Drug delivery and Excipients
GMP excipients & biomaterials – custom services
With its range of polymers for the pharmaceutical industry, PCAS is one of the main suppliers of functional excipients for controlled & slow release of injectable drugs. Our portfolio of biodegradable polymers - well known under the Expansorb® brand, are manufactured according to the GMP standards used for parenteral administration bioresorbable implants and medical devices.
PCAS also offers a special non-toxic solvent - Glycofurol -, well known to dissolve non-hydrosoluble medicinal products, and Benzethonium Chloride, used as an antimicrobial or antiseptic in certain injectable or ophthalmic preparations
Expansorb® (PLA/PLGA polymers): biocompatible and biodegradable polymer
Expansorb® (PLA/PLGA polymers): biocompatible and biodegradable polymerPoly (D, L- lactide), Poly (D,L-lactide, co-glycolide acid), block polymers, etc. are used as a controlled and sustained delivery system of drug substances with continuous effect from one week to several months. These polymers are usually used to do away with multiple injections, high toxicity and to achieve the desired therapeutic effect.
PLA & PLGA copolymers advantages
- Bioabsorbable and biocompatible polymers
- Safety proven in human and currently approved by the FDA as an excipient in drug delivery systems of injectable APIs
- Polymers used in the formulation of marketed drugs
- Known materials for medical devices
Expansorb kit-box or catalog offeringPCAS offers a PLA/PLGA screening kit allowing researchers to find the suitable polymer for each formulation in the early stages of development as well as bulk quatities.
You can choose your 8 samples from our catalog (10g each)
GMP excipients & biomaterials – custom services
Drug delivery and medical devices
Resorbable polymers, full service for development under CDA, scale-up, clinical batches and production under GMP, etc.
GMP ingredient used in diabetes monitoring
Glycofurol N+1/N+2 to N+1/N+5 Water-soluble and nontoxic solvent to solubilize insoluble drugs (parenteral application clearly described in the European Pharmacopoeia)Solid supports production
- Custom production of purification media for therapeutic proteins
- Resins used to functionalize peptides after synthesis: Amberjet 4600 Ion-Exchange Resin
- Solid Support ChemMatrix® Resin: A new solid phase produced by PCAS used to produce with higher purity synthetic peptides (long, complex or hydrophobic peptides)
The main known applications are:
- Parenteral controlled delivery or depot medicines (slow-release) - such as small substances, peptides, therapeutic proteins, hormones, antibiotics, etc. - formulated using PLGA-grade injectable polymers.
- Medical devices containing PLGA: this is the second area of use: sutures, surgical plates, tissue engineering and regenerative medicine.
- New developments: the applications of PLA/PLGA are now being extended to medical imaging, regenerative medicine, vaccines, etc.
know-how & technologies
Polymers know-how and expertise in GMP Materials
- PCAS has been a PLGA/PLA supplier for more than 18 years
- The knowledge to fine-tune your own polymer: PLA, PLGA, block copolymers and derivatives
- Technologies: ring-opening polymerization or ROP, PEG polymerization, dry and wet sieving, proven track record on ethylene oxide production
- Analytical resources and manufacturing units operate according to ICHQ7 and cGMP guidelines
- Drug Master File available, possible IMPD filling and DMF for new PLA or PLGA
- Project leader and reporting
- Confidentiality and strict compliance with customer’s IP
Product transfert & industrialisation
- Full development capabilities: a complete development service under CDA, scale-up, clinical batches, GMP-compliant production, etc
- Broad industrial capacity (4 FDA inspected sites from kilo-lab to multi-ton scale)
- Regulatory Affairs and Quality Assurance teams
Drug delivery and slow release
Small molecules, peptides, hormones, antibiotics, etc…formulated using PLGA -grade injectable polymers extended release covering weeks to several months.
A number of well-known medicines on the market have been using PLGA sustained release since 1988 (not exhaustive list): Sandostatin LAR ( octreotide ) , Decapeptyl® ( triptorelin ) , Zoladex ( goserelin ) , Lupron Depot (leuprolide acetate) , Somatuline ( anréotide ) ... etc.
Source, public Web site: eurekasante, Doctissimo , e-sante
Orthopedic soft tissues repair by Inion HEXALON
Biodegradable screw: Secure fixation and maintain the stability of bone-tendon-bone grafts. PLA with Trimethylene carbonate are mainly used to prepare this kind of screw. Gradually the screw loses strength during 18-36 weeks and totally resorbed in 2 to 4 years.
Resins used to purify proteins like insulin and other proteins
Proteins are produced in microorganisms or animal cells and then purified from 1000 of hosts’ protein to have a pure desired product to be considered for human us (therapeutic proteins). Specific resins are used since decades to clarify media or purify proteins.