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See Dow Development Laboratories’ FormulationForum for articles and resources on various topical drug product development topics of interest.

Management of IP for Your Clinical Study – K.I.S.S.

Management of IP for Your Clinical Study – K.I.S.S.

Keep It Simple, Smart. Planning for investigational product (IP) supply in a clinical study is often more complex than it seems—but the guiding principle should always be to Keep It Simple, Smart (yes, we’re softening the original “stupid” just a bit!). Complexity can...

Expand/Extend Your API Life with a Topical Formulation

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,...

Improving the Robustness of Semi-Solid Formulations

Improving the Robustness of Semi-Solid Formulations

Eliminating Operator Dependence from Gelling Agent Addition - Improving the Robustness and Processing Time of Semi-Solid Dosage Forms Without Impacting the Viscosity or Aesthetics Ruth Yu, Jason Carbol Dow Development Laboratories, LLC PURPOSE Aqueous gelling agents...

The Importance of Being Labeled Correctly

The Importance of Being Labeled Correctly

Among the myriad steps involved in pharmaceutical product development, clinical labeling and packaging stand out as critical components that need special attention. Clinical trials are typically the most expensive part of the already costly and years long...

The Use of Forced Degradation in Analytical Method Development

The Use of Forced Degradation in Analytical Method Development

There are two times when forced degradation studies are needed when developing a stability-indicating method for the analysis of a drug product[1].  The first set of studies uses only the active pharmaceutical ingredient (API).  Since the goal of the method is to...

Analytical Method Development for Semisolid Drug Products

Analytical Method Development for Semisolid Drug Products

The creation of an analytical method for the measurement of the API and degradation products in a semisolid formulation happens in parallel with the creation of the product itself.  If the API is a repurposed drug substance, there is typically an existing method that...

Poster Presentation at AAPS PharmSci360

Poster Presentation at AAPS PharmSci360

Critical Material Attributes (CMA) of Excipients in Topical Formulations: The Pitfalls of Switching Between Compendial Raw Materials Without a Full Analysis of all Critical Quality Attributes (CQA)   PURPOSE With the FDA introduction of Quality by Design (QbD) many...

How many pea-sized amounts are you going to use?

How many pea-sized amounts are you going to use?

The FDA Inactive Ingredient Database (IID) is heavily used by formulators when developing drug products.  This resource has been available since 19871 and has since informed the inactive ingredient (excipient) selections and concentrations made by formulation...

CMC Roadmap for Topical Drug Products

CMC Roadmap for Topical Drug Products

CMC is critical to a successful topical drug product program.  Important aspects of CMC that are unique to topical products are discussed in this presentation.

Scale-Up of Topical Products: Math Matters

Scale-Up of Topical Products: Math Matters

Proper scale up of a 1 kg batch to a 1,000+ kg batch takes engineering effort to execute properly.  Why is this so difficult?  The short answer is because of the math.  The physical forces on a semi-solid product while manufacturing a 1 kg laboratory batch vs. that of...

To Suspend or Not to Suspend

To Suspend or Not to Suspend

Pros and Cons of topical products containing a suspended API Prescription drug products contain an active pharmaceutical ingredient (API)1. While traditional topical drug product development focuses on dissolving the API, challenges can arise from dissolved systems....

Making pimple popping a thing of the past

Making pimple popping a thing of the past

Acneic skin can involve inflammation, comedones, excess sebum production and bacteria. Effective topical products for the treatment of acne must be designed with patient compliance in mind. Topical Formulations Made for Patients – Acne Products When developing topical...