Stability

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Comparative fasting bioavailability of two clopidogrel formulations in healthy Mediterranean volunteers: an in vitro–in vivo correlation

Journal Title, Volume, Page: 
rug Design, Development and Therapy 24(9):2359-65 · April 2015
Year of Publication: 
2015
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
Rowa Ramahi
Department of Pharmacy, Faculty of Medicine and health sciences, An-Najah National University, Nablus, Palestine
Rana Bustami
Pharmaceutical Research Unit, Amman, Jordan
Ayman Mousa
R&D Department, Middle East Pharmaceutical Industries Co Ltd, Riyadh, Saudi Arabia
Sewar Khasawneh
Pharmaceutical Research Unit, Amman, Jordan
Preferred Abstract (Original): 
OBJECTIVE:
The aim of this study was to evaluate the bioequivalence of two drug products, generic clopidogrel bisulfate 75 mg film-coated tablets versus the reference Plavix(®) clopidogrel bisulfate 75 mg film-coated tablets.
METHODS:
Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki, the current Good Clinical Practice Guidelines, and the International Conference on Harmonization.
RESULTS:
The relationship between concentration and peak area ratio was found to be linear within the range 24.500-1,836.600 pg/mL for clopidogrel. The correlation coefficient (r) was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. The point estimates (ratios of geometric mean) were 104.122%, 104.184%, and 109.091% for areas under the plasma concentration-time curve (AUC) AUC0-last, AUC0-∞, and peak plasma concentration C max, respectively. These pharmacokinetic parameter values of clopidogrel and its main metabolite lie within the bioequivalence limit (80%-125%) specified by the US Food and Drug Administration and the European Medicines Agency.
CONCLUSION:
The tested drug product was bioequivalent to the reference drug under fasting conditions and had the same safety profile, which is important to achieve equivalent therapeutic effect with the reference.
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Medicinal Herbs and Methodologies for Their Pharmaceutical Compounding In the West Bank/Palestine

Journal Title, Volume, Page: 
Complementary Therapies in Clinical Practice 01/2014; DOI: 10.1016/j.ctcp.2014.06.001
Year of Publication: 
2014
Authors: 
Rowa' Al-Ramahi
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nidal Jaradat
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
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
Franco Francesco Vincieri
Department of Pharmaceutical Sciences, University of Florence Polo Scientifico dell'Università, Italy
Mays Asmaa
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study was to carry an ethnopharmacological survey on medicinal herbs and the methodology used in extraction of active compounds. A survey study was carried out; it included herbalists, herbal shops and people who are involved in traditional Arabic medicine. For each disease included, informants were asked to list plants used, the used part from which the products were prepared as well as the method of preparation. A total of 109 plants were identified. Within the plants used, leaves (47.3%), fruits (18.5%) and seeds (18.0%) were the plant parts most widely used. Methods of preparation were mainly decoction (boiling) by 51%, and then infusion (drenching) by 17%. Some plants were prepared as creams, powders, syrups, added to food or cooked. Many plant species are still used by herbalists in our country for treating various human diseases and ailments. Most plants are prepared by boiling, which may cause degradation of active ingredients. Preparations should take into consideration the stability of the active ingredients.

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Medicinal Herbs and Methodologies for Their Pharmaceutical Compounding In the West Bank/Palestine

Journal Title, Volume, Page: 
Complementary Therapies in Clinical Practice 01/2014; DOI: 10.1016/j.ctcp.2014.06.001
Year of Publication: 
2014
Authors: 
Rowa’ Al-Ramahi
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nidal Jaradat
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
Abdel Naser Zaid
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Franco Francesco Vincieri
Department of Pharmaceutical Sciences, University of Florence Polo Scientifico dell'Università, Italy
Mays Asmaa
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study was to carry an ethnopharmacological survey on medicinal herbs and the methodology used in extraction of active compounds. A survey study was carried out; it included herbalists, herbal shops and people who are involved in traditional Arabic medicine. For each disease included, informants were asked to list plants used, the used part from which the products were prepared as well as the method of preparation. A total of 109 plants were identified. Within the plants used, leaves (47.3%), fruits (18.5%) and seeds (18.0 %) were the plant parts most widely used. Methods of preparation were mainly decoction (boiling) by 51%, and then infusion (drenching) by 17%. Some plants were prepared as creams, powders, syrups, added to food or cooked. Many plant species are still used by herbalists in our country for treating various human diseases and ailments. Most plants are prepared by boiling, which may cause degradation of active ingredients. Preparations should take into consideration the stability of the active ingredients.

Rowa Al Ramahi's picture

Medicinal Herbs and Methodologies for Their Pharmaceutical Compounding In the West Bank/Palestine

Journal Title, Volume, Page: 
Complementary Therapies in Clinical Practice 01/2014; DOI: 10.1016/j.ctcp.2014.06.001
Year of Publication: 
2014
Authors: 
Rowa' Al-Ramahi
Department 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
Nidal Jaradat
Department of Pharmacy, An-Najah National University, Nablus, Palestine
Abdel Naser Zaid
Department of Pharmacy, An-Najah National University, Nablus, Palestine
Franco Francesco Vincieri
Department of Pharmaceutical Sciences, University of Florence Polo Scientifico dell'Università, Italy
Mays Asmaa
Department of Pharmacy, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study was to carry an ethnopharmacological survey on medicinal herbs and the methodology used in extraction of active compounds. A survey study was carried out; it included herbalists, herbal shops and people who are involved in traditional Arabic medicine. For each disease included, informants were asked to list plants used, the used part from which the products were prepared as well as the method of preparation. A total of 109 plants were identified. Within the plants used, leaves (47.3%), fruits (18.5%) and seeds (18.0%) were the plant parts most widely used. Methods of preparation were mainly decoction (boiling) by 51%, and then infusion (drenching) by 17%. Some plants were prepared as creams, powders, syrups, added to food or cooked. Many plant species are still used by herbalists in our country for treating various human diseases and ailments. Most plants are prepared by boiling, which may cause degradation of active ingredients. Preparations should take into consideration the stability of the active ingredients.

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Enhancement of n-Gaas Characteristics by Combined Heating, Cooling Rate And Metalloporphyrin Modification Techniques

Journal Title, Volume, Page: 
Solid State Sciences Volume 6, Issue 1, Pages 139-146
Year of Publication: 
2004
Authors: 
Raqi Shubeita
Faculty of Science, An-Najah N. University, PO Box 7, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Iyad Saadeddin
Faculty of Science, An-Najah N. University, PO Box 7, Nablus, Palestine
Hikmat S.Hilal
Faculty of Science, An-Najah N. University, PO Box 7, Nablus, Palestine
Wajdy M. Ateereh
Faculty of Science, An-Najah N. University, PO Box 7, Nablus, Palestine
Taleb Al-Tel
Faculty of Science, An-Najah N. University, PO Box 7, Nablus, Palestine
Guy Campet
ICMCB-CNRS, 87, av. du Dr. A. Schweitzer, 33608, Pessac cedex, France
Preferred Abstract (Original): 

Different modification techniques, namely, preheating, controlling the cooling rate and modification with tetra(-4-pyridyl)porphyrinatomanganese(III) have been used to enhance photoelectrochemical characteristics of n-GaAs electrodes in light-to-electricity conversions. Combination of such three techniques together yielded electrodes with better darkcurrent density vs potential plots and photocurrent density vs potential plots. Higher efficiency and stability were also observed for electrodes modified by such combined techniques.


Enhancement of n-GaAs characteristics by combined heating, cooling rate and metalloporphyrin modification techniques

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.  

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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.

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Formulation and Evaluation of the Chemical Stability of Povidone-Iodine in Some Trademarks ‎Cleaning Formulations

Journal Title, Volume, Page: 
Int J Pharm Pharm Sci. ; 5(1): 46-48
Year of Publication: 
2013
Authors: 
Abdel Naser Zaid
Department of Pharmacy, College 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): 

Purpose: The aim of this study is to evaluate the chemical stability of Povidone-Iodine (PVP-I) after its incorporation into commercial cleaning formulations. Method: PVP-I was incorporated into five different trademarks of cleaning formulation designated F1through F5. Chemical stability of PVP-Ion months 0,1,2,3 and 4 was checked. pH, color, smell, and foam properties of the obtained cleaning formulations were tested. Results: PVP-I in Shampoo (F1) and hair & body wash (F2) was stable for more than 4 months, while in the shower gel (F3) and liquid soap (F4) was stable within the limit period of three month. The body wash (F5) was stable for only one month. The pH of the formulations remains constant during the entire period of the study. The foam volume and stability was comparable to that obtained from the starting trademarks. No change in smell or color of the cleaning formulations was observed. No sign of precipitate was observed within the entire period of study. Conclusion: Compounding PVP-I into cleaning trademarks in order to achieve disinfection and medical benefits can be followed. Cleaner industries should take seriously in consideration this issue to improve their selling.  

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A Validated and Stability Indicating HPLC Method for Analysis of Diminazene Aceturate and‎ Antipyrine Combination in a Ready Injectable Solution

Journal Title, Volume, Page: 
Drug Res (Stuttg).; 63(6): 300-4.
Year of Publication: 
2013
Authors: 
A. N. Zaid
Department 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
M. N. Abualhasan
Department of Pharmacy, An-Najah National University, Nablus, Palestine
N. Batrawi
Advanced Veterinary Company, Ramallah, Palestine
D. G. Watson
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Preferred Abstract (Original): 

Diminazene aceturate and Antipyrine combination therapy is widely used in veterinary medicine. A simple reverse HPLC method for the analysis of samples of a ready injectable formulation containing a mixture of active ingredients and inactive excipients has been developed. The HPLC analysis was carried out using a reversed phase (RP)-C18 (250 mm×4.0 mm, 5 μm) column. The isocratic mobile phase consisted of a mixture of acetonitrile, methanol, phosphate buffer and hexane sulfonate; the flow rate was 0.6 mL/min and ultraviolet detection was at 291 nm. This method was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method could be used for purity and degradation evaluation of these formulations.

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Terminal Olefin Isomerization Reactions Catalyzed by Poly(Siloxane)-Supported Ru3(CO)12: The Effect of The Support on the Catalyst Selectivity, Activity and Stability

Journal Title, Volume, Page: 
Al-Azhar University Journal, Gaza, Vol. 1, No. 1, 1-21
Year of Publication: 
1999
Authors: 
Shukri Khalaf
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Hikmat S. Hilal
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Mohammad A. Sulaiman
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Waheed J. Jondi
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Moayyad Massoud
Department of Chemistry, Faculty of Science, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

Dodecacarbonyltriruthenium(0), Ru3(CO)12, 1, has been chemically anchored to the aminated polysiloxane surface, 2. The resulting supported ruthenium complex, 3, was evaluated as catalyst for the olefin isomerization reactions. Contrary to its homogeneous catalyst counterpart, 1, the supported catalyst 3 showed exceptionally high selectivity towards 1-octene isomerizationand trans-2-octene was the sole product of the reaction mixture. The olefin isomerization reaction was markedly activated by the presence of the tertiary silane (EtO)3SiH. No hydrosilylation reaction products were detected. Preliminary kinetic study indicated catalysis by lower nuclearity catalytic species, where the cluster fragments during the reaction process. The effects of different reaction parameters on the rate of the reaction have been investigated.
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