Hakim El Mabrouki1, Irina Evgenievna Kaukhova1. 1. Saint-Petersburg State Chemical Pharmaceutical University, Department of Industrial Technology of Drugs, Saint-Petersburg, Russia
Abstract
Objectives: The present study aims to develop a moisture-protective coating solution and use it to film coat hygroscopic Herniaria glabra L. tablets. Materials and Methods: Five coating formulations were developed and applied on H. glabra core tablets in a fluidized-bed coating. The film-coated tablets were evaluated by appearance, percentage of moisture gain, disintegration time, and percent of drug release. Physicochemical properties and stability during storage of the best obtained coated tablets were studied. Results: The results of this study showed that the film coating F5 containing 25% hydroxypropyl methyl cellulose (HPMC), 20% shellac, 10% polyethylene glycol (PEG) 1500, 29.6% PEG 4000, 5% tween 80, 10% titanium dioxide, and 0.4% acid red 2 offered good protection for coated tablets against moisture. Coated tablets showed physical and dissolution stability during storage. Conclusion: A combination of hydrophilic polymer HPMC and hydrophobic polymer shellac is suitable for balancing moisture-protective properties and attaining the fast release of drugs. This study could make it worthwhile to develop a pharmaceutical moisture barrier film coating system for immediate release tablets. However, more studies will be needed to evaluate the moisture-resistant film further.
Objectives: The present study aims to develop a moisture-protective coating solution and use it to film coat hygroscopic Herniaria glabra L. tablets. Materials and Methods: Five coating formulations were developed and applied on H. glabra core tablets in a fluidized-bed coating. The film-coated tablets were evaluated by appearance, percentage of moisture gain, disintegration time, and percent of drug release. Physicochemical properties and stability during storage of the best obtained coated tablets were studied. Results: The results of this study showed that the film coating F5 containing 25% hydroxypropyl methyl cellulose (HPMC), 20% shellac, 10% polyethylene glycol (PEG) 1500, 29.6% PEG 4000, 5% tween 80, 10% titanium dioxide, and 0.4% acid red 2 offered good protection for coated tablets against moisture. Coated tablets showed physical and dissolution stability during storage. Conclusion: A combination of hydrophilic polymer HPMC and hydrophobic polymer shellac is suitable for balancing moisture-protective properties and attaining the fast release of drugs. This study could make it worthwhile to develop a pharmaceutical moisture barrier film coating system for immediate release tablets. However, more studies will be needed to evaluate the moisture-resistant film further.
Authors: Nazia Uzma; B M Khaja Mohinuddin Salar; B Santhosh Kumar; Nusrat Aziz; M Anthony David; V Devender Reddy Journal: Int J Environ Res Public Health Date: 2008-09 Impact factor: 3.390