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Hot Melt Technology

2nd Communication: Effect of Manufacturing Method on Tablet Characteristics¹⁾

Heba Guirgis a, Bianca Broegmann b, and Adel Sakr a

Industrial Pharmacy Graduate Program, College of Pharmacy, University of Cincinnati a, Cincinnati, Ohio (USA), and Mundipharma GmbH b, Limburg (Germany)

A full factorial design has been implemented to study the characteristics of granules and tablets prepared by the hot melt technology using the high shear mixer/granulator (HSMB) and the fluid bed processor (FBP). The results were compared with those obtained by direct compression. Granules consisting of theophylline monohydrate and lactose granulated with polyvinylpyrrolidone solution were used as substrate. Hot melt excipients: cetostearyl alcohol (CSA, Lanette® O) and glyceryl behenate (GB) were evaluated using the three manufacturing techniques.
The tablets were compressed using a Korsch PH 106/DMS instrumented tablet machine. The resulting granules and tablets were examined using scanning electron microscopy (SEM) and were evaluated for their physical characteristics. In vitro dissolution tests were done using automated USP apparatus II, at a paddle speed of 50 rpm in 900 ml pH 6.0 phosphate buffer for 20 h. SEM micrographs showed that on applying the melt excipient to the granules in the HSMG, a process of granulation and deposition of the melt excipient takes place while in the FBP granule coating occurs. Experiments were carried out to investigate in depth the mechanism of granule formation and release patterns using hot melt technology.
It was found that using the same amount of melt excipient, direct compression was as successful as the high shear technique in modifying drug release in case of GB, and almost as the fluid bed technique in case of CSA.

Key words Cetostearyl alcohol · Glyceryl behenate · Granulation, direct compression, fluid bed processing, high shear mixer · Hot melt technology