www.chemicalsknowledgehub.com
Topical Products
The Romaco Unipac 20100 Tube Filler is also used in semi-solid manufacturing, specifically to fill PVC, laminated and metal tubes with topical products in quantities ranging from 2-250g.
● Microbial testing for objectionable species (there are some species that must be zero)
● Microbial enumeration of microorganisms in a product and comparison of that to release specifications (typically 100 CFU/mL)
Additional preservative efficacy testing and antimicrobial effectiveness testing (AET) are performed prior to launch/ approval of a product to assess the effectiveness of antimicrobials preservatives added to the formulation. In any case of failure, speciation testing must be performed.
Topical formulation manufacturing
The number of pharmaceutical companies with the right level of existing topicals manufacturing capacity and internal topical dosage expertise is very small compared to the number of oral
Summer 2020
solid dosage-focused firms. Most often, it is not cost-effective for these companies to manufacture every product themselves. Particularly in the case of complex topical formulation development, scale-up and commercialization, it is common for this work to be outsourced to an expert contract development and manufacturing organization (CDMO). Regardless of whether
formulation and manufacturing are done in house or outsourced to a CDMO partner, achieving
a stable, clinically effective and cosmetically acceptable formulation is critical to success. Due to the highly specialized science of formulating and manufacturing topical products, when outsourcing many companies will look to work with a CDMO that can support the process from start to finish. With formulation development and manufacturing capabilities at its Mirabel, Quebec, Canada site, and sterile ointment production capability at its Whippany,
About the author
Dr Ralph Landau is Head of Development at Cambrex’s Whippany, NJ site and has 30 years of pharmaceutical experience in both branded and generic businesses. With formal training in chemical engineering, he has spent the majority of his career leading operations and R&D/regulatory functions in a number of companies, including Merck & Co, Novartis, Fougera and Sandoz, and over the past decade has led several companies through compliance and profit growth initiatives.
New Jersey, US site, Cambrex offers a one-stop approach to topical formulation from process development, through to scale-up, transfer and commercialization. Across the company’s drug product sites, high-performance semi-solid formulation support is available from 10kg to 900kg with complementary packaging options. Cambrex is able to work with new products or complete technology transfer for existing products to bring safe and effective topicals to the market by combining state-of-the-art technologies, accessible capacity, and a quality-driven approach, thus safeguarding the integrity of the process for the life of the product.
Further information: Dr Ralph Landau Head of Development Cambrex Whippany, NJ, USA Email:
ralph.landau@
cambrex.com
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