Formulation Development
Pioneers of Oral Thin Film and Transdermal Patch Delivery
ARx leverages 60 years of formulation and polymer science expertise to support our leadership position in designing drug products that meet our partners desired delivery profiles with safe and effective clinical outcomes. With several ARx formulations patented and approved by the FDA, we select excipients to achieve the desired physical and chemical properties for each drug product, ensuring the intended pharmacodynamic and pharmacokinetic profile in both branded and generic product categories.
The ARx formulation development strategy begins with a strong foundational understanding of the specified dosage form. Our pharmaceutical chemists work closely with partners to determine the objectives and benefits of incorporating specific active pharmaceutical ingredients (APIs) into our transdermal and dissolvable film drug delivery for the patient and drug application. From project inception, we carefully consider the client’s filing and IP strategy to assure a commercially viable product for oral, buccal, sublingual, transdermal or topical drug delivery.
ARx Formulation Benefits:
- Formulation Flexibility: From rapid onset to controlled release for avoidance of adverse events, ARx formulations overcome key barriers in traditional dosage forms.
- Excipient Expertise: Materials selected according to compendial standards, the preferred drug product pharmacokinetic profile, the desired physical and chemical properties, critical quality attributes, and intellectual property strategies.
- In-Vitro Permeation: Enhanced testing capabilities allow us to select the best formulation for clinical success.
- Intellectual Property Strategy: Our intellectual property portfolio can be leveraged by partners for drug product protection. With a solid understanding of the intellectual property landscape, ARx guides partners in product IP strategies.
- Success in Downstream Processing: Formulation and Engineering teams work closely together utilizing the knowledge of production capabilities during formulation selection.
Chemistry, Manufacturing, & Controls Support
Leading product to regulatory approval as experts in our dosage forms
We approach projects with the passion and belief that our dosage forms have the power to enhance patient lives. As a dedicated and comprehensive partner in product development, ARx, LLC., supports the submission of drug products beyond formulation and manufacturing. Our project management team collaborates with each partner throughout the product design control process to properly manage all chemistry, manufacturing, and controls (CMC) regulatory filing elements. Quality by Design is woven into all steps of product development, providing direct access to and relationships with subject matter experts throughout the entire development process. As a single source partner, the ARx team accelerates product development with expertise in the critical attributes of our dosage forms.
Additional CMC Support Services:
- Pre-Clinical Study Design and Material Production: ARx ensures pre-clinical studies for toxicology, sensitization, irritation & pharmacokinetic are designed with expertise in the dosage forms.
- Investigational New Drug Support: ARx provides the appropriate CMC documentation throughout formulation development to ensure fast submission and review of an IND for clinical trials.
- Phase I through III Clinical Production: On-site, clinical manufacturing lab & production suites provide cGMP units for pilot to registration scale clinical studies.
- Product Development and Registration Reports: Authored throughout the development process to ensure a comprehensive package is provided to the regulatory authorities utilizing QbD principles.
- PMP-Certified Project Management: ARx project managers lead partners through the design control process, aligned with the appropriate regulatory filing path and critical milestones.