The impact of hot melt granulation method on propranolol hydrochloride physicochemical properties

Ilma Nugrahani, Hasan Rahmat, Joshita Djajadisastra


Hot melt granulation is based on agglomeration by use of thermoplastic binder material that is solid at room temperature and softens and melts at higher temperature. By selecting a binder that is insoluble in water, melt granulation is a way of producing modified release granules, i.e. lipids/waxes to exhange the release of soluble drugs. The critical problem of this method is drugs instability because of heating. It has been studied the impact of hot melt granulation method on propranolol hydrochloride physicochemical properties. Physicochemical properties were evaluated including : water content titration – Karl Fischer, chemical structure analysis by Fourier Transforms Infrared Spectrophotometry (FTIR), and thermodynamic analysis by Differential Scanning Calorimetry (DSC). The results showed that hot melt granulation did not change the propranolol hydrochloride physicochemical structure but it changed anhydrate ß lactose to anhydrate a lactose. Key words : carnauba wax ; hot melt granulation; propranolol hydrochloride; physicochemical properties.

Full Text:



Kibbe, A.H., PhD. 2000. Handbook of Pharmaceutical Excipients, 3ed. The Pharmaceutical Press. London : 252-5, 587-8.

Krummen, G. 1993. Stability Testing in the EC, Japan, and the USA. Wissenschftliche IIerlagsgesellschaft mbH. Stuttgart : 48 –55.

Parikh, D.M. 1997. Handbook of Pharmaceutical Granulation Technology. Marcel Dekker Inc. New York: 48,156, 194 – 198.

Rowe, R.C. 1999. Molecules and Microscopy, Crystals and Chromatography Pharmaceutics in Action. Pharmaceuticals Journal 283 (7063) : 429 – 437.

Swarbrick, J., Boylan, J.C. 1995. Encyclopedia of Pharmaceutical Technology. Marcel Dekker Inc. New York : 305 –324.

Tiwari, S.P., Murthy, T.K., Pai, M.R., Mehta, P.R., and Chowdary, P.B. 2003. Controlled Release Formulation of Tramadol Hydrochloride Using Hydrophilic and Hydrophobic Matrix System. PharmSciTech4 (3).

Watson, D.G. Pharmaceutical Analysis. Churchill Livingstone. New York : 97 – 117.



  • There are currently no refbacks.


Creative Commons License
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Indonesian J Pharm indexed by:

analytics View My Stats