Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2019
Novel sublingual tablets of Atorvastatin calcium/Trimetazidine hydrochloride combination; HPTLC quantification, in vitro formulation and characterization.
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Atia Noha N, Tawfeek Hesham M, Rageh Azza H, El-Zahry Marwa R, Abdelfattah Ahmed, Younis Mahmoud A
Аннотация
BACKGROUND: Ischemic heart disorders and accumulation of lipids in blood vessels could contribute to angina pectoris. Therefore, the aim of this study was to formulate sublingual tablets containing a novel combination of Atorvastatin calcium (ATOR) and Trimetazidine HCl (TMZ) for efficient treatment of coronary heart disorders.
METHODS: The dissolution rate of water-insoluble ATOR was enhanced via complexation with sulfobutyl ether-β-cyclodextrin (SBE-β-CD) and addition of soluplus as a polymeric solubilizer excipient. The solubilized ATOR and TMZ were compressed into a sublingual tablets by direct compression technique and evaluated for their tableting characteristics. In addition, a new validated method based on High Performance Thin Layer Chromatography (HPTLC) was developed for simultaneous determination of both drugs in pure forms and sublingual tablets.
RESULTS: The developed HPTLC method showed LODs of 0.056 and 0.013 μg/band and LOQs of 0.17, 0.040 μg/band for TMZ and ATOR, respectively and proved to be linear, accurate, precise and robust. The optimum formulation containing mixture of superdisintegrants; Ac-Di-Sol and crospovidone (4.8% w/w, each) showed the shortest disintegration time (65 s) and enhanced release profiles of both drugs.
CONCLUSIONS: The prepared sublingual tablets combining ATOR and TMZ will be a promising dosage form for coronary heart disease patients with an instant action and improved patient compliance.
METHODS: The dissolution rate of water-insoluble ATOR was enhanced via complexation with sulfobutyl ether-β-cyclodextrin (SBE-β-CD) and addition of soluplus as a polymeric solubilizer excipient. The solubilized ATOR and TMZ were compressed into a sublingual tablets by direct compression technique and evaluated for their tableting characteristics. In addition, a new validated method based on High Performance Thin Layer Chromatography (HPTLC) was developed for simultaneous determination of both drugs in pure forms and sublingual tablets.
RESULTS: The developed HPTLC method showed LODs of 0.056 and 0.013 μg/band and LOQs of 0.17, 0.040 μg/band for TMZ and ATOR, respectively and proved to be linear, accurate, precise and robust. The optimum formulation containing mixture of superdisintegrants; Ac-Di-Sol and crospovidone (4.8% w/w, each) showed the shortest disintegration time (65 s) and enhanced release profiles of both drugs.
CONCLUSIONS: The prepared sublingual tablets combining ATOR and TMZ will be a promising dosage form for coronary heart disease patients with an instant action and improved patient compliance.