FOR TEAMS EVALUATING AN ORAL THIN FILMS OR TRANSDERMAL CDMO
As pioneers in film and adhesive polymer science and novel dosing strategies, ARx helped shape modern drug delivery through higher standards for quality, safety and efficacy. From formulation through commercial-scale manufacturing, see the delivery formats, regulatory record, and technology behind every program ARx takes on.
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MicroDEP Low-Dose OTF Patent Expires
FOR COMPOUNDS THAT NEED FLEXIBLE ABSORPTION ROUTES
Dissolves on the tongue in 5 to 30 seconds and releases API into saliva for GI absorption, supporting drug loading up to 65mg across salts, free-base compounds, and potent APIs. That flexibility makes it a practical fit for patients with dysphagia, including pediatric and geriatric populations.
Dissolves under the tongue and enters systemic circulation directly through the sublingual mucosa, bypassing hepatic first-pass metabolism entirely. In human studies, quantifiable API appeared in plasma within 5 minutes, with Tmax reached by 30 minutes.
Adheres to the inner cheek and releases API through the buccal mucosa over a controlled window of 30 minutes to 12 hours, also bypassing first-pass metabolism. In testing, buccal films achieved 2x the systemic exposure at just 25% of conventional drug loading, with no toxic metabolites detected.
FOR COMPOUNDS THAT NEED SYSTEMIC OR LOCALIZED DELIVERY
Routes API through the skin directly into systemic circulation, bypassing GI transit and first-pass hepatic metabolism. Controlled release extends up to 7 days per application, supported by enhancer combinations engineered to optimize permeation and steady plasma levels.
Delivers API directly to the treatment site, limiting systemic absorption and confining pharmacokinetic exposure to the local tissue itself. Release rate and duration are calibrated to indication, tissue type, and API permeability, tailored to each specific program.
FOR POTENT, LOW-DOSE COMPOUNDS
MicroDEP is ARx’s patent-protected, FDA-approved technology for APIs that need dosing below a standard matrix film’s limits, depositing precise, individual droplets directly onto the film’s surface for accuracy down to 10 μg. Available in buccal and sublingual formats, it’s built for rapid onset directly into systemic circulation through the oral mucosa.
Patent-protected through 2039
Dosing accuracy down to 10 μg
4x+ API concentration at 30 minutes vs. conventional film
3x+ API concentration at 2 hours vs. conventional film
Statistically significant results vs. placebo
Scales from clinical to full commercial batch volume
FOR COMPOUNDS THAT NEED SYSTEMIC OR LOCALIZED DELIVERY
Precision coating equipment monitors film thickness in real time, while oven drying under controlled conditions protects API integrity as the film cures. The same lines that wind, slit, and package finished film also scale from Phase I batches of a few thousand units to commercial orders exceeding 100 million units annually.
FDA-registered, cGMP-compliant facilities operate under 21 CFR Parts 210 and 211 for drug products and CFR 820.20, .30, .50, and .100 for combination products, with DEA registration covering CII–CIV. That foundation backs multiple approved 505(b)(2) and ANDA programs, alongside a clean inspection record since 2006.
Development starts with feasibility screenings on solubility, permeability, and film-forming compatibility, backed by proprietary in-silico modeling that predicts pharmacokinetic outcomes. That same process also supports lifecycle management, turning injectables into an oral film or multi-day dosage into a single patch.
CASE STUDY
When a specialty pharma company’s development partner shut down mid-program, their buccal buprenorphine candidate had no path to clinical supply. ARx inherited an unsolved suspension challenge across seven product strengths, manufactured Phase 1, 2, and 3 clinical lots on schedule, and carried the program to first-in-class FDA approval.
That approval left the sponsor with more than a cleared filing: it led to a validated, repeatable commercial process that was ready for launch, plus a regulatory timeline that never slipped despite the mid-program disruption.
DELIVERY PLATFORM
Buccal Film
API CHALLENGE
Partial Water Solubility, 7 Strength Variants
TRANSFER TRIGGER
Development Partner Shutdown, No Commercial Capability
REGULATORY FILING
NDA, Phase 1, 2, & 3 Clinical Supply
OUTCOME
First FDA-Approved Buccal Film for This Indication
START WITH ARx
ARx is your drug delivery partner and CDMO, full-service and family-owned, with format-specific manufacturing and a regulatory record built on more than two decades of approvals. From standard thin film and transdermal formats to a technology built for potent, low-dose APIs, the first step for any program is the same: a feasibility assessment to see what your compound needs.
