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A COMPARATIVE DISSOLUTION STUDY OF COMBINATION DOSE OF PARACETAMOL (500mg) AND IBUPROFEN (200 mg): FORMULATION ASPECTS OF SOLID DOSAGE FORMS AVAILABLE IN BANGLADESH

Journal: Indo American Journal of Pharmaceutical Sciences (IAJPS) (Vol.04, No. 02)

Publication Date:

Authors : ; ; ; ; ; ; ; ; ; ;

Page : 312-326

Keywords : Formulation approach of dosages regimen; Parameters testing; In vitro release; Comparative dissolution profile; Treatment indication; Commercial approach.;

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Abstract

This paper reports a study has been designed to formulate and to offer a comparison of various parameters of combination dose of Paracetamol (500 mg) and Ibuprofen (200 mg). A combined solid dosage form of Paracetamol (500mg) and Ibuprofen (200mg) is formulated and tested by analytical parameters.We use Nuromol (Paracetamol 500 mg and Ibuprofen 200 mg; Reckitt Benckiser Healthcare, UK) as a vendor drug for the purpose to cure from mild to moderately severe pain as a new combination dosage regimen in Bangladesh. Initially combined dosage regimen was prepared using six different formulas and formulated drugs are tested for checking all parameters as with supplied reference drugs. The assay is carried out by employing HPLC system with UV detection at 222 nm.There after each formulation had been subjected to preformulation and postformulation studies. The tablet mass is evaluated by assessing various compressional parameter such as angle of repose, bulk density, tapped density, Hausner's ratio and compressibility index. All the results are met the specifications and this results indicated that this new formulation have good flow properties. Various kinetic models were employed for the application of in vitro release profile assessment. The hardness of the tablet is found 4.3 to 6 kg, friability of the tablet is found 0.25 to 0.63%, disintegration time for the core tablet and the coated tablet are found 40 seconds and 1.30 seconds respectively. The results also show that the presence of active components in the formulated tablets are 100.31% Paracetamol and 101.12% Ibuprofen. We observed the potencies of the Paracetamol are 103.36% and 99.29% for Ibuprofen. All results of post formulation parameters were according to pharmacopoeias and within acceptable range. Based on fundamental comparative behavior of drug dissolution it can be concluded that release profile of all six batches under investigation was compatible with reference drug. In this present study as the newly formulated combination dosages regimen has met all the acceptance criteria and complied with the pharmacopoeial specifications and reference standard this formulation can be adapted as commercial preparation in Bangladesh for treatment of mild to moderately severe pain for post-operative patients. Key words: Formulation approach of dosages regimen, Parameters testing, In vitro release, Comparative dissolution profile, Treatment indication, Commercial approach.

Last modified: 2017-03-11 23:02:13