Development And Validation Of Stability-Indicating Rp-Uplc Method For The Simultaneous Estimation Of Tezacaftor And Ivacaftor In Formulations

Objective: Aim of the present research work was to develop a sensitive, rapid and accurate, stability-indicating RP-UPLC method for the simultaneous estimation of tezacaftor and ivacaftor in formulations. Methods: The chromatographic separation of the mixture of tezacaftor and ivacaftor was attained in isocratic method utilizing a mobile phase of 0.1 % orthophosphoric acid and acetonitrile in the proportion of 50:50%v/v utilizing a HSS C18 column which has dimensions of 100×2.1 mm, 1.7 m particle size and the flow rate of 0.3 ml/min. The detection system was monitored at 292 nm wavelength maximum with 1.5 ml injection volume. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity and precision. Results: The retaining time for tezacaftor and ivacaftor were achieved at 1.071 min and 0.530 min, respectively. Tezacaftor, ivacaftor and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The developed method was highly sensitive, rapid, precise and accurate than the earlier reported methods. The total run time was decreased to 2.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of tezacaftor and ivacaftor. Conclusion: The projected method can be utilized for routine analysis in the quality control department in pharmaceutical trades.

Formulation and stability studies of metformin hydrochloride in a controlled porosity osmotic pump system

This study was designed to formulate, for the first time, metformin hydrochloride (MH, 850 mg/tablet) as a controlledporosity osmotic pump (CPOP) system to achieve zero-order release pattern. MH core tablet was coated with celluloseacetate membrane containing PEG 400. The effect of different percentages and molecular weights of polyethyleneoxide (PEO, 900K and 4M) in tablet core was studied. The United States Pharmacopeia (USP) apparatus II andphosphate buffer pH 6.8 were used for the release studies; meanwhile, a promising formula was tested in biorelevantmedia. The stability of some selected formulations was carried out for 6 months, at bench and accelerated conditions.Evaluation included: MH content, Differential scanning calorimetry (DSC), Scanning electron microscopy (SEM),drug release, and kinetics. Results revealed that increasing PEO percentage within the core decreased MH release.SEM verified formation of pores in the membrane that accounts for MH release. Almost all stored tablets werestable for all studied parameters. MH endothermic peak maintained its position and energy of enthalpy on storageas confirmed by DSC. MH release rate from a promising formula, following zero-order release model, increased by28% in biorelevant media compared to phosphate buffer. Subsequently, in vitro release in biorelevant media could beemployed as a tool to anticipate in vivo tone of CPOP formulations

Stability indicating RP-HPLC method for simultaneous determination of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation: Application to method validation

The present work takes into account the development of Reverse Phase High Performance Liquid Chromatography(HPLC) for simultