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Rajesh Asija ¹, Shailendra Bhatt ¹, Sangeeta Asija ¹, Isha Shah ¹, Alpesh Yadav ¹

Affiliations
1 Maharishi Arvind Institute of Pharmacy, Mansarovar, Jaipur, 302020, IN

Abstract

Aim of the present study is to improve solubility of nebivolol by different technological approaches during the pharmaceutical product development. Solid dispersion technique using wide variety of carriers such as PEG 6000 and PVP K30 were prepared in ratio 1:1, 1:3 and 1:5 by fusion and solvent evaporation method. All the solid dispersions were evaluated for drug content, phase solubility, in vitro dissolution study. Solubility of PEG 6000 and PVP K30 indicates a linear relationship (A_L type of curve) in the investigated polymer concentration range. The Gibb's free energy showed declined trend with increase in the carrier concentrations. Different drug-carrier concentration level fitted to different kinetic model and it was found that solid dispersions exhibited fickian diffusional characteristics and best fitted to Higuchi model. A PVP K30 solid dispersion (1:5 ratio) prepared by solvent evaporation method showed faster dissolution rate (93.31 %) in 30 min among studied solid dispersions. The overall results showed that process of nebivolol transfer from water to carrier solution is more favorable at higher level of PVP K30. The solid dispersion of drug: PVP K 30 (1:5 ratio) prepared by solvent evaporation method was found to be optimum in term of solubility and dissolution rate. Hence, we can concluded that solubility of nebivolol can be enhanced using this carrier ratio.

Keywords

Nebivolol, Solid Dispersion, Fusion Method, Solvent Evaporation Method, PEG 6000, PVP K30.

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Priti Trivedi ¹, Shailendra Bhatt ²

Affiliations
1 K.B. Institute of Pharmaceutical Education and Research, Gandhi nagar. (Gujarat), IN
2 Sardar Patel College of Pharmacy, Bakrol, Anand. (Gujarat), IN

Abstract

Fast dissolving tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. This review describes various formulations and technologies developed to achieve fast dissolution/dispersion of tablets in the oral cavity, along with excipients, evaluation test, marketed formulation, and drugs explored in this field.

Keywords

Disintegrants, Fastdissolving Tablets, Superdisintegrants.

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Chinmoy Kumar ¹, Manish Kumar ¹, Vipin Saini ², Shailendra Bhatt ¹, A. Pandurangan ¹, Anuj Malik ¹, Preeti Pal ¹, Laxmi Narayan Shetty ³

Affiliations
1 M M College of Pharmacy, Markandeshwar (Deemed to be University), Mullana, Ambala-133207, Haryana, IN
2 M M University, Solan, Himachal Pradesh, IN
3 Reginal Drugs Testing Laboratory, Ballari, Karnataka, IN

Abstract

The combination tablets dosage form of Telmisartan and Nebivolol hydrochloride dissolution method was developed by UV spectrophotometer and validated was according to the ICH guidelines. The any official method of this combination drugs was not available. In this proposed method two commercial brands of drug was used. The simultaneous estimation of Telmisartan and Nebivolol hydrochloride was performed in this proposed method which includes to solving of simultaneous equation. The wavelength of Telmisartan 296nm and 281nm of Nebivolol hydrochloride was used in this simultaneous equation. The dissolution mediums such as 0.1N HCl, phosphate buffer, SFG (without enzyme) at various ph was used in this method. The selected proposed dissolution method was SFG dissolution media (without enzyme) 900 ml, speed 75 rpm, USP type II apparatus and temperature at 37 ± 0.5°C and drug release than 85% within 45mints. The optimized proposed method easy to handle and commercially used for the routine quality control checking of Telmisartan and Nebivolol hydrochloride pharmaceutical combine tablets dosage form.

Keywords

Telmisartan, Nebivolol Hydrochloride, Simultaneous Equation, Dissolution, Validation, ICH Guidelines.

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Jai Bharti Sharma ¹, Shailendra Bhatt ¹, Vipin Saini ², Rupesh K. Gautam ³, Manish Kumar ¹

Affiliations
1 MM College of Pharmacy, MM (Deemed to be) University, Mullana, Ambala, Haryana,, IN
2 MM School of Pharmacy, MM University, Sadopur, Ambala, Haryana,, IN
3 Maharishi Markandeshwar University, Solan, HP,, IN

Abstract

Background: Curcumin shows degradation in the solution of high pH. There is a need for development of a method which can estimate the drug release precisely and accurately. The UV spectroscopy due to its simplicity and specificity is the most popular for method development for the determination of drugs. Objective: The present study was aimed to develop the UV-Visible spectrophotometric method for the assessment of curcumin and tetrahydrocurcumin (THC) using a stable solvent system. Method: The solubility of curcumin and tetrahydrocurcumin was determined at various physiological pH levels. Non-ionic surfactant, tween 80 was used with selected media to avoid the degradation of drugs. The selected solvent system was further validated according to guidelines of the international conference on harmonization (ICH) and the analytical parameters like linearity, veracity, sensitivity and accuracy were studied. Results: The solvent systems Phosphate buffer of pH 6.8+2% tween 80 and Phosphate buffer of pH 6.8+1% tween 80 were found optimum for estimation of curcumin and THC respectively. All the validation parameters were found within the range for developed methods. Conclusion: The proposed method is very simple and can be used for routine quality control testing of curcumin and tetrahydrocurcumin.

Keywords

Curcumin, Tetrahydrocurcumin, Phosphate buffer pH 6.8, Tween 80, UV-Visible spectrophotometric method development.

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