Polypill for the treatment of cardiovascular diseases

Kumar, Vijay; Malik, Satish; Singh, Saranjit

doi:10.1016/j.jpba.2008.06.003

Cited by 20 publications

(7 citation statements)

References 10 publications

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“…( S,S,S )-Diketopiperazine was independently prepared by heating the n-butanol solution of lisinopril in the presence of hydrochloric acid at 80°C. The spectral data of this impurity matched the reported results [ 16 ].…”

Section: Resultssupporting

confidence: 89%

Synthesis and Characterization of Compounds Related to Lisinopril

Reddy¹,

Garaga

Takshinamoorthy

et al. 2016

Sci. Pharm.

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Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class that is primarily used in the treatment of hypertension. During the scale-up of the lisinopril process, one unknown impurity was observed and is identified. The present work describes the origin, synthesis, characterization, and control of this impurity. This paper also describes the synthesis and characterization of three other impurities listed in the European Pharmacopoeia 8.4 (Impurity C, D, and F).

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Section: Resultssupporting

confidence: 89%

Synthesis and Characterization of Compounds Related to Lisinopril

Reddy¹,

Garaga

Takshinamoorthy

et al. 2016

Sci. Pharm.

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“…Such interactions, termed incompatibilities, can be either physical or chemical in nature. Chemical interactions between APIs are well documented for FDCs intended for the treatment of tuberculosis, malaria or CVDs, conditions which usually require combination therapy ( 10 – 15 ). For example, ternary and quaternary drug combinations containing rifampicin and isoniazid along with pyrazinamide and/or ethambutol hydrochloride were very unstable, showing up to 70 or 95% loss of rifampicin or isoniazid, respectively, due to chemical reaction ( 11 ).…”

Section: Introductionmentioning

confidence: 99%

“…For example, ternary and quaternary drug combinations containing rifampicin and isoniazid along with pyrazinamide and/or ethambutol hydrochloride were very unstable, showing up to 70 or 95% loss of rifampicin or isoniazid, respectively, due to chemical reaction ( 11 ). Also, Kumar et al reported incompatibility between polypill ingredients – atenolol, lisinopril, aspirin and statin due to chemical reactions ( 14 , 15 ). Solid-state reactions of API with excipient or API can include: transacylation, Maillard browning reactions and acid–base reactions.…”

Section: Introductionmentioning

confidence: 99%

Bisoprolol and Bisoprolol-Valsartan Compatibility Studied by Differential Scanning Calorimetry, Nuclear Magnetic Resonance and X-Ray Powder Diffractometry

et al. 2014

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PurposeThe objective of this study was to evaluate the thermal behavior of crystalline and amorphous bisoprolol fumarate and its compatibility with amorphous valsartan. This pharmacologically relevant drug combination is a potential candidate for fixed-dose combination formulation.MethodsDSC and TMDSC were used to examine thermal behavior of bisoprolol fumarate. SSNMR and XRPD were applied to probe the solid state forms. The thermal behavior of physical mixtures with different concentrations of bisoprolol and valsartan were examined by DSC and TMDSC, and the observed interactions were investigated by XRPD, solution- and solid-state NMR.ResultsThe phase transitions from thermal methods and solid-state NMR spectra of crystalline and amorphous bisoprolol fumarate are reported. Strong interactions between bisoprolol fumarate and valsartan were observed above 60 C, resulting in the formation of a new amorphous material. Solution- and solid-state NMR provided insight into the molecular nature of the incompatibility.ConclusionsA combined analysis of thermal methods, solution- and solid-state NMR and XRPD experiments allowed the investigation of the conformational and dynamic properties of bisoprolol fumarate. Since bisoprolol fumarate and valsartan react to form a new amorphous product, formulation of a fixed-dose combination would require separate reservoirs for bisoprolol and valsartan to prevent interactions. Similar problems might be expected with other excipients or APIs containing carboxylic groups.Electronic supplementary materialThe online version of this article (doi:10.1007/s11095-014-1471-7) contains supplementary material, which is available to authorized users.

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“…Several studies have been reported on the interaction between ACE inhibitors and NSAIDs [5][6][7][8][9][10][11]. Likewise, there are number of possible drug interactions of lisinopril with NSAIDs [12][13][14][15].The study of potential drug interactions of lisinopril with various NSAIDs requires the quantitation of both of these drugs in various samples containing both of these types of drugs. A number of RP-HPLC methods are reported for the determination of lisinopril in dosage forms and spiked human plasma through derivatization [16] and in human plasma with fluorescence detection [17].…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method for the Simultaneous Determination of Lisinopril and NSAIDs in API, Pharmaceutical Formulations and Human Serum

Sultana¹,

Arayne²,

Siddiqui³

et al. 2012

AJAC

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High performance liquid chromatographic method was developed valdated and applied for the simultaneous determi- nation of lisinopril and NSAIDs in bulk, pharmaceuticals formulations and human serum. A Purospher star C18 (5 µm, 25 × 0.46 cm) column was used with mobile phase consisting of methanol: water: acetonitrile (80:17.5:2.5 v/v, pH 3.0) and quantitative evaluation was performed at 225 nm with a flow rate of 1.0 mL?min–1. The retention time of lisinopril was 2.2 min while naproxen, flurbiprofen, diclofenac sodium and mefenamic acid were found to be 4.0, 4.5, 5.0 and 6.7 min respectively. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines. The method is selective, precise, accurate and can be used for analysis of pharmaceutical preparations in quality control and clinical laboratories

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Polypill for the treatment of cardiovascular diseases

Cited by 20 publications

References 10 publications

Synthesis and Characterization of Compounds Related to Lisinopril

Synthesis and Characterization of Compounds Related to Lisinopril

Bisoprolol and Bisoprolol-Valsartan Compatibility Studied by Differential Scanning Calorimetry, Nuclear Magnetic Resonance and X-Ray Powder Diffractometry

RP-HPLC Method for the Simultaneous Determination of Lisinopril and NSAIDs in API, Pharmaceutical Formulations and Human Serum

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