GENERAL INFORMATION:
Company description/summary :
Aptys pharma, specializing in the design of formulations, develops innovative products for its account through its branch Aptys pharmaceuticals and its clients through Aptys pharmaservices. Loramyc® and Testocream® are based on Aptys pharma technologies. Metapain®, a combination of two analgesics is currently in phase III. Aptys pharmaservices includes one design laboratory equipped to carry out preformulation and innovative formulation design, and a GMP-compliant laboratory specializing in analytical development, quality control, and ICH stability studies.
Aptys helps its clients to go to GMP production.
Indeed, Aptys can deliver a ready-to-use package consisting in: formula + recipe + validated analytical methods + stability data on prototypes.
SUMMARY PRODUCTS / SERVICES / TECHNOLOGIES
Description
Aptys pharma offers different kinds of services :
preformulation of poorly soluble and poorly bioavailable molecules
custom-made formulation design and development
in vivo/in vitro assessments
development of peptide-based products
analytical development & validations
quality control and ICH stability studies
Aptys Pharma skills and know-how :
Soludiag®: a step-by-step approach using a small amount of active substance to assess the solubility of active substances
Nanosolution®: a one-shot nano milling technology using a small amount of active substance and 30 different conditions to improve the bioavailability of poorly soluble active substances
Nanosuspension/micro-suspension/liposomes
Injectable depot of peptides
Immediate-release and sustained-release tablets
…
COMPANY ASSETS
PREFORMULATION:
1. Solubility studies :
SoluDiag®is a straightforward method to assess the solubility of active substances. The big advantage of SoluDiag is a step-by-step approach using a little amount of active substance
2. Bioavailability improvement
NanoSolution® is a technology that allows the optimization of nanomilling of poorly soluble active substances to improve their bioavailability. The advantage of Nanosolution: one can evaluate 30 different conditions in one shot using a little amount of materials
3. Others
Forced degradation, excipient screening, Log P, dissolution testing (USP1, 2, 4)
FORMULATION DESIGN & DEVELOPMENT
Formulation design is historically the heart of our business at Aptys pharma®.
Our formulation design laboratory is equipped to design every type of formulation, such as tablet press, fluid bed, granulator, freeze drier, homogenizers, and mixers plus testing equipment (sieves, polarised light microscope, halogen moisture analyzer, viscosity meter, hardness tester, friability tester, tap density tester, disintegration meter, pH tester, particle size analyzer).
Aptys pharma® is, above all, capable of rapidly designing and preparing formulations for pre-regulatory pharmacological trials, a usual starting point for our biotech customers.
The company has already developed immediate and controlled-release tablets and granules, injectable microspheres, microcapsules, gels, creams, solutions, and suspensions.
DEVELOPMENT OF PEPTIDE-BASED PRODUCTS
Aptys pharma® possesses this experience, namely through its CEO, François Boutignon who filled the post of vice-president responsible for R & D at Europeptides, a biotech company established in 1991, then at the French subsidiary of Mediolanum Farmaceutici, before moving on to Asta Medica. During this time, François developed several innovative peptide-based products, including injectable depot formulations of GnRH analogs (biodegradable implants, microspheres, and microcrystals).
Aptys pharma® has, since its inception, been regularly tasked to design peptide-based medicines and to provide its clients with not just strategic advice, but also to develop and validate suitable quality control methods for evaluating these formulations. The company has notably developed injectable biodegradable implants of GnRH agonists and injectable biodegradable microspheres of GnRH antagonists.
ANALYTICAL DEVELOPMENT & VALIDATION
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 and UHPLC), Thin layer chromatography (TLC), UV & IR spectrophotometry and dissolution apparatus (USP1, 2 ,4).
Our personnel develops assay 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.
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.
QUALITY CONTROL & STABILITY STUDIES
Aptys pharma®’s analytical laboratory is both GMP-compliant and WHO accredited. It is comprehensively fitted out with the necessary equipment for the quality control of raw ingredients, medicines and stability studies that include High-Performance Liquid Chromatography (UHPLC, HPLC), Thin Layer Chromatography (TLC), UV and IR Spectroscopy, and USP 1, 2, 4 dissolution testing apparatus, ICH stability-controlled chambers (25°C/60% RH, 30°C/65%RH, 40°C/75% RH, 5°C, -20°C). The laboratory’s equipment is accredited, and its IT systems have been validated to 21 CFR part 1 standards.
Aptys pharma® carries out quality control and stability studies on tablets, capsules, microspheres, solutions, suspensions, creams, generic molecules, new chemical entities, peptides, and hormones.
ADDITIONAL INFORMATION
Founded (year)
2002
Source of foundation
University of Auvergne
State of ownership
Private
Employees (worldwide)
10-49
Corporate Highlights
2002: acquisition of rights on formulation patents from the University of Clermont-Ferrand.
2003: license of a transdermal technology to Ardana Bioscience (UK).
2004: development of an inhaled generic product for big pharma (marketed).
2005: license of a buccal bioadhesive technology to Bioalliance (Loramyc®, marketed).
2007: development of an enema for a European pharmaceutical company (marketed).
2009: first round fundraising.
2014: sale of Testocream and Bigel® technology to Viramal ltd (phase III).
2016: development of Metapain®
2018: second round fundraising.
2019: third round fundraising.
2022: phase III Metapain®
