Research and Development - Controlled release
Mardi 4 octobre 2016
Generate value for our customers; In sustainable partnership mindset, Vifor Pharma develop, formulate and produce medicines to make a difference for the life of the patient.
Customized Development approach:
Vifor Phama has established a strong experience in the development and the production of microtablets. This technology presents many technical advantages providing our partners with personalized solutions with products having atypical characteristics.
By this application the patient benefit a comfortable intake of the médicine
Regular batch size: 50 to 500 kg
Development batch size: until 10kg
Formulation of mixture adapted for the compression.
Industrial rotative 30 stations compression
Tableting speed: up to 4 mio microtablets/h
Max. compression force for microtablets: 30kN
Multi-tips punches: 30 tips/punch
Pilot compression: FETTE 102i rotative press
29 stations encapsulation machine, speed: 20’000 to 75’000 capsules/h.
Multi-dose system, encapsulation speed: 10’000 to 35’000 capsules/h.
Dosage of several type of microtablets in the same capsule: 100% weigh-check.
These forms deliver a controlled dissolution profile: high flexibility of drug load, immediate or modified release by functional coating or matrix effect with clinical advantages (gastro-intestinal tolerance).
This technology allows to combine several types of microtablets containing different API and different dissolution profiles. Solving also incompatibility issues.
The analytical procedure of weighty control is applied for the validation of capsules filled with microtablets.
Fig.1: dissolution profile determined by HPLC technology according to the Pharmacopeia method.