Formulation

saedkh's picture

Formulation and Comparative Bioavailability of 2 Ciprofloxacin Sustained Release Tablets

Journal Title, Volume, Page: 
Arzneimittelforschung 2012; 62(07): 319-323 DOI: 10.1055/s-0032-1311609
Year of Publication: 
2012
Authors: 
Zaid AN
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Qaddomi A
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Khammash S.
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

BACKGROUND AND THE PURPOSE OF THE STUDY:

The aim of this study is to formulate and evaluate the quality of ciprofloxacin (CAS number: 85721-33-1) sustained release tablet (Ciprocare®XR) 1 000 mg ciprofloxacin (test formulation) by comparing its pharmacokinetic parameters with Cipro®XR sustained release tablet (reference formulation). For this purpose ciprofloxacin SR tablets were developed using the 2-layer method. To assess the quality of the produced sustained release tablets a randomized, 2-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The selected Middle Eastern volunteers were divided into 2 groups of 12 subjects. One group was treated with the reference formulation and the other one with the test formulation, with a cross-over after a drug washout period of 7 days. Blood samples were collected at fixed time intervals and Ciprofloxacin concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0-48, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both sustained release tablets and were compared statistically to evaluate the bioequivalence between the 2 formulations of ciprofloxacin, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the 2 formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. According to the obtained results it was concluded that the test and reference formulations are bioequivalent, since they exhibit comparable pharmacokinetic parameters.

saedkh's picture

Formulation and Bioequivalence of Two Valsartan Tablets After a Single Oral Administration

Journal Title, Volume, Page: 
Sci Pharm. Mar 2011; 79(1): 123–135. Published online Nov 20, 2010. doi: 10.3797/scipharm.1009-01
Year of Publication: 
2010
Authors: 
Abdel Naser Zaid
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rita Cortesi
Department of Pharmaceutical Sciences, University of Ferrara, ViaFossato di Mortara, 17–19, 44100. Ferrara, Italy
Aiman Qaddomi
Pharmacare Ltd. Beitunia, P.O. Box: 677, Ramallah, Palestine
Saed Khammash
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study is to assess the quality of Valzan® tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan® tablet (160 mg, valsartan reference formulation). Valzan® tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan® tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference formulation (Diovan®) and the other one with the generic Valzan®, with a cross-over after the drug washout period of 14 days. Blood samples were collected at fixed time intervals and valsartan concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0–48, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both the tablets and were compared statistically to evaluate the bioequivalence between the two brands of valsartan, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on this statistical evaluation it was concluded that the test tablets (Valzan®) is well formulated, since it exhibits pharmacokinetic profile comparable to the reference brand Diovan®.

2384's picture

Formulation and Stability Evaluation of 1% W/V Oral Solution ‎of Bromhexine Hydrochloride for Veterinary Use

Journal Title, Volume, Page: 
The Islamic University Journal (Series of Natural Studies and Engineering) Vol.15, No. 1, pp 13 -22
Year of Publication: 
2007
Authors: 
Abdel Naser Zaid
Faculty of Pharmacy, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

Purpose: The aim of this study is to develop bromhexine  hydrochloride 1 %w/v oral solution for veterinary use and to evaluate its  stability. Methods: Solutions of Bromhexine hydrochloride (1%w/v) were  prepared by dissolving bromhexine hydrochloride in benzyl alcohol at 50 °C  then alcohol 96 % v/v; Tween 80 and purified water were added. The obtained  solution was filled in amber glass bottles, and the solution was stored at 25  °C/60 % relative humidity (RH) and at 40 °C /75% RH. The strengths of  bromhexine hydrochloride were determined by High performance liquid  chromatographic assay at 0, 2, 4, 6, 8, 10, 12, 16, 20 and 24 months. The  concentrations of the drug were directly related to the peak area. pH, odor,  color and crystal formation was also monitored. Results: The degradation of  bromhexine hydrochloride 1% w/v oral solution was faster at 40 °C/75% RH  than at 25 °C /60% RH. No significant differences were found between the  initial and final pH value for the solution at the studied conditions. No  detectable changes in color, odor or precipitations were observed for the  solutions stored at the upper conditions. Conclusions: Bromhexine  hydrochloride 1% w/v oral solution could be formulated and remains stable  for at least 2 years when is stored at 25°C /60% RH and for 16 months when  stored at 40 °C /75% RH.  

