ARx Formulation Development

The ARx formulation strategy begins with a strong foundation and understanding of the specified dosage form. Our pharmaceutical chemists work closely with customers to determine the objectives and benefits of incorporating specific active pharmaceutical ingredients (APIs) into our adhesive and dissolvable film technologies. From project inception, we carefully consider the client’s filing and IP strategy to assure a commercially viable product for oral, buccal, sublingual, transdermal and topical drug delivery.

ARx leverages over 50 years of formulation and polymer science expertise to support our leadership position for predicting the critical quality attributes of the dosage forms we produce. We select excipients to achieve the desired physical and chemical properties for each drug product, ensuring the intended pharmacodynamic or pharmacokinetic profile and convenience for the patient in both branded and generic product categories.

ARx Formulation Benefits
Excipient Expertise Materials are selected according to compendial standards, desired physical and chemical properties, regulatory filing type, critical quality attributes, and intellectual property strategies.
Foundational Knowledge ARx formulates with importance placed on order-of-addition, rheology, drug uniformity, target product profile, and stability.
Intellectual Property Strategy IP strategy discussed with partners at project initiation.
Single and Multi-Layer Systems Experience formulating both single- and multi-layer films and patches based upon application needs.
Definition of Target Product Profile and Critical Quality Attributes As experts in the dosage form, ARx drives elements of QbD design from project inception.
Success in Downstream Processing Formulation and engineering teams work closely together with knowledge of production capabilities during formulation selection.
Stable Products Excipients, substrates and packaging materials are screened and evaluated for selection of a stable and pure product.