AMS focuses on advanced products, active substances and challenging APIs with a potency up to OEL ≤ 1µg/m3 as well as low solubility or low dose drugs. Product portfolio includes oral forms, oro-dispersible dosage forms, inhalation products and other drug delivery systems (e.g., vaginal rings, suppositories). Advanced formulation concepts, applied by AMS for solubility & wettability enhancement, include:
- Molecular solutions and dispersions:
Solid solutions (API is in molecular form) and dispersions (API is in particle form) are used in various routes of drug administration including oral, mucosal (vaginal, rectal, buccal, occular), subcutaneous, subdermal, and transdermal forms. Two significant challenges in drug delivery can be addressed using such forms, including bioavailability enhancement and controlled drug release. Solid solutions and dispersions are typically made by a melt approach (e.g., in a hot-melt extruder) or by solution methods. Carrier materials are usually polymers, sugars or fats and waxes.
- Solid nano-suspensions:
Solid nano-suspensions are a special form or solid dispersions where drug APIs in the form of nano-crystals are directly embedded in a polymer. Solubility enhancement and controlled drug release can be simultaneously achieved.
Pharmaceutical co-crystals are single-phase molecular crystals of an API formed through non-ionic interactions with excipient molecules in a stoichiometric ratio. Co-crystallization is a promising strategy for enhancing aqueous solubility, and thus, oral bioavailability of APIs with low aqueous solubility. Various manufacturing platforms exist, including extrusion and high-shear milling. The solvent-free nature, continuous manufacturing capability, several precisely-controllable process parameters and adaptability of particle engineering of HME makes it a promisingly green and scalable process for efficient manufacturing of co-crystals
- In situ salts:
Many pharmaceutical salts experience poor physical and chemical stability, and salt formation is in general a challenging process. AMS uses a HME platform for manufacturing in situ salt solid dispersions of poorly water-soluble active pharmaceutical ingredients
- Amorphous forms:
When no crystalline form, including salts, co-crystals or pharmaceutically-acceptable solvates are available or if the crystallined forms are poorly an morphous drug may be isolated by a variety of methods including precipitation, desolvation of a solvate or melting and solidification in a hot-melt extruder. AMS has these capability with the potential to improve bioavailability via use of an amorphous form.
Manufacturing technologies include:
- Hot-Melt Extrusion
- Die-face pelletization
- Die casting
- Spray drying