of excipents identifies ways to achieve stable microemulsions
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Capsugel is capable of handling high potency compounds up to OEB-4 (1-10 mcg/m3 OEL). Formulating such compounds in liquids allows for safer containment and reduces potential risks for workers.
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Pre-formulation Activities
- Weighing cabinets with laminar air flux
- Precision balances
- Ultrasonic baths
- Microscope equipped with polarized light filter and hot stage
- Stability cabinets for sample storage in ICH conditions
Compatibilities Activities
- Dessicators
- Purified water station
- Dissolution bath (USP I & II) associated with a spectrophotometer
- Disintegration apparatus
- pH meter and conductimeter
Formulation and Scale-up Activities
- Formulation preparation equipment (heating baths, mixers, beakers etc.)
- Photon Correlation Spectroscopy (PCS) granulometer
- Viscosimeter
- Densimeter
Equipment for Additional Studies
- Karl Fischer apparatus associated with an oven and an auto-sampler
- pH stat titrator
Production Activities
- Facility
- Heating ventilating and air conditioning (HVAC) system class ISO 8
- Weighing & Preparation
- Laminar air flux cabinet
- Precision balances
- Mixing vessel with temperature control
- Licaps Manufacturing
- Soft Gelatin Capsules Manufacturing
- Automated gelatin melter
- Soft gelatin capsule encapsulation machine with tumble dryer
- Capsule hardness measurement equipment (Bareiss Gelomat and Texture Analyzer)
- Powder Precision Filling
- Capsule Inspection Equipment
- Capsule weight sorter
- Lightening inspection table with transparent trays
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The center's pre-clinical services include:
Formulation Development
- Lipid-based pre-formulation
- Lipid-based formulation using Licaps capsules and related liquid fill technologies
Analytical Development
- Analytical method development and optimization
- During pre-formulation, chemical stability screening is re-formed for lipid-based excipients
- Chemical stability follow-up of lipid-based formulations is then performed under accelerated conditions
Small-Scale Manufacturing for Animal and Stability Studies
- For liquids and semi-solids, our innovative CFS 1200 benchtop machine fills and seals Licaps two-piece hard capsules. SGcaps softgel capsules may also be utilized.
- For powder fills, our Xcelodose® S micro-dosing machine fills capsules with drug substances alone, thereby eliminating the need for excipient compatibility and pre-formulation activities
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Small-Scale cGMP Clinical Batch Manufacturing
- For liquids and semi-solids, our innovative CFS 1200 benchtop machine fills and seals Licaps two-piece hard capsules. SGcaps softgel capsules may also be utilized.
- For powder fills, our Xcelodose® S micro-dosing machine fills capsules with drug substances alone, thereby eliminating the need for excipient compatibility and pre-formulation activities
Analytical Activities
- cGMP analytical development and validation
- Development of specifications
- ICH regulatory stability studies
- Cleaning method development and validation
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Large-Scale cGMP Clinical Batch Manufacturing
- For liquids and semi-solids: Licaps capsules or SGcaps softgel capsules are utilized
- For powder fills, two-piece capsules are utilized
Formulation
- Formulation optimization to enhance the manufacturing process or stability through addition of anti-oxidants or chelating agents
Analytics
- Continued analytical development of dissolution methods
- Transfer of analytical methods for clinical batch manufacturing between Capsugel and customer cGMP sites
Process Development
- Scale-up from development scale (CFS 1200) to industrial equipment through rheology studies and equipment (e.g. nozzle and pump) selection
- Technology transfer support from Capsugel to customer through proof of concept manufacturing on LEMS® equipment
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Commercial manufacturing capabilities include production services for liquid and semi-solid fills in either two-piece Licaps capsules or SGcaps softgel capsules. Support services we offer include:
- Process optimization
- Production for scale-up and validation batches
- Analytical development activities:
- Method optimization activities
- Analysis of scale up and validation batches
- ICH regulatory stability studies
- Analytical transfer organization
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Pharmaceutical / OTC
