scholarly journals Comparative Study of Different Products of Carbamazepine Tablets Available in Iraqi Market

2021 ◽  
Vol 11 (2-S) ◽  
pp. 50-55
Author(s):  
Mohammed K Al-Shaheen ◽  
Saad M Majeed ◽  
Radhwan Nidal Al-Zidan

Carbamazepine (CBZ) is a widely used antiepileptic drug to control grand mal epilepsy, as well as for the treatment of peripheral neuralgia. According to the biopharmaceutical classification system (BCS), CBZ is considered a class II drug. CBZ is characterized by a slow and irregular gastrointestinal absorption, with irregular oral bioavailability; due to its low water solubility. Therefore, the release of the drug from the dosage form (tablets in this study) and the subsequent step of dissolution represent the most important parameters that decide whether a sufficient plasma concentration will be achieved or not. In the current study, the FTIR study for the pure API, CBZ, and the different commercially available brands of CBZ conventional tablets, available in the Iraqi drug market (Mosul city as an example), were examined. Subsequently, various quality control parameters such as the weight variation, content uniformity, friability, and hardness of the conventional CBZ tablets were conducted. Moreover, the disintegration and the dissolution tests of the different brands of CBZ available in the Iraqi drug market were performed. Keywords: Antiepileptic Drug, Bioequivalence; Epilepsy; Generic; Brand vs generic; IVIVC; QC

Cinnarizine is an anti-histaminic drug and is mainly used to treat symptoms accompanying motion sickness like vomiting and dizziness. It has low and variable bioavailability due to its low water solubility. Cinnarizine (weakly basic drug) is formulated as raft forming chewable Tablets to allow its complete dissolution at the stomach to be absorbed at the upper part of small intestine. Raft forming chewable Tablets are formulated by direct compression method using sodium alginate or pectin as raft forming agents. The prepared Tablets were evaluated for their pre and post- compression parameters and they have shown desirable results regarding evaluation of hardness, thickness, % friability, weight variation, content uniformity, raft strength, weight and volume, in addition to in-vitro drug release. Out of all the prepared formulas F1 selected as the optimum formula with 488.1mg raft strength and 92.34% drug release after 24hrs that is promising for the formulation of the raft system.


Author(s):  
Ganesh kumar Gudas ◽  
Manasa B ◽  
Senthil Kumaran K ◽  
Rajesham V V ◽  
Kiran Kumar S ◽  
...  

Promethazine.HCl is a potent anti-emetic. The central antimuscarinic actions of antihistamines are probably responsible for their anti-emetic effects. Promethazine is also believed to inhibit the medullary chemoreceptor trigger zone, and antagonize apomorphine -induced vomiting. Fast dissolving tablets of Promethazine.HCl were prepared using five superdisintegrants viz; sodium starch glycolate, crospovidone, croscarmellose, L-HPC and pregelatinised starch. The precompression blend was tested for angle of repose, bulk density, tapped density, compressibility index and Hausner’s ratio. The tablets were evaluated for weight variation, hardness, friability, disintegration time (1 min), dissolution rate, content uniformity, and were found to be within standard limit. It was concluded that the fast dissolving tablets with proper hardness, rapidly disintegrating with enhanced dissolution can be made using selected superdisintegrants. Among the different formulations of Promethazine.HCl was prepared and studied and the formulation S2 containing crospovidone, mannitol and microcrystalline cellulose combination was found to be the fast dissolving formulation. In the present study an attempt has been made to prepare fast dissolving tablets of Promethazine.HCl, by using different superdisintegrants with enhanced disintegration and dissolution rate. 


2015 ◽  
Vol 14 (1) ◽  
pp. 61-70 ◽  
Author(s):  
S Vidyadhara ◽  
RLC Sasidhar ◽  
B Deepti ◽  
E Wilwin ◽  
B Sowjanyalakshmi

In the present investigation an attempt has been made to formulate medicated lozenges containing amoxicillin trihydrate. There are several amoxicillin trihydrate dosage forms in the market such as tablet, capsule, suspension and syrup. Still there is a need for more variant dosage forms which acts effectively and locally. The benefits of the present research work is to increase the retention of the dosage form in oral cavity for increased bioavailability, reduction in gastric irritation and bypassing first pass metabolism. The lozenges were prepared by heating and congealing method employing polyethylene glycol 1500 as matrix base, saccharin sodium (artificial sweetener), stevia (natural sweetener), xanthan gum (polymer), sodium carboxymethyl cellulose (polymer) as other exciepients. The prepared medicated lozenges were characterized for drug content uniformity, hardness, thickness, weight variation, friability and dissolution by standard pharmacopeal methods. The results of the evaluation tests obtained were within the limits. Accelerated stability studies were conducted as per ICH guidelines and found that there wasn’t any substantial interaction among the drug, flavour and colour and the prepared formulations were found to be stable. Formulations were tested for drug exciepients interactions subjecting to IR spectral and DSC analyses. The results revealed that there was no major interactions between the drug and polymers used for the preparation of lozenges.Dhaka Univ. J. Pharm. Sci. 14(1): 61-70, 2015 (June)


Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 96 ◽  
Author(s):  
Md. Islam ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Chisana Uwatoko ◽  
Mohammad Rahman ◽  
...  

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.


