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Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
A vibrant array of colorful pills and capsules is scattered in a pile, showcasing the expansive world of API life.

Expand/Extend Your API Life with a Topical Formulation

Let’s Topical It!

Many important topical drug products started their life as oral therapies. From antifungals to NSAIDs to retinoids, metronidazole, and minoxidil—topical formulations containing these APIs have become essential treatments for fungal infections, arthritis pain, actinic keratoses, acne, wrinkles, rosacea, and hair loss. Interestingly, all of these active pharmaceutical ingredients (APIs) were first FDA-approved for different indications in oral form.

Take minoxidil, for example. Loniten® (minoxidil) Tablets (2.5 mg and 10 mg) were approved in 1982 for the treatment of high blood pressure. It wasn’t until 1996 that Rogaine®—a topical 2% and 5% solution—was approved for the treatment of male pattern baldness. The product later underwent an over-the-counter (OTC) switch in 1996, becoming widely accessible to consumers, with gender-specific formulations eventually added to the market.

Similarly, metronidazole was first approved as an oral tablet (Flagyl®) in 1963 for the treatment of anaerobic trichomoniasis, amebiasis, and bacterial infections. In 1988, MetroGel® 0.75% was approved as a topical treatment for rosacea, initially designated as an orphan drug. Since then, additional topical formats—such as 1% cream and lotion formulations—have received FDA approval for broader use.

A more recent example is Zoryve® (roflumilast) Cream 0.3%, which was approved in 2022 for the treatment of plaque psoriasis. Originally, roflumilast was approved as an oral product (Daliresp® 500 mcg tablets) in 2011 to reduce the risk of COPD exacerbations. Since then, topical development has continued, including the approval of Zoryve Foam and Cream 0.15% for extended dermatologic indications.

Repurposing existing APIs as topical treatments can offer a compelling path to lifecycle extension. While it’s essential to ensure that a topically applied drug reaches adequate concentrations at the site of action to elicit a clinical response, the benefits of topical delivery can be significant. These include avoidance of first-pass metabolism, targeted local action, and often a more favorable safety profile compared to systemic exposure.

 

References

  • Drugs@FDA: FDA-Approved Drugs – https://www.accessdata.fda.gov/scripts/cder/daf/
  • FDA OTC Switch for Minoxidil (Rogaine) – https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019501ap.pdf
  • Topical Drug Delivery Review – NCBI – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023056/
  • Zoryve FDA Approval History – https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215983Orig1s000TOC.cfm