2384's picture

Compliance of Scored Tablet Halves Produced by Palestinian ‎Pharmaceutical Companies with the New European ‎Pharmacopoeia Requirements

Journal Title, Volume, Page: 
Arch Pharm Res.;34(7):1183-9
Year of Publication: 
2011
Authors: 
Zaid AN
Department of Pharmaceutics and Biopharmaceutics, College of Pharmacy, An-Najah National University, Nablus, P.O. Box 7, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Ghosh AA
Department of Pharmaceutics and Biopharmaceutics, College of Pharmacy, An-Najah National University, Nablus, P.O. Box 7, Palestine
Preferred Abstract (Original): 

The aim of this study was to evaluate the weight uniformity of commonly divided tablets produced by Palestinian Pharmaceutical Companies and to evaluate the importance of both patient- and formulation-related variables on the splitting results. Eighty-four volunteers were enrolled in this study; their age, gender and occupation were documented in order, and the effect of these variables on the tablet splitting results was evaluated. Each volunteer was asked to divide six scored tablets of each product tested and was given clear instructions on how to conduct the splitting process. The split units were individually weighed and the RSD for each product was calculated as instructed in the European Pharmacopoeia (Ph. Eur. 5.5). Only one scored tablet product passed the Ph. Eur. test of mass uniformity, while the remaining 13 products failed; this indicates that the splitting of these tablet products is not a reliable means for the provision of accurate doses to patients. Age, gender and occupation of volunteers were not found to be predictive of any variability noted in the splitting results. The only factors that were suspected to be linked to passing the splitting test, as per the European Pharmacopoeia, were the shape, friability and hardness of the tablets. As a result of this study, we believe that the practice of dividing tablets, which should provide therapeutic and economic benefits for the patient, may potentially cause significant problems, especially in drugs with low therapeutic indices. Tablets produced by Palestinian Pharmaceutical Companies should comply with the new Ph. Eur. splitting regulations to reduce this potential for complications.

2384's picture

Tablet Formulation and Development of a Validated Stability Indicating HPLC Method for Quantification of Valsartan and Hydrochlorthiazide Combination

Journal Title, Volume, Page: 
International Journal of Pharmacy & Pharmaceutical Sciences;Jul2012, Vol. 4 Issue 3,
Year of Publication: 
2012
Authors: 
Abdel Naser Zaid
An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nidal Jaradat
An-Najah National University, Nablus, Palestine
Raqi Shubitah
An-Najah National University, Nablus, Palestine
Murad Abualhasan
An-Najah National University, Nablus, Palestine
Muman Malkieh
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Maher Kharoaf
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Preferred Abstract (Original): 

This study was aimed to develop valsartan/ hydrochlorothiazide tablet formulation and to develop a stability indicating HPLC method for their analysis in raw materials and in its final dosage form according to the ICH guidelines. Film coating tablets containing valsartan and hydrochlorothiazide were developed. A gradient HPLC method was performed; the flow rate was 1.5 ml/min, injected volume 20μL, the mobile phases consist of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 265nm. Valsartan and hydrochlorothiazide and their combined dosage form were exposed to thermal, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of valsartan and hydrochlorothiazide in presence of their degradation products and impurities. The method was linear over the range of 2.5–32μg/mL and 17.5-224μg/mL for valsartan and hydrochlorothiazide respectively. The mean recoveries were 100±2% for valsartan and hydrochlorothiazide respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of valsartan and hydrochlorothiazide in tablet dosage forms.

2384's picture

Formulation and Comparative Bioavailability of 2 Ciprofloxacin ‎Sustained Release Tablets

Journal Title, Volume, Page: 
Arzneimittelforschung ; 62(07): 319-323
Year of Publication: 
2012
Authors: 
Zaid AN
College of Pharmacy, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Qaddomi A
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Khammash S
College of Pharmacy, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study is to formulate and evaluate the quality of ciprofloxacin (CAS number: 85721-33-1) sustained release tablet (Ciprocare®XR) 1 000 mg ciprofloxacin (test formulation) by comparing its pharmacokinetic parameters with Cipro®XR sustained release tablet (reference formulation). For this purpose ciprofloxacin SR tablets were developed using the 2-layer method. To assess the quality of the produced sustained release tablets a randomized, 2-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The selected Middle Eastern volunteers were divided into 2 groups of 12 subjects. One group was treated with the reference formulation and the other one with the test formulation, with a cross-over after a drug washout period of 7 days. Blood samples were collected at fixed time intervals and Ciprofloxacin concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0-48, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both sustained release tablets and were compared statistically to evaluate the bioequivalence between the 2 formulations of ciprofloxacin, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the 2 formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. According to the obtained results it was concluded that the test and reference formulations are bioequivalent, since they exhibit comparable pharmacokinetic parameters.

yabatta's picture

Formulation and Application of the Entomopathogenic Fungus: Zoophthora ‎Radicans (Brefeld) Batko (Zygomycetes; Entomophthorales)‎

