Development of a Dissolution Method to Compare Tablet Formulations Containing Valsartan/Amlodipine

ObjectivesThe objectives of this study were to evaluate the general quality of the most prescribed products of valsartan (VL; alone or in combination) and to evaluate their efficacy and safety among Palestinian population through in vivo postmarketing surveillance.Patients and methodsThe first part was pharmacopeial quality control assay, including dissolution, disintegration, friability, and weight uniformity for VL. The second part was a 3-month cardiology clinics, observational, postmarketing surveillance pilot study that included 103 hypertensive patients who were prescribed 80 mg or 160 mg of VL as monotherapy or combination therapy. The end points were reduction in blood pressure (BP) and the rate of incidence of adverse effects (AEs) at weeks 4 and 8.ResultsAccording to our quality control tests, all VL products showed high-quality standards according to the international guidelines. A reduction in BP was observed at weeks 4 and 8, and no significant difference was observed between the strengths of 80 mg and 160 mg. Higher BP reduction was observed after the use of combination therapy. Moreover, VL was well tolerated; most of the AEs were of mild-to-moderate intensity. In general, the most frequently reported AEs included headache (17.5%), dizziness (11.75%), and weakness (11.7%). No serious AEs or death cases were reported during the study period.ConclusionHigh quality of VL tablet products was used; hence, the observed efficacy and safety results should be related to patient’s factors and not due to any product defects or substandard quality. Moreover, VL is an effective treatment for essential hypertension.

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“…An f 1 value >15 indicates significant dissimilarity, and an f 2 value >50 indicates significant similarity. 20 – 23…”

Section: Methodsmentioning

confidence: 99%

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Zaid

Ghanem²,

Shweiki

et al. 2016

TCRM

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“…f1 value greater than 15 indicates significant dissimilarity, and an f2 value greater than 50 indicates significant similarities 15 .…”

Section: Dissolution Profile Comparison Using F1 and F2mentioning

confidence: 99%

Untitled

2018

IJPSR

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Buckwheat has been a major food source in Asian countries such as China, Japan, and Bhutan etc. for its nutritional values. It has been a major functional food supplement for nutraceutical industry. It is the first time exploration of buckwheat seed powder as tablet binder. The aim the study was to expand the area off tablet binders from gums and extracted polysaccharides to whole seed powders so as to reduce processing cost involved with other synthetic binders and involvement of whole seed benefits to single dosage form. In the present study buckwheat seed powder was used in the concentrations of 1%, 2%, 4%, 6% and it was compared with binding capacity of 2.5% acacia in tablet formulation as direct compressible agent. Valsartan was used as a model drug. It was found out that 2% w/w concentration of Buckwheat seed powder performed well and all the parameters were in good range. It was concluded that buckwheat seed powder can be a good direct compressible agent for tablet formulation.

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“…Valsartan is an angiotensin II type 1 receptor antagonist; it is rapidly absorbed, reaching the maximum plasma level 3 h after oral administration [1]. Valsartan has low bioavailability of 25 % and pH-dependent solubility as its solubility decreases in low pH conditions such as the acidic environment of the upper gastrointestinal tract [2].…”

Section: Introductionmentioning

confidence: 99%

Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

Kim¹,

Kim²,

Kang³

2016

Asian J. Chem.

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Design of experiment provides a quality risk management to the manufacturing process of a product. This study was performed to select the water amount and identify the critical process parameters for wet granulation. Design of experiment, one of the quality by design approaches, was used in the study. The manufacturing process of valsartan and paravastatin fixed-dose combination tablets involves wet granulation, drying, sieving, blending and tableting. For wet granulation, a 3-factorial (granulating time, agitator speed and the amount of granulating water), 2-level (granule density and dissolution), 1-center (n = 3) point was used in the design of experiment batches and analyzed using Design Expert Software. Previously, this formulation was found to show good assay and content uniformity. Thus, only physical properties, bulk density and dissolution were evaluated for the design of experiment study. The amount of granulating water was identified as an important factor affecting the mean dissolution (p < 0.05) in contrast to the granulating time and agitator speed. Present results indicated that granulating time (6 to 10 min), amount of granulating water (40 to 60 g) and agitator speed (150 to 250 rpm) were optimal for wet granulation of valsartan and pravastatin fixed-dose combination tablets.

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Development of a Dissolution Method to Compare Tablet Formulations Containing Valsartan/Amlodipine

Cited by 6 publications

References 14 publications

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Untitled

Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

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