With five trademarked DDS, and several French and worldwide patents for its original and exclusive systems for galenic formulations, Galenix says it stands among European pharmaceutical R+D leaders
In 2006, Galenix opened its technology platform in its GMP facilities to include contract services for formulation, analytical development, clinical batches production, quality control, and regulatory submission.
The company will be exhibiting at Bio 2007 from May 6 to 9 in Boston at the French Pavilion, booth 1528.
Situated near the community of Saint-Jean d'Illac near Bordeaux, France, Galenix has developed three proprietary DDS for oral or parenteral use in slow, fast, or bimodal modified-release profiles: Microgix, Minextab, and Minextab Floating.
Microgix is a dispersed system that improves the bio-availability and/or solubility of chemical entities or biologicals.
The active pharmaceutical ingredient is first dispersed in a water/oil or oil/water preparation.
The preparation is then adsorbed in a powder that can be packed in sachets, stick packs, or used for manufacturing tablets, capsules, or parenteral dosage forms.
Minextab is intended to reduce the tablet size thanks to a reduced excipient level (less than 15% of the formula).
This DDS is designed for high-dosage forms (500 to 1000 mg) or lower-dosage forms for pediatric use.
Minextab Floating is intended for drugs with gastric absorption.
It also reduces tablet size, but makes the tablet float above the food in the stomach.
In this system, two excipients react with water and form CO2 bubbles that are captured inside the matrix to lift the tablet above the surface of food.
Galenix had also developed two trademarked powders, Mucolys Film and Mucolys Flash, for incorporation in spray-delivered medicines or in stick packs.
Mucolys Film forms a film once in contact with the mucous membrane inside the mouth.
The film will remain for a maximum of five hours and release the drug through the mucous membrane.
This allows a sustained release and avoids the first-pass effect.
Mucolys Flash is a powder in a spray.
The powder dissolves in less than five seconds in the saliva under the tongue.
This technology serves the purposes of immediate-release drugs that need to avoid the first-pass effect.
In addition to developing DDS for biotech and pharmaceutical companies, Galenix is involved in the whole pharmaceutical development process.
Between the company's three divisions, Galenix innovations, development, and pharma, it provides sub-contracted pharmaceutical development services including characterization of the active pharmaceutical ingredient, formulation, analytical development, clinical batches production, stability studies, quality control, and regulatory submission (NDA, CTD).
The company currently employs 74 people including highly qualified engineers, PhDs, post-doctorates, and technicians, and meets FDA and European GMP requirements.
In 2006, Galenix's turnover was euro12.2 million (US$16.5 million).