Ascendia is a specialty pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia provides state-of-the-art formulation development solutions for poorly water soluble molecules, and cGMP manufacture of clinical trial materials. Applying its nano-particle technologies and pharmaceutical development expertise, Ascendia can rapidly assess the feasibility of a broad array of formulation options in order to improve a drug’s solubility and bioavailability. Our technologies include nano-emulsions, amorphous solid dispersions, oral controlled release, self-emulsifying drug delivery systems (SEDDs) and production of nano-particle
Ascendia offers a wide array of pharmaceutical development capabilities for manufacturing and analyzing drug product dosage forms. We specialize in providing contract manufacturing services to emerging and specialty pharma companies that need expertise to outsource manufacture and release of small scale clinical batches.
Whether the program is for a novel injectable product, a tablet or capsule for oral administration, or topical delivery of a poorly water soluble drug, Ascendia can be your manufacturing partner. We are rapid, comprehensive and flexible with our clients - work with Ascendia to access efficient advancement of your drug development project to first-in-man clinical testing.
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.
Our experienced formulation development team can overcome these issues. Our services will provide you with a formulation that you can be confident will be suitable for clinical scale-up. Ascendia provides these expert contract formulation development services rapidly and cost-effectively - let us help bring your molecule to market.
We develop and evaluate oral formulations for preclinical and early human studies. In addition to traditional granulation approaches, we offer a wide range of advanced technologies for your drug delivery challenges.
Our nano-emulsion formulations are prepared by high shear homogenization and then incorporated into either solid or liquid dosage forms.
Our amorphous solid dispersions can be processed by hot-melt extrusion, solvent evaporation, or spray drying, and then granulated and tableted.
Our nano-particle formulations are prepared by bead-milling, microfluidization, or homogenization, and then incorporated into a solid dosage form.
Our controlled-release formulations can provide enteric protection, colon targeting, sustained release with pH-independence, pulsed release or combinations thereof. Dosage forms can be either a capsule or tablet.
We develop and evaluate parenteral formulations for preclinical and early human studies. There are a couple of key considerations for the development of a parenteral pharmaceutical product: the administration route (intravenous, intramuscular, or subcutaneous) and the requirement for a sterile, pyrogen-free dosage form.
During development, the formulation is optimized via pH adjustments, co-solvents, complexation, surfactants and combinations of these methods. Different dosage-form concepts can be developed: solutions, suspensions, emulsions, or a lyophilized powder for reconstitution (if stability is an issue).
We design and evaluate topical formulations for administration to the skin or eye. There are a number of factors that must be considered during the development of a topical pharmaceutical product: viscosity, taste, ease-of-administration, skin sensitivity, and color to name a few. In particular, for ocular delivery, a formulation must not irritate the eye, and transparent drops are a key benefit.
PRE-FORMULATION DATA PACKAGE
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. During the pre-formulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The knowledge gained on the API helps to select the right salt or polymorphic form, and supports the design and development of an initial dosage form, both for pre-clinical and clinical use. Ascendia's pharmaceutical science team characterizes the drug candidate by evaluating its solubility profile, physical and chemical stability, and potential salt forms; and identifies impurities and degradation pathways. Characterization of the API during pre-formulation may include determination of: dissociation constant (pKa), partition coefficient (Log P), BCS classification assessment, particle size and morphology (laser diffraction, microscopic imaging), crystallinity (X-ray diffraction), thermal properties (melting point and glass transition), solubility studies in organic and pharmaceutical solvents (at various pH and in simulated media), excipient compatibility studies, and forced degradation studies (heat, acid, alkali, light, peroxides, metal ions).
Ascendia can generate the data needed for your CMC package in support of an IND filing, and the data guides the development of small-scale formulations for in vivo pharmacokinetic, efficacy, and toxicology studies or proof-of-concept testing.
SMALL-SCALE FORMULATIONS FOR PRE-CLINICAL TESTING
Ascendia develops and evaluates a variety of formulations for preclinical non-GLP and GLP studies. We understand the needs of companies with an exciting compound in the discovery pipeline, but with limited amounts of drug substance. We have developed methods for carrying out formulation screening studies with as little as several mg of drug substance. These methodologies can be used to formulate new drugs for initial in vivo experiments when only low milligram quantities of the drug have been synthesized and/or purified.
After screening, our formulation development includes feasibility studies to determine compatibility of excipients, active ingredients and delivery components, formulation selection, and optimization. We provide statistical experimental design, short-term and accelerated stability studies, and analytical method development and validation. Using our expertise in modeling and simulation (e.g., GastroPlus and WinNolin), we can predict the animal PK profile and propose an efficient formulation strategy for preclinical studies accordingly. Often these small-scale formulations are provided in liquid form, developed for various routes of administration (oral, iv, ip, sc, etc.).
Depending on the drug candidate’s solubility properties, lipids, surfactants, complexation agents, and co-solvents can be added to increase solubility, and hence enhance solubility and bioavailability for initial animal testing.
Particle size and selection of a suspending vehicle are frequently critical factors impacting the stability and dissolution rate. Micronization of the drug substance by jet milling, or wet milling in a suspending vehicle, can therefore be important to obtain good bioavailability of a poorly water soluble drug substance.
Preparation of nano-suspensions of a poorly water soluble drug substance further increases the dissolution rate (by increasing the surface area). A nano-suspension of a poorly water soluble drug substances may show a faster dissolution rate and a higher solubility/bioavailability when compared to a micronized suspension.
If dictated by solubility data (in oily vehicles, co-surfactants and solvents), an emulsion – a fine dispersion of oil droplets – can be formulated to improve the initial probability of success. The drug may be dissolved or suspended in either the oily liquid, formulated as an emulsion, and/or then further incorporated into solid matrix or aqueous liquid phase.
Ascendia maintains chambers for conducting both non-GMP and cGMP stability studies in accordance with ICH guidelines. Our stability studies are used to:
Ascendia conducts stability studies on the oral, topical and parenteral dosage forms we manufacture as clinical trial materials for our clients. The chambers/conditions we test for stability at include:
We also conduct photo stability as necessary using an ATLAS Sunset CPS chamber (conforming to ICH Q1B guidelines)
Product Development & Testing Services
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