[Study and evaluation the influence of HPMC combination with different polymers in ketoprofen controlled release matrix tablets]

The controlled release of the drug is performed by trying to achieve to zero order kinetic mechanism from the dosage form. Zero-order kinetic mechanism means that drug release is separated from amount of the drug in a delivery system [the rate of released drug is constant during the time]. HPMC is Hydrophilic swellable polymer and widely used to control the release of drugs from matrix formulations, the release of drugs from their matrices depends on percentage of polymer in the matrices and its viscosity. In this study we investigate the applicability of HPMC combination with different polymers [PEG6000, Sodium alginate, Xanthan gum and PVA] for controlling the release of ketoprofen from matrix tablets. In drug release profiles, an initial rapid burst occurs in the first hour for matrices that consist of HPMC, then the release decrease during the time, it is not a suitable for Zero-order kinetic mechanism, but the initial rapid burst did not occur in the first hour for matrices that consist of HPMC combination with different polymers or HPMC polymers with various viscosities. The release during the time differs according to the type of studied polymer and the percentage of the two polymers and viscosity of the interested HPMC within the matrix. The kinetics of ketoprofen release was analyzed using different drug release models [zero order, first order, Higuchi, Korsmeyer and Peppas, Hixon and crowel], Zero order and Korsmeyer and Peppas equations were suitable for most of dissolution data from matrix tablets [0.95< R[2] <0.99]. The value of correlation factor R[2] according to zero order increases in combinations comparison to formulas that consist of HPMC alone

[Comparative study for the analytical performance of potassium clavulanate assay methods in the United States, British, and Japanese pharmacopoeias]

A comparative study was conducted to verify the performance parameters of the compendial methods utilized for the assay of potassium clavulanate in the United States [USP], British [BP], and Japanese [JP] pharmacopoeias. The aim of the study was to find out the degree of accordance between the methods in terms of accuracy, precision, and linearity in the range 50-150% of the sample solution concentration provided in the monograph. The stability-indicating power of each method was verified in order to determine their suitability for use in stability studies in addition to the approximate cost of each method

[Using near infrared [NIR] in homogeneity test for bulk products of vitamins B1, B6 and B12]

Process validation is one of the basic requirements of the current good manufacturing practices cGMPs, and homogeneity test is one of the important tests during In Process Control "IPC". The aim of the research is to investigate the use of near infrared "NIR" in homogeneity test for bulk powders of vitamins of vitamins B1, B6, B12 prepared for granulation as an indicator of process validation, and investigating the performance of this technology in the circumstances of local pharmaceutical industry, and explaining its advantages compared to present used analytical technologies. The research results indicated that NIR technology has succeeded to be an indictor of process validation of mixing bulk powders of vitamins B1, B6 prepared for granulation, so the high performance liquid chromatography HPLC method could be replaced by NIR method for the homogeneity test of bulk powders vitamins B1, B6, while the NIR technology did not succeed as indicator of process validation for the vitamin B12 with 1 or 5 mg concentrations, because the NIR Technology failed to perform quantitative analysis of vitamin B12 1.65% w/w concentration, because the R[2] value was 94.18% and the RMSECV was 4 and that is less than the requirement of the quantitative analysis using NIR. The research assured that the change of the source of the raw material will obligate the development of new method of NIR, this due to the change of crystals forms or the change of concentration [potency] of the active material. The research clarify that NIR technology is fast, environmentally safe, and economic by saving time and money

[Studying the relationship between dissolution and absorption of the oral dosage forms locally manufactured containing macrolides and beta-lactam groups using Schulman cell]

The aim of the present study was to develop a model that can predict gastrointestinal absorption for a diverse range of drugs using the immobilized artificial membrane retention properties and the selected diffusion cell [schulman type]; the proposed method was employed to evaluate the apparent permeability of a set of 12 structurally diverse drugs having different solubility and permeability properties. An excellent linear correlation [R[2]=0.92] was obtained between the developed cell apparent permeability and human absorption data. A comparison of permeation data of some drugs obtained using retention properties of the immobilized artificial membrane [LAM] and the corresponding HIV values in humans further confirmed the proposed permeation method as predictor of the oral absorption of passively absorbed drugs. A comparative study between the permeability data for some solid dosage forms which belong to class III and class IV, and dissolution profile data can explain the effect of the permeability enhancers and formulation on the mechanism of drug absorption

comparative study of legal and illegal items of different commercial brands of mefenamic acid 500 mg tablets as non-steroid anti-inflammatory and analgesic agent

