GP Pharm - Drug Delivery Formulations for Urology, Oncology, CNS and CVS

GP Pharm, the pharmaceutical company of the Lipotec Group, specialises in developing drug delivery formulations for the urology, oncology, central nervous system (CNS) and cardiovascular (CVS) fields. GP Pharm is a specialist in R&D for drug delivery formulations, and can also manufacture and commercialise drug products.

GP Pharm is able to produce cytotoxics and hormonal drug products in drug delivery formulations for itself and also for third parties.

Manufacturing of sterile formulations for injection

GP Pharm carries out manufacturing of sterile formulations for injection. These include:

• Cytotoxic products
• High-potency products
• Drug delivery systems: microspheres and liposomes

Various types of packaging are available, including vials, ampoules and pre-filled syringes. Both liquid and freeze-dried formulations are available. GP Pharm fulfils the annex 13 requirements of the GMPs so that in addition to pilot batches, validation batches and industrial batches, the company is also authorised to produce clinical batches.

Microspheres for drug delivery

GP Pharm has experience in obtaining microspheres through different technologies such as double emulsion and coacervation. GP Pharm’s own developments include:

• Agonists LHRH (leuprolide, triptorelin)
• New active peptides
• Peptides somatropin release-inhibiting factor SRIF or GHIH (octreotide LAR, MAR, SAR and somatostatin)
• Other molecules (risperidone)

Liposomes for injection

GP Pharm’s liposomes for injection are suitable for encapsulating cytotoxic compounds to reduce toxicity or increase bioavailability. GP Pharm has expertise using different compositions of lipid components for liposome preparation: cationic, anionic and neutral (used separately or in different ratios). GP Pharm can also obtain liposomes throughout different sizing technologies such as microfluidification, extrusion and sonication.

GP Pharm is developing Sarcodoxome® (liposomal doxorubicin), and is also currently manufacturing Myocet for US company Cephalon.

Peptide-based hormonal products

GP Pharm is currently developing generic hormonal products based on peptides such as octreotide. Octreotide for injection is a pure generic formulation based on a proprietary buffer system. It is registered in different countries worldwide.

GP Pharm is also working on the pharmaceutical development of vasopressin analogs, considering injection and oral solutions as routes of administration.

Desmopressin syrup is a new oral liquid formulation for Desmopressin that is bioequivalent to other oral formulations but offers easier administration (particularly useful for children and the elderly).

Generic cytotoxics for injection

GP Pharm has started development of generic formulations of some well-known cytotoxics for injection, including production of pilot batches, stability data and CTD registration dossiers. GP Pharm is offering these formulations to countries where no patent protection exists. The formulations are:

• Oxaliplatin
• Irinotecan
• Docetaxel
• Gemcitabine

Pharmaceutical licensing opportunities

GP Pharm is interested in expanding its commercial network worldwide and is actively looking for win-to-win partnerships with other companies in terms of in-out licensing. GP Pharm currently has available for licensing:

• Lutrate® (leuprolide one and three month microspheres)
• Irinotecan
• Octreotide (SAR, LAR, MAR)
• Desmopressin oral drops
• Gemcitabine
• Oxaliplatin
• Risperidone
• Sarcodoxome® (liposomal doxorubicin)
• Docetaxel