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A new dosage form of Trinitroglycerin (TNG) in the form of microcapsules, yet unreported in the literature, was developed at our laboratory. This formulation is expected to overcome the problem of volatility and instability of TNG. This study was conducted in two parts. In the first part, the formulation of microcapsules of Nitroglycerin was accomplished along with recovery procedures from which a suitable recovery method was developed (lyophilization). In the second part stability studies were conducted under high vacuum (< 1 mM Hg), and various conditions of temperature and humidity. A sensitive HPLC method that allows the separation of Nitroglycerin and its major degradation products was developed which proved to be an excellent stability indicating assay for TNG in dosage forms. The microencapsulated dosage form of TNG was found to be an excellent method to stabilize the drug when stored at low temperature under anhydrous conditions. Further studies will be carried out on the stability behaviour of compressed tablet dosage form of microencapsulated TNG.
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