Journal Title, Volume, Page: 
Journal of Applied Microbiology, 110: 831–839
Year of Publication: 
2011
Authors: 
Y.A. Batta
Department of Plant Production and Protection, Faculty of Agriculture, An-Najah National University, Palestine.
Current Affiliation: 
Department of Plant Production and Protection,Faculty of Agriculture and Veterinary Medicine, An Najah National University, Nablus, Palestine
M. Rahman
Insect Molecular Biology Laboratory, Department of Applied and Molecular Ecology, School of Agriculture, Food and Wine, Adelaide University, SA, Australia
K. Powis
Entomology Unit, South Australian Research & Development Institute (SARDI), Waite Campus, Glen Osmond, SA, Australia
G. Baker
Entomology Unit, South Australian Research & Development Institute (SARDI), Waite Campus, Glen Osmond, SA, Australia
O. Schmidt
Insect Molecular Biology Laboratory, Department of Applied and Molecular Ecology, School of Agriculture, Food & Wine, Adelaide University, Waite Campus, Glen Osmond, SA, Australia
Preferred Abstract (Original): 

AIMS:

To isolate and formulate a native strain of Zoophthora radicans naturally infecting larvae of diamondback moth, Plutella xylostella, existing in South Australia and to provide evidence that formulation of the fungus is effective against P. xylostella larvae, and therefore, it could be used as a tool in pest management of this insect.

METHODS AND RESULTS:

Dose-response bioassays using formulated and unformulated forms of the fungus strain were carried out against third instar larvae of P. xylostella. Results obtained have indicated a significant increase in the larval mortality when higher concentrations of a formulated form of the fungus strain were applied compared to the treatments with the unformulated form (85·0 vs 57·5% of larval mortality, respectively, at the top concentration of 10(7) conidia/ml). The median lethal concentration (LC50) for a formulated form was 100 times less than that of the unformulated form when they were applied against the third instar larvae of P. xylostella. In addition, the formulation used in the present bioassays has preserved the viability of introduced fungus conidia for longer time in comparison with the unformulated conidia.

CONCLUSIONS:

The effective application of a formulated fungus strain against P. xylostella larvae constitutes the first step towards its use in pest management of this insect.

SIGNIFICANCE AND IMPACT OF THE STUDY:

The formulated fungus in inverted emulsion could be used as an alternative tool to insecticides in pest management of P. xylostella larvae because of the development of resistance to insecticides in the treated larvae.

M_abualhasan's picture

Tablet Formulation and Development of a Validated Stability Indicating HPLC Method for Quantification of Valsartan and Hydrochlorthiazide Combination

Journal Title, Volume, Page: 
SOURCE International Journal of Pharmacy & Pharmaceutical Sciences;Jul2012, Vol. 4 Issue 3, p284
Year of Publication: 
2012
Authors: 
MAHER KHAROAF
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Muman Malkieh
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Murad Abualhasan
An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Raqi Shubitah
An-Najah National University, Nablus, Palestine
Nidal Jaradat
An-Najah National University, Nablus, Palestine
Abdel Naser Zaid
An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 
This study was aimed to develop valsartan/ hydrochlorothiazide tablet formulation and to develop a stability indicating HPLC method for their analysis in raw materials and in its final dosage form according to the ICH guidelines. Film coating tablets containing valsartan and hydrochlorothiazide were developed. A gradient HPLC method was performed; the flow rate was 1.5 ml/min, injected volume 20μL, the mobile phases consist of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 265nm. Valsartan and hydrochlorothiazide and their combined dosage form were exposed to thermal, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of valsartan and hydrochlorothiazide in presence of their degradation products and impurities. The method was linear over the range of 2.5–32μg/mL and 17.5-224μg/mL for valsartan and hydrochlorothiazide respectively. The mean recoveries were 100±2% for valsartan and hydrochlorothiazide respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of valsartan and hydrochlorothiazide in tablet dosage forms.
2384's picture

Formulation and Bioequivalence of Two Valsartan Tablets after a Single Oral Administration

Journal Title, Volume, Page: 
Sci. Pharm. 2011; 79: 123–135
Year of Publication: 
2011
Authors: 
Abdel Naser ZAID
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rita CORTESI
Department of Pharmaceutical Sciences, University of Ferrara, ViaFossato di Mortara, 17–19, 44100. Ferrara, Italy
Aiman QADDOMI
Pharmacare Ltd. Beitunia, P.O. Box: 677, Ramallah, Palestine
Saed KHAMMASH
College of Pharmacy, An-Najah National University, P.O. Box: 7, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study is to assess the quality of Valzan® tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan® tablet (160 mg, valsartan reference formulation). Valzan® tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan® tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference formulation (Diovan®) and the other one with the generic Valzan®, with a cross-over after the drug washout period of 14 days. Blood samples were collected at fixed time intervals and valsartan concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0–48, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both the tablets and were compared statistically to evaluate the bioequivalence between the two brands of valsartan, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on this statistical evaluation it was concluded that the test tablets (Valzan®) is well formulated, since it exhibits pharmacokinetic profile comparable to the reference brand Diovan®.

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