ARx develops oral thin films and transdermal patches with pharmaceutical teams for patients underserved by traditional tablets and injectables, from pediatric and geriatric to rare disease, oncology, CNS, and more. Regardless of your intended indication, our scientists work alongside your team to match the format to the molecule and the patient it needs to reach.
As a family-owned drug delivery partner and CDMO, ARx has spent two decades building these technologies and the manufacturing to scale them. That means one team can carry your program from feasibility through manufacturing, giving you a faster path to clinic and commercialization.
Tell us where your program stands, and we’ll map what it takes to get to market →
HOW WE START
After you submit, our business development team schedules an introductory call with our technical team to discuss your API, target dosage form, and development stage. That conversation leads to a feasibility assessment based on your molecule’s physicochemical profile, target indication, and regulatory timeline.
Before any bench work begins, we evaluate your API’s solubility, permeability, stability, and compatibility with film-forming excipients. We select excipients based on that profile, grounded in established formulation science.
Computational models built on decades of OTF, sublingual, buccal, and transdermal data predict whether your molecule can be delivered. For transdermal programs, in-silico enhancer screening identifies the combinations that maximize flux.
Epi-Oral tissue models characterize mucosal absorption for buccal and sublingual formats. Franz diffusion cells and cadaver skin studies measure transdermal flux with high-fidelity human permeation data.
We then characterize candidate formulations with in vitro release, disintegration, burst strength, and mucoadhesion testing, plus taste-masking studies where palatability matters. What we learn shapes formulation design, GMP prototyping, clinical manufacturing, and registration.
WHY ARx
ARx serves as a drug delivery technology partner or CDMO, depending on your program’s needs.
We bring 20 years of commercial experience, multiple FDA-approved 505(b)(2) and ANDA programs, and billions of doses produced. Our team carries programs through registration, launch, and post-launch performance tracking.
Our scientists have spent careers learning what thin films and patches can and can’t do, and you work with them directly. Dedicated program management and transparent communication keep us aligned to your timelines and critical decision points.
ARx is part of the Huber family of companies, a fourth-generation, family-owned organization founded in 1961. We operate our own quality system and production suites, and our parent company, Adhesives Research, brings 60+ years of pressure-sensitive adhesive chemistry.
R&D, analytical, CMC, clinical and commercial manufacturing, and packaging all sit at our FDA-registered Glen Rock, PA site. We maintain full GMP compliance with 21 CFR Parts 210 and 211 and a strong record of FDA and DEA inspections.
CASE STUDY
A specialty pharma company’s buccal buprenorphine candidate was mid-program when its development partner shut down, leaving the company in need of a new path to clinical supply.
ARx stepped in to carry the program forward. We solved the suspension challenge across several product strengths and manufactured Phase 1 through 3 clinical lots on schedule. With clinical supply secured, the program reached FDA approval as the first buccal film for its indication.
FAQ
It depends on your API’s physicochemical profile, dose, target onset, and patient population. Here’s where each format fits:
Pre-formulation screening confirms the best fit for your specific molecule.
That’s what our feasibility assessment is for. Pre-formulation screening and in-silico modeling evaluate your molecule before you commit lab resources, so you get an answer before investing in development. For a primer, read what makes a molecule right for oral thin film formulation.
Our formats fit programs where administration, absorption, or GI exposure shapes what a molecule can do, which is common in rare disease, pediatric, geriatric, CNS, and oncology programs. For pediatric programs, films that dissolve without water simplify administration and support PREA requirements.
Yes. We produce GMP placebo films in different flavors and sweeteners for a consumer panel you define, then use an electronic tongue to measure how well each formulation masks bitterness against the selected placebo.
Any stage. We work on programs from concept and pre-formulation through clinical development, registration, and commercial supply.
Your API and any physicochemical data you have, such as solubility, permeability, or stability, along with your target dosage form, indication, and timeline. Partial information is fine, and our team can help fill the gaps.
Start with as much or as little as you’re comfortable sharing. The API field is optional, and our team can put a confidentiality agreement in place before technical discussions go deeper.
Yes. We provide CMC support and regulatory documentation, and produce registration batches for ANDA and NDA submissions, backed by multiple FDA-approved 505(b)(2) and ANDA programs.
From several thousand units for early clinical studies to millions of units for commercial supply. We run clinical and commercial batches at our Glen Rock, PA site, so your program scales without a site transfer.
Yes. Our FDA-registered site is DEA-registered for Schedule II-IV (CII–CIV) substances and has a strong record of successful FDA and DEA inspections since 2006.
Yes. Our quality system covers the 21 CFR Part 820 requirements that apply to drug-device combination products.
Each stage of development with ARx, from pre-formulation through commercial manufacturing, creates opportunities to expand your product’s intellectual property estate.
Yes. We take on technology transfers for thin film and transdermal programs, including ones that stalled with another partner, like the buccal film program above. Select Technology Transfer in the form to get started.
Bring us your molecule, and we’ll find the right format for it. With ARx, you’ll work directly with our scientists, backed by a fourth-generation, family-owned company that can carry your program from feasibility through commercial supply.
Bring us your molecule, and we’ll help it deliver everything it’s capable of.
Prefer to reach us directly? Call +1 (877) 727-6275 or email ma*******@*******ma.com.
