CREATING FORMULATIONS FOR POORLY WATER SOLUBLE MOLECULES
Ascendia’s expertise involves finding the most effective method of drug delivery for poorly water soluble molecules. Our comprehensive range of capabilities enables clients to optimize their drug product formulation prior to initiating expensive clinical development. We provide practical, customized formulation solutions that enable rapid advancement of compounds from discovery to clinical testing. We provide trial formulations suitable for initial animal studies and toxicology studies using our nano-emulsion, amorphous solid dispersion, controlled release and nano-particle engineering approaches. We conduct pre-formulation testing, formulation approach comparisons, dosage form design and formulation optimization. By working with Ascendia, our clients can quickly determine the feasibility of multiple technical approaches in parallel, thus improving the probability of formulation success and reducing the time required to make critical early-stage formulation decisions.

LIFE-CYCLE MANAGEMENT AND 505(b)(2) PRODUCT DEVELOPMENT
Ascendia is dedicated to the solubility and bioavailability enhancement of difficult-to-formulate compounds. Our proprietary product development programs focus on creating novel specialty pharmaceutical products that are improved versions of existing medicines. We develop oral, topical and injectable products. We enter into licensing arrangements to co-develop both 505(b)(2) and ANDA products

MANUFACTURE OF cGMP CLINICAL TRIAL MATERIALS
Following formulation selection and optimization, Ascendia can transition a development program quickly to cGMP manufacture of first-in-man clinical materials. Ascendia’s manufacturing capabilities include dosage forms for oral, topical or parenteral administration. Ascendia offers its manufacturing services to third parties that need a CDMO partner for their formulation as it transfers from a pre-clinical phase to early clinical development.

Ascendia Pharmaceuticals services

Others

Parenteral Formulation Development Services