In 2013, Aptys pharma®, within the Analgesia Partnership framework, launched the development of Metapain®, a new patent-protected combination of two well-known analgesics, as an alternative to weak opioids for treating moderate to severe pain.
En 2017, we signed a partnership agreement with Unither Pharmaceuticals to co-develop Metapain®.
The pharmaceutical development of the combination was launched in 2017. Following encouraging scientific opinion from EMA in 2019, the partners launched an international multi-centre Phase 3 study in 2020.
In addition to the classic preformulation offers including forced degradation or compatibility studies, Aptys pharma® is in a position to propose two innovative technologies, SoluDiag® and NanoSolution® to its clients, to improve the bioavailability of low solubility molecules. These two technologies were designed on the confirmed observation that 40% of new molecules have solubility and/or bioavailability issues.
Both technologies are based on the same client requirement, especially for biotech companies, to allow the quick testing of several different conditions with a minimum amount of raw material.
Two innovative technologies
A quick way to test the solubility of active ingredients in up to 20 different solvent and co-solvent conditions. The quantities of raw material required for these first tests can be in the order of a hundred milligrams. The technology is based on transmittance.
A quick way to test the nanonisation of powders in up to 40 different formulations. The quantities of raw material required for these first tests can be in the order of just a few grams. The technology is based on ball milling with a dual-rotation centrifuge.
Aptys pharma®’s laboratory is GMP compliant and WHO accredited and fully equipped with all the material necessary to conduct analytical validation, such as High-performance liquid chromatography (HPLC), Thin layer chromatography (TLC), UV & IR spectrophotometry and dissolution apparatus (AT7, USP4).
Our personnel develop methods (HPLC, spectroscopy, burette) and in-vitro dissolution methods for clients and in support of our formulation design laboratory. Once developed, the methods can then be validated and transferred.
These methods are validated according to Société Française des Sciences et Techniques Pharmaceutiques (SFSTP) recommendations. Data is subject to ICH Q2(R1) processing procedures. Our IT systems have been validated to 21 CFR part 11 standards.
Aptys pharma® has developed and validated numerous methods of assay, purity and in-vitro dissolution of tablets, capsules, microspheres, solutions, suspensions, creams, generic molecules, new chemical entities, peptides, and hormones.
Aptys pharma® carries out quality control and stability studies on tablets, capsules, microspheres, solutions, suspensions, creams, generic molecules, new chemical entities, peptides, and hormones.