Tablets & Capsules

TC0917

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HMC and ODGs: A perfect match When developing our vitamin C formulation, the abil- ity to carefully control the rate of API release and improve adherence to the dosage regimen were key con- siderations. Of all the available options, ODGs coated by HMC offered the best solution to these requirements and ensured sustained release while minimizing the potential for non-compliance thanks to ease of swallowing and good taste and mouthfeel. Figure 3 shows the extended-release profile of the coated vitamin C formulation compared to that of the uncoated raw material. While the raw material com- pletely dissolved within 15 minutes, the coated product released just 40 percent after 1 hour. Furthermore, release was approximately 75 percent after 5 hours, demonstrat- ing the formulation's ability to release vitamin C over a sustained period. Vitamin C is a sour compound, so developing a pleas- ant oral experience was also an important consideration. HMC is particularly effective at masking the unfavorable taste of APIs. The technique also enhanced the product's mouthfeel compared to tablets because the formulation doesn't absorb saliva. Scale-up is another important consideration for any formulation. Ideally, the transition from development to commercial manufacture is fast, simple, and cost-effec- tive. HMC is a robust and relatively easy technology to scale up, and that is another reason why this technique was adopted. T&C References 1. Jannin V, Cuppok Y. Hot-melt coating with lipid excipients, Int J Pharm, 2013, 457, 480-487. 2. Hermes Pharma, A Hard Truth to Swallow? www.swallowingtablets.com. Accessed 26 July 2017. Martin Koeberle, PhD, is head of analytical development and sta- bility testing, and Detlev Haack, PhD, is head of R&D at Hermes Pharma, a division of Hermes Arzneimittel, Georg-Kalb-Strasse 5-8, 82049 Pullach, Germany. Tel. +49 89 791 02 261. Website: www.hermes-pharma.com. Tablets & Capsules September 2017 37

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