APTYS PHARMA

WHO IS APTYS PHARMA®?
Founded in 2002, Aptys Pharma® is a company specialized in formulation design,  pre-formulation, and analytical development.

Aptys Pharma® also offers quality control and ICH stability studies thanks to its GMP-compliant and pre-qualified WHO laboratory.

Therefore, Aptys Pharma® clients can start GMP production thanks to a ready-to-use package covering the formula and recipe, the validated analytical methods and ICH stability data.

APTYS OFFER :
Aptys Pharma® proposes different consulting and operation services to its clients, to cover most strategic phases of drug development.

Aptys preformulation expertise is completed by 2 offers: Soludiag® & Nanosolution® which have both the advantage to require low amounts of active substance and being fast.

• Soludiag®a quick process to test the solubility of an active molecule using more than 20 different solvents and co-solvents. The amount of active molecule needed to perform this test is about 100 mg.
• Nanosolution®a quick process to assess the conditions of nanonisation of powder with more than 40 different parameters. The amount of active molecule needed to perform this test is about 1 g.

Aptys formulation design expertise covers a wide range of dosage forms  and particularly peptide-based forms (microspheres), buccal, ocular, transdermal, and injectable forms.

Since 2002, Aptys have developed numerous complex dosage forms. Such as Loramyc®, a sustained release bioadhesive buccal tablet containing miconazole to treat oral candidiasis, and Testocream®, a transdermal cream containing testosterone to treat hypogonadism.

Aptys pharma® has been involved with several partners for more than 15 years in the fight against pain by developing Metapain®, an alternative to opioids.

 

APTYS CLIENTS:
Aptys have mainly 2 types of clients:

• Biotech companies who are seeking for the best formulation to run pre-clinical and clinical tests.
• Pharma companies who need help to develop their products to build the pharmaceutical dossier according to QbD.

APTYS STRUCTURE:
Aptys has 2 laboratories:

• a formulation design laboratory hosting equipment such as tableting machines, fluid bed granulators, granulators, freeze-dryer, homogenizers, and mixers, as well as control equipment: milling and sieving apparatus, polarized microscope, particle size analyser, halogen moisture analyser, viscosimeter, tablet hardness tester, friability tester, tap density tester, disintegration tester, pH meter.
• a GMP-compliant, WHO-qualified analytical laboratory equipped with HPLCs, UV and IR spectrophotometers, GC, titrimeter, coulometer, densimeter, TLC apparatus, dissolution testing (AT7 and USP4), viscosimeter, titrator, ICH stability chambers, balances, and microbalance.

Also, the labs are equipped with isolators and safety cabinets to handle potent and toxic molecules (peptides, hormones).

APTYS STRENGTHS :
Aptys Pharma® helps Its clients to go the GMP product.  Our clients come to us because we can solve formulation problems and make from a bright idea an Industrial reality.

Moreover, Aptys Pharma® has strong expertise in the peptide-based product development to assist their clients from the design of the peptide structure to the final dosage form.