Mefenamic acid, N-[2,3-Xylyl]-2-Aminobenzoic acid or N,2,3-Xylylanthranilic acid is an analgesic, antipyretic and non-steroidal anti-inflammatory drug. The aim of this study is to assess the quality and the quantity of the legal and illegal types of mefenamic acid 500 mg tablets marketed in Yemen. We have selected six legal types of mefenamic acid tablets, which are registered by the Supreme Board of Drugs and Medical Appliances and one illegal type of mefenamic acid which is a smuggling drug without name of brand [Welstan forte 500 mg] [China]. We have applied the qualitative and quantitative analysis for evaluating the items. The limit of content of mefenamic acid tablets is [95-105%] according to B.P. The result of analysis of these seven items of mefenamic acid were evaluated and showed that the qualitative analysis of six items, complied with B.P requirements whereas the uniformity of weight of tablets of smuggled drug [Welstan forte 500 mg] [China] did not. The quantitative analysis showed that the five types of mefenamic acid, [Ponstan forte 500 mg] [Park-Devis, Germany] [97.48%], [Pangesic forte 500 mg] [Ram Pharma, Jordan] [101.34%], [Ponsten forte 500 mg] [Birkl-Dove, Turkey] [103.27%], [Ponstel forte 500 mg] [Shin Poong Pharma, Korea] [98.93%], [Omatan forte 500 mg] [NP, Oman] [104.24%], complied with B.P, whereas the two items [Biostan forte 500 mg] [Biopharm, Yemen][86.86%] and [Welstan forte 500 mg] [China] [84.45%] did not comply

Analytical study of clarithromycin produced by companies which did not possess the patent rights

Many pharmaceuticals companies around the world produce active ingredients in spite of the fact they do not own the patent or marketing rights. These companies market these substances at prices lower than those of the patent holders. We have carried out analytical studies of some of these active ingredients. The aim of these studies is to establish their identity and purity as compared to those produced by the patent holders or to compendial reference standards. We have used analytical techniques such as infra-red spectrum, proton nuclear magnetic resonance [H' NMR], elemental analysis, and liquid chromatography linked with mass spectroscopy in addition to conventional techniques mentioned in compendial monographs like melting point, pH and residue on ignition tests. In the first part of this study, we have analyzed a sample of Clarithromycin manufactured by Indian Company [Ranbaxy], which manufactures several active ingredients still under patent. This sample has shown approximately the same identification as the material produced by Abbott Laboratories Ltd., a company that already holds the patent and marketing rights

Stability-indicating HPLC assay method of lovatatin

An HPLC assay method for determining of lovastatin in the presence of its degradation products was validated under acidic, basic, hydrogen peroxide, high temperature, and photoirradiated conditions. The HPLC system consisted of a Lichrospher 100 RP-18 [5 micro m] column, and a guard column of Lichro CART [150x 3.9] using a mobile phase of acetonitrile-phosphoric acid [0.1%] [50: 50, v/v] with UV detection at 238 nm. The results indicate that the established assay method is suitable for stability measurements of lovastatin. From the stress treatments, lovastatin was determined to be sensitive to the light, acidic, and basic medium

Developing stability-indicating HPLC method for the determination of sodium diclofenac in the presence of its degradation products

A stability indicating reversed-phase liquid chromatographic [HPLC] method was developed for the determination of Sodium Diclofenac in the presence of its degradation products. The chromatography was performed on a C18 column. Eluents were monitored by UV detection at 254 nm using the mobile phase acetonitrile-sodium acetate [pH 5.5; 0.02 M] [70: 30, v/v], using mefenamic acid as internal standard. The method was statistically validated for linearity, accuracy, precision and specificity. The linearity of Sodium Diclofenac peak area responses was demonstrated within the concentration range of 50 to 150 mcg ml. Correlation coefficients were around 0.999. The limits of detection and quantitation were 1 and 2.5 mcg/ml, respectively. The method was demonstrated to be precise, accurate and specific with no interference from the injectable solution excipients and good resolution of the drug peak from the peaks of the degradation products. The retention time for Sodium Diclofenac was 2.08 minutes, and retention times for its degradation products were: 0.97, 1.30, 1.68 and 2.53 minutes. The stability-indicating nature of this method was confirmed by accelerated degradation of Sodium Diclofenac, Solutions of Sodium Diclofenac 10 meg/mI, were stored in 0.1 NHCI, 0.1 NNaOH at room temperature [approximately 25°C] for 2 weeks which produced degradation products, afterwards these solutions were injected in HPLC apparatus, and the peaks of the degradation products did not interfere with Sodium Diclofenac peak The retention time of Sodium Diclofenac was of 2.08 mm, while of its degradation products were 0.97, 1.30, 1.68, 2.53 respectively. The results indicated that the proposed method could be used in a stability assay