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Article
Factors Affecting the Formulation of Carbamazepine Extended Release Tablet

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Abstract

Carbamazepine is an anticonvulsant agent which acts on the central nervous system and used for the treatment of epilepsy. Carbamazepine was formulated as an oral extended release tablets using ethyl cellulose as retardant substance. Different types of tablets additives such as cellulose materials (sodium carboxymethyl cellulose and microcrystalline cellulose ), lactose, calcium phosphate and solubilizing agents ( sodium lauryl sulphate and polyethylene glycol 6000) were utilized to study their effect on the release profile of drug from ethyl cellulose matrices. It was found that sodium carboxymethyl cellulose increased the carbamazepine release and the same effect was obtained when the same amount of microcrystalline cellulose used. The result also showed that sodium lauryl sulphate greatly enhanced the release of the drug compared to polyethylene glycol 6000. Also incorporating lactose led to an increase in the release of the drug while utilization of calcium phosphate slowed down the release of the drug. The results of this study revealed that formula which composed of 4% ethyl cellulose, 5% sodium carboxymethyl cellulose, as well as 25.6% of lactose and 1% magnesium stearate is comply with United State Pharmacopea XXVIII and showed best release profile comparable to that of the brand product Tegretol CR¬¬¬¬®. The shelf life was 3.6 years for the selected formula.

كاربامازبين هو عامل مضاد للاختلاج يعمل على الجهاز العصبي المركزي ويستعمل لمعالجة الصرع. لقد تم تصييغ كاربامازبيين كحبوب فموية ممتدة التحرر باستخدام اثل سليلوز كمادة مثبطة للتحرر. تم استخدام انواع مختلفة من المواد المضافة للحبوب مثل المواد السليلوزية( كاربوكسي مثل سيليلوز الصوديوم والسليلوز مجهري التبلور ) ، لاكتوز ، فوسفات الكالسيوم ، والمواد المحفزة للذوبان( لوريل سلفات الصوديوم وبولي اثيلين كلايكول 6000 ) لتقييم تأثير هذه المواد على شكل تحرر الدواء من قوالب اثل سليلوز. لقد وجد ان الصوديوم كاربوكسي مثل سليلوز يزيد من تحرر الكاربامازبيين ونفس التأثير على التحرر قد وجد عند استخدام نفس الكمية من السليلوز مجحهري التبلور . اضهرت النتائج ايضا ان اللوريل سلفات الصوديوم حفز بشكل كبير تحرر الدواء مقارنة مع بولي اثلين كلايكول 6000 . لقد وجد ان اضافة اللاكتوز يؤدي الى زيادة اكبر من تحرر الدواء بينما استخدام فوسفات الكالسيوم قلل من تحرر الدواء. كشقت نتائج هذه الدراسة ان الصيغة المكونة من % 4 اثل سليلوز و %5 كاربوكسي مثل سليلوز الصوديوم، بالاضافة الى %2.5 لاكتوز و %1 ستيارات الصوديوم تتطابق مع دستور الأدوية الامريكي واعطت افضل شكل تحرر يمكن مقارنته مع المنتج القياسي تكريتول. ثابت التحلل للصيغة المنتجة هو 4.95 × -4 10 اسبوع-1 وعمر الرف 3.6 سنة.


Article
EFFECTS OF CYTOCHROME P-450 INDUCER AND INHIBITOR ANTIEPILEPTIC DRUGS ON LIPID PROFILE IN NORMAL AND DIABETIC RABBITS

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Abstract

Background: Anticonvulsants drugs are a diverse group of pharmacological agents used in the treatment of epileptic seizures are known to inhibit or activate cytochrome p-450 enzymes that play a crucial rule in the metabolic process.Objective:To investigate any possible differences in the effect of antiepileptic drugs; enzyme inducer (carbamazepine) and enzyme inhibitor (lamotrigine) on lipid profile in normal and diabetic rabbits depending on its effect on cytochrome p-450 enzymes.Methods:Fifty four healthy domestic rabbits of both sexes weighing 0.5-2.5 kg were studied. They were divided into group A (standard) received tolamatrigine and carbamazepine without induction of diabetes and group B (received the same regimen) with induction of diabetes. Lipid profile was tested in the two groups. Results: Carbamazepine-treated group showed a significant increase in the lipid profile at day 20 of treatment compared to day 5 in comparison with induced and non-induced control groups and control group in normal and diabetic rabbits. Lamotrigine showed less effect on lipid profile; and in non-diabetic treated groups it showed a non-significant change in lipids level as compared to the control group.Conclusions:Anti-epileptics drugs that possess an enzyme inducing effect as carbamezpin tend to induce high lipids profile in comparison to lamotigine.Keyword: Lamotrigine, carbamazepine, anticonvulsants, glucose, lipid.


Article
Effect of carbamazepine and valproic acid monotherapy on thyroid function tests in epileptic patients

Authors: Imad A. Thanoon عماد عبد الجبار ذنون --- Ashraf H. Ahmed اشرف هاشم احمد
Journal: Annals of the College of Medicine Mosul مجلة طب الموصل ISSN: 00271446 23096217 Year: 2006 Volume: 32 Issue: 1&2 Pages: 57-62
Publisher: Mosul University جامعة الموصل

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Abstract

Objectives: This study was conducted to assess the effect of carbamazepine (CBZ) and sodium valproate (VPA), as a monotherapy in epileptic patients, on thyroid function tests as assessed by serum total triiodothyronine (TT3), total thyroxine (TT4) and thyroid stimulating hormone(TSH).
Subjects and methods: Sixty three epileptic patients using monotherapy were included in the study. These included 44 patients using CBZ and 19 using VPA. A control group of 47 apparently healthy individuals were also included in the study for comparison. Measurement of TSH, TT3 and TT4 was done using Gamma counter.
Results: The results of this study revealed that patients on CBZ showed significantly decreased mean level of TT4 in comparison with the control group (P<0.01), while mean TT3 and TSH levels showed statistically insignificant differences from the control group (P>0.05). In the VPA group, mean TT3, TT4 and TSH values showed insignificant differences from the control group (P>0.05).
Conclusion: Unlike VPA, CBZ significantly decreases level of TT4 without affecting TT3 and TSH levels.

Keywords: Carbamazepine, sodium valproate, thyroid function tests.


Article
Phenylthiocarbamide perception in epileptic patients on carbamazepine therapy

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Abstract

The present study was designed to study the taste sensitivity to phenylthiocarbamideamong epileptic patients. A total of ٧٣ epileptic patients participated in the study. Theepileptic state of the patients was well controlled by carbamazepine therapy, withtheir serum level of carbamazepine within therapeutic range. The other groupconsists of ٦٢ healthy volunteers, serving as a control. Test strips impregnated withphenylthiocarbamide have been used to identify tasters from non tasters of bothpatients and control groups. The individuals who perceive phenylthiocarbamide asbitter tasting was regarded as tasters while those describe it as tasteless were regardedas non-tasters. The results showed no significant difference with regard perception ofphenylthiocarbamide between epileptic patients on carbamazepine therapy andcontrols.

صممت الدراسه لمعرفة حساسية تذوق طعم مادة الفنايل ثايوكاربامايد بين المرضى الذين يعانون من الصرع. شارك في هذه الدراسه 73 مريضا يعانون من الصرع والذين يستخدمون عقار الكارباميزابين, وفد بين قياس تركيز عقار الكارباميزابين في مصل الدم بان تركيز العقار يقع في المجال العلاجي . وقد شارك في الدراسة ايضا 62 متطوعا من الاصحاء كمجموعة ضبط. استخدم في الدراسه شريط اختبار مشرب بمادة الفنايل ثايوكاربامايد لمعرفة الذائق والغير الذائق في مجموعتي المرضى والضبط, الافراد الذين يدركون الفنايل ثايوكاربامايد كطعم مر ,يعتبرون ذائقون بينما الذين يصفون الفنايل ثايوكاربامايد لاطعم لديه يعتبرون غير ذائقون. وكانت النتيجة عدم وجود فرق معنوي فيما يتعلق بتذوق مادة فنيل ثايوكاربامايد بين المرضى المصابين بالصرع وتحت علاج عقار كاربامازبين والأشخاص الأصحاء


Article
Developing spectrophotometric method for Carbamazepine (antiepileptic drug) determination through preparation and Characterization of Fe(III) Complex With Mixed Ligand Containing Carbamazepine and Salicylaldehyde
طريقة طيفية لتقدير الكاربامازبين ( عقار مضاد للصرع ) من خلال تحضير معقد الحديد مع ليكاند مختلط من الكاربامازبين والساليسالدهايد

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Abstract

Abstract The research includes developing an easy and sensitive analytical spectrophotometric method to determine Carbamazepine (CBZ) ,which consider among antiepileptic and antisezuires drugs. The method was depended on preparation of mixed ligand [dibenzo[b,f]azepine-5[N-(O-hydroxybenzyliden)] amide from CBZ reaction with salicylaldehyde. It was found that the ligand has an ability to form colored complex with ferric ion at ratio (2:1) L: M , that have λ max at 524 nm in aqueous solution at pH 6.5. The optimum conditions for Complexing CBZ with ferric ion including the volume of ferric solution (1.2 ml), time period (10 minutes) and temperature ranges (30-35 o C) were identified. The structural formula of the formed complex was proposed due to the spectroscopic study including UV and IR spectrums. Stability constant of CBZ-Fe complex in aqueous solution was (1.3x109 L2. mol-2), and the complex was stable for 24 hours in the aqueous solution. Calibration curve obeyed the Beer’s law at (1.0 -25) mg.l-1 for CBZ with a correlation coefficient (r = 0.9996). The molar absorptivity coefficient was 2.17 × 103 l. mol-1cm-1. The statistical processing of the results showed that relative standard deviation 1.1%, the average of relative error 1.42%, while method recovery is 100.2 %. The detection limit was 0.25 mg.l-1 and limit of quotation was 0.83 mg.l-1. The method reveals high accuracy and precision. This method is characterized by no need for solvent extraction. The proposed method was applied on samples of drugs and plasma which provided encouraging resultants.

الخلاصة يتضمن البحث تطوير طريقة تحليلية طيفية سهلة وحساسة لتقدير الكاربامازبين CBZ المعروف بالتكريتول الذي يعد من الادوية المضادة للصرع والتشنجات . أعتمدت الطريقة على تحضير ليكاند مختلط (dibenzo[b,f]azepine-5[N-(O-hydroxybenzyliden)] amide) من تفاعل CBZ مع السالسلديهايد والذي تبين ان له قابلية تكوين معقدات ملونة مع ايون الحديد الثلاثي بنسبة 1 : 2 (ليكاند : فلز) باستخدام طريقة النسبة المولية والتغيرات المستمرة . كان الطول الموجي للامتصاص الأعظم للمعقد (524) نانومتر في المحلول المائي وعند دالة حامضية 6.5، تم تحديد الظروف الفضلى لتقديرCBZ مثل حجم محلول أيون الحديديك (1,2 مل) والفترة الزمنية المثلى التي كانت 10 دقائق ودرجة الحرارة التي تراوحت بين 30 و 35 مْ. درس طيف الأشعة تحت الحمراء (IR) للمعقدالناتج وتمت مقارنتها مع طبف الليكاند وCBZ وشخصت المجاميع الوظيفية المشاركة في عملية التناسق مع اقتراح الصيغة التركيبية للمعقد المتكون. تضمن البحث دراسة ثابت استقرار نواتج المعقد في الوسط المائي، حيث وجد ان ثابت الاستقرار كان 1,3× 10 9 لتر2/مول2 ، كما أنّ المعقد مستقر لـ 24 ساعة في الوسط المائي عند الدالة الحامضية المثلى. يطاوع منحني المعايرة قانون بير من 1 الى 25 ملغم/لتر ، وكان معامل الارتباط (r = 0.9996)، والامتصاصية المولارية للمعقد (2,17 ×310) لتر.مول-1.سم-1 . بينت المعالجة الإحصائية للنتائج أنّ معدل قيم الانحراف القياسي النسبي (RSD) 1,1 % ومعدل الخطأ النسبي 1,42 % ، في حين ان معدل نسبة الاستردادية 100,2 % وحد الكشف 0,25 ملغم/لتر ، مما يدل على أن الطريقة تتمتع بالدقة والضبط الجيد . تمتاز الطريقة أنها لاتحتاج إلى عملية الاستخلاص بالمذيب ، وقد تم تطبيق الطريقة المقترحة بنجاح على نماذج من الأدوية وبلازما الدم .


Article
Effects of Carbamazepine on blood pressure, serum glucose concentration, lipid profile and prevalence of metabolic syndrome in epileptic patients

Author: Isam Hamo Mahmood
Journal: Tikret Journal of Pharmaceutical Sciences مجلة تكريت للعلوم الصيدلانية ISSN: 18172716 Year: 2012 Volume: 8 Issue: 2 Pages: 248-255
Publisher: Tikrit University جامعة تكريت

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Abstract

To investigate the effects of carbamazepine on serum glucose concentrations, lipid profile, blood pressure and prevalence of metabolic syndrome in epileptic patients. Seventy epileptic patients involved in this study. They have primary generalized and partial seizures with duration of treatment with carbamazepine of 11.5±8.37 years. Another 100 apparently healthy individuals were also participated in the study as a control group. Ten ml of venous blood samples were taken from each patient and control after 14 hours fasting. The obtained serum was separated and used for the estimation of glucose concentration, total cholesterol, triglycerides and HDL-cholesterol by using special Kits. LDL-cholesterol was determined by Friedewald equation. Metabolic syndrome was determined according to ATP III criteria for the diagnosis of metabolic syndrome. The patients and controls were matched regarding age and sex. Weight, BMI and waist circumference were statistically not different between patients and controls. Comparison between the measured variables shows significant elevations of the lipid parameters in the patient group as compared with the control group. Non significant differences obtained between serum glucose concentrations and significant low values of BP were obtained in the patient group as compared with the controls. The number of patients and control having metabolic syndrome according to ATP II diagnostic criteria for metabolic syndrome were 4 and 3, respectively. The difference is not significant. This study demonstrated that carbamazepine have no effects on serum glucose concentrations, but have elevating effects on lipid parameters and reducing effects on BP. It has no effects on the prevalence of metabolic syndrome in the epileptic patients

Keywords

Epilepsy --- carbamazepine --- glucose --- lipids --- BP --- metabolic syndrome


Article
Spectrophotometric Determination of Mesalazine, Carbamazepine and Diclofenac Sodium in Pharmaceutical Preparations by Using Nile Blue Dye

Authors: Elham S. Salih --- Abdussamed M. A. Saeed
Journal: JOURNAL OF EDUCATION AND SCIENCE مجلة التربية والعلم ISSN: 1812125X Year: 2019 Volume: 28 Issue: 4 Pages: 48-69
Publisher: Mosul University جامعة الموصل

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Abstract

A simple and accurate spectrophotometric method has been suggested for the determination of Mesalazine (MES), carbamazepine (CAM) and diclofenac sodium (DFS) in pure and pharmaceutical dosages. The method is based on the oxidation of drugs in acidic medium with known excess of N-bromosuccinimide (in case of MES), or bromate-bromide mixture (in case of CAM and DCF) and subsequent determination of unreacted oxidant by decolorization of nile blue dye (NB) and measure the absorbance of unoxidized dye at 640 nm. Calibration curves of the dye in the presence of studied drugs were rectilinear over the ranges 0.1-2.2, 0.4-2.4 and 0.6-2.8 µg ml-1 with molar absorptivity of 6.21×104, 1.05×105 and 1.21×105 l.mol-1.cm-1 for MES, CAM and DCF respectively. The common excipients and additives didn’t interfere in their determination. The suggested method was successfully applied for determination of the studied drugs in their pharmaceutical forms resulted in a good agreement with standard British pharmacopeia method and standard addition procedure


Article
Effects of carbamazepine on serum leptin, insulin levels and oxidative stress in epileptic patients

Authors: Mohammed M. Al-Sheikh محمد محمود الشيخ --- Othman A. Pachachi عثمان باجه جي --- Imad A. Thanoon عماد عبد الجبار ذنون
Journal: Annals of the College of Medicine Mosul مجلة طب الموصل ISSN: 00271446 23096217 Year: 2012 Volume: 38 Issue: 1 Pages: 40-45
Publisher: Mosul University جامعة الموصل

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Abstract

Objectives: To assess the effect of carbamazepine (CBZ) monotherapy in male adult epileptic patients on serum leptin, insulin levels, body mass index and oxidative stress represented by serum malondialdehyde (MDA) in comparison to healthy controls.Patients and methods: To achieve the aims of the current study, a case-control study design was adopted. A total of 38 male adult patients with primary generalized epilepsy, on continuous CBZ monotherapy, for at least six months before participation in the study, were collected over the period from Sept. 2010 to Jan. 2011. Forty apparently healthy male volunteers without previous history of epilepsy were recruited as controls. Fasting blood samples were taken and sera were separated and used to measure serum levels of leptin and insulin, and MDA. Body mass index (BMI) was calculated as weight in kilograms divided by the squared height in meters.Results: The results of this study revealed that there was insignificant difference in BMI, serum leptin and insulin between male epileptic adult patients and their matched control subjects. The results also revealed that male epileptic adult patients had a significantly higher (p<0.001) serum MDA compared to their matched control subjects.Conclusion: Carbamazepine is a relatively low risky antiepileptic drug (AED) in terms of obesity, while it can cause oxidative stress as reflected by an elevated serum MDA in comparison to controls.Keywords: Epileptic patients, carbamazepine, BMI, leptin, insulin, malondialdehyde

الأهداف: لتقييم تأثير الكاربامزابين كعلاج أحادي في مرضى الصرع من البالغين الذكور على مستوى اللبتين والأنسولين في مصل الدم وجهد الأكسدة ممثلا بالمالونديليهايد ومؤشر كتلة الجسم بالمقارنة مع مجموعة ضبط.المرضى وطرق العمل: للوصول الى أهداف هذه الدراسة، تم تحديد تصميم معين لهذه الدراسة. شملت الدراسة 38 من الذكور البالغين المصابين بالصرع الابتدائي الشامل على علاج أحادي مستمر بالكاربامزابين لفترة لاتقل عن 6 أشهر. تم انتقاء الحالات وفق ضوابط خاصة للفترة من سبتمبر2010 الى كانون الثاني 2011. شملت الدراسة أيضا 40 من الذكور الأصحاء بلا تاريخ سابق للصرع كمجموعة ضبط. سحبت عينات دم في حالة الصيام صباحا وتم استخدام المصول المستحصلة لقياس مستوىاللبتين والانسولين ومستوى المالونديليهايد. تم حساب مؤشر كتلة الجسم باستخدام معادلة وزن الجسم بالكيلوغرام مقسما على مربع الطول بالأمتار.النتائج: أظهرت النتائج تأثيراً غير معنوي لعقار الكاربامزابين على مؤشر كتلة الجسم ومستوى اللبتين والأنسولين في مصل الدم لمرضى الصرع من الذكور بالمقارنة مع مجموعة الضبط. أظهرت النتائج أيضا ان زيادة معنوية في مستوى المالونديليهايد عند مرضى الصرع من الذكور المثبتين على الكاربامزابين كعلاج أحادي مستمر بالمقارنة مع مجموعة الضبط.الاستنتاج: من الممكن الاستنتاج ان الكاربامزابين كعقار مضاد للصرع هو نوعا ما قليل المخاطر فيما يتعلق بزيادة الوزن وحالة المتلازمة الأيضية ولكن ممكن ان يسبب زيادة في جهد الأكسدة (متمثلاً بزيادة مستوى المالونديليهايد في مصل الدم بالمقارنة مع مجموعة الضبط).مفتاح الدلالة: مرضى الصرع, الكاربامزابين, دلالة كتلة الجسم, اللبتين, الأنسولين, المالونديليهايد.


Article
A Highly Sensitive Kinetic-Spectrophotometric Method for the Assay of Carbamazepine in Pure and Commercial Tablet
طريقة طيفية حركية ذات حساسية عالية لتقدير عقار الكاربامازيبين بصورته النقية وفي المستحضرات الصيدلانية

Authors: Sarmad B. Dikran سرمد بهجت ديكران --- Faeza H. Zankanah وفائزة حازم حسن
Journal: Iraqi Journal of Pharmaceutical Sciences المجلة العراقية للعلوم الصيدلانية ISSN: 16833597 Year: 2017 Volume: 26 Issue: 1 Pages: 1-8
Publisher: Baghdad University جامعة بغداد

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Abstract

The study aimed to recommend a new spectrophotometric-kinetic method for determination of carbamazepine (CABZ) in its pure form and pharmaceutical forms. The proposed procedure based on the coupling of CABZ with diazotized sulfanilic acid in basic medium to yield a colored azo dye. Factors affecting the reaction yield were studied and the conditions were optimized. The colored product was followed spectrophotometrically via monitoring its absorbance at 396 nm. Under the optimized conditions, two method (the initial rate and fixed time (10 minute)) were applied for constructing the calibration graphs. The graphs were linear in concentration ranges 2.0 to 18.0 µg.mL-1 for both methods. The proposed was applied successfully in the determination of CABZ in its commercial formulations.

الخلاصةيهدف البحث الى تطوير طريقة طيفية حركية لتقدير عقار كاربامازيبين بصورته النقية وفي مستحضراته الدوائية. تعتمد هذه الطريقة على ازدواج عقار الكاربامازيبين مع الكاشف حامض سلفانيلك المؤزوت في وسط قاعدي. حيث تم دراسة العوامل التي تؤثر على التفاعل وتثبيت الظروف المثلى، ويصاحب التفاعل الطيفي قياس معدل التغير في الامتصاصية عند طول الموجي 396 نانومتر، وعند الظروف المثلى تم دراسة حركية التفاعل وإيجاد منحني المعايرة من خلال طريقتي معدل السرعة والزمن الثابت عند 10 دقائق، وكانت حدود التراكيز بين 2.0-18.0 مكغم. مل-1. وقد تم تطبيق الطريقة بنجاح لتقدير عقار الكاربامازيبين في مستحضراته الدوائية.


Article
Comparison of dissolution release of commercially available extended release carbamazepine tablets in Iraqi drug market using in vitro USP II method
مقارنة بين إطلاق محلول أقراص الكاربامازيبين الممتدة المتوفرة تجارياً في سوق الأدوية العراقي باستخدام طريقة USP II المختبرية

Authors: Adnan Burhan Qader --- Tara Abdulrahman Abdullah
Journal: Zanco Journal of Medical Sciences مجلة زانكو للعلوم الطبية ISSN: 19955588/19955596 Year: 2016 Volume: 20 Issue: 2 Pages: 1288-1293
Publisher: Hawler Medical Univeristy جامعة هولير الطبية

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Abstract

Background and objective: Carbamazepine is widely used as an anti-epileptic drug, primarily for the treatment of partial and tonic-clonic seizures. The drug is absorbed slowly and variably after oral administration due to its limited water solubility. In clinics, single daily dosing of conventional dosage forms of carbamazepine is insufficient; effective levels are provided by the multiple-dose administration. A multiplicity of dosage causes inconsistent plasma levels leading to side effects because of its narrow therapeutic range and toxicity levels. A single dose of extended release dosage forms is suggested to keep levels within the therapeutic concentrations. This study aimed to compare the in vitro behavior of generic tablets containing carbamazepine with the brand product.Methods: Basket apparatus was used to evaluate in vitro behavior of the different products and similarity test was applied to evaluate the differences between generic products and the brand. The study and test were carried out in Jun 2014 at the College of Pharmacy, Hawler Medical University. Results: There was a significant difference between the in vitro behavior of one of the generic products in the study and the in vitro behavior of the brand product. Conclusions: The in vitro study using basket apparatus could be considered as an effective method to evaluate the in vitro behavior of the majority of pharmaceutical dosage forms. In vitro behavior is a direct indicator for in vivo one. Therefore the quality of the medicaments could be evaluated and the risk to the patients could be significantly reduced.

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