2017 ◽  
Vol 9 (6) ◽  
pp. 39
Author(s):  
Zainab E. Jassim

Objective: The purpose of this study was to enhance the dissolution pattern of the practically water-insoluble diuretic drug, furosemide through its formulation into liquisolid tablets.Methods: A mathematical model was used to formulate four liquisolid powder systems using polyethylene glycol 400 as a non-volatile water miscible liquid vehicle. The liquid loading factors of the vehicle were used to calculate the optimum quantities of carrier (Avicel PH 102) and coating materials (Aerosil 200) needed to prepare acceptably flowing and compactible powder mixtures and (R) ratio used was 25. The liquisolid tablets were evaluated for weight variation, percent friability, hardness, content uniformity, disintegration time and in vitro drug release profile. Drug and the prepared systems were characterized by fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and powder x-ray diffraction (PXRD) studies.Results: The enhanced dissolution rate due to the increased wetting properties and the large available surface areas for dissolution were obtained in case of the liquisolid tablets. The selected optimal formulation (F2) of 50% drug concentration released 90% of its content during the first 10 min compared to 65% of DCT. FTIR studies revealed that there was no interaction between drug and polymers. DSC and PXRD indicated conversion of crystalline to amorphous form of furosemide. Conclusion: The dissolution rate of furosemide can be enhanced to a great extent by liquisolid technique.


2017 ◽  
Vol 16 (10) ◽  
pp. 2325-2330
Author(s):  
Qiong Jin ◽  
Wei Chen ◽  
Wan Wu

Purpose: To develop mucoadhesive tablets containing miconazole (MCZ) for the treatment of oropharyngeal candidiasis, using chitosan and hydroxypropyl methylcellulose (HPMC) as mucoadhesive polymers.Methods: Mucoadhesive tablets were formulated and optimized using a 23 factorial design and direct compression method. The independent variables were compression force and concentrations of chitosan and HPMC, while mucoadhesion time and in vitro drug release were dependent variables. Tablet characterization was carried out by evaluating hardness, thickness, tablet weight variation, content uniformity, friability and in vitro drug release at salivary pH (pH 6.8).Results: The tablets showed good mucoadhesion for an extended period (8 h), and their physical characteristics were within acceptable ranges. Drug release ranged from 60.5 % to 80.8 %.Conclusion: These results indicate that the mucoadhesive MCZ tablets formulated with chitosan and HPMC possess potential for the development of therapeutic preparations for management of oropharyngeal candidiasis.Keywords: Miconazole, Oropharyngeal candidiasis, Factorial design, Mucoadhesion, Chitosan, Drug release


Author(s):  
PARVEEN KUMAR ◽  
BIRENDRA SHRIVASTAVA ◽  
MADAN MOHAN GUPTA ◽  
ANIL KUMAR SHARMA

Objective: Transdermal patch of timolol maleate was prepared in order to increase the permeability of the drug topically. Methods: The timolol maleate (TM) loaded solid lipid nanoparticles (SLN) were prepared by the solvent evaporation method. For the optimization process full factorial (three-factor and three-level), hydroxypropyl methylcellulose (HPMC) range from 100 to 300 mg, ethylcellulose 100 to 200 gm and almond oil 3 to 4 ml. The response noted in form of tensile strength and percent drug release. These transdermal patches were evaluated for physical characterization like weight variation, thickness, percentage moisture absorption, percentage moisture loss, water vapor transmission rate, folding endurance, tensile strength, and content uniformity. Results: Solid lipid nanoparticles of TM were optimized and prepared, the data presented that drug release percent ranged from 66.12 to 91.75. 2FI model was observed to fit for response % drug permeation with a p and F value of 0.0271 and 4.50. The tensile strength varies from 0.358 to 0.508. The linear model was observed to fit for the tensile strength response with a p-value and F-value of<0.0001 and 52.41. Conclusion: The controlled release formulation of Timolol Maleate was successfully optimized and prepared, a study conducted to investigate the effect of different polymers and type of permeation time profiles from Timolol Maleate patches.


2008 ◽  
Vol 42 (5) ◽  
pp. 613-620 ◽  
Author(s):  
Michael A Veronin ◽  
Nga T Nguyen

Background: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policy-makers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. Objective: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. Methods: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pbarmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. Results: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. Conclusions: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.


2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
V. J. Kapure ◽  
V. V. Pande ◽  
P. K. Deshmukh

In present investigation liquisolid compact technique is investigated as a tool for enhanced dissolution of poorly water-soluble drug Rosuvastatin calcium (RVT). The model drug RVT, a HMG-Co A reductase inhibitor was formulated in form of directly compressed tablets and liquisolid compacts; and studied for in-vitro release characteristics at different dissolution conditions. In this technique, liquid medications of water insoluble drugs in non-volatile liquid vehicles can be converted into acceptably flowing and compressible powders. Formulated systems were assessed for precompression parameters like flow properties of liquisolid system, Fourior transform infra red spectra (FTIR) analysis, X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), and post compression parameters like content uniformity, weight variation, hardness and friability, disintegration test, wetting time, in vitro dissolution studies, effect of dissolution volume on drug release rate, and estimation of fraction of molecularly dispersed drug in liquid medication. As liquisolid compacts demonstrated significantly higher drug release rates, we lead to conclusion that it could be a promising strategy in improving the dissolution of poor water soluble drugs and formulating immediate release solid dosage forms.


2012 ◽  
Vol 1 (5) ◽  
pp. 103-109 ◽  
Author(s):  
Palash Karmakar ◽  
Md Golam Kibria

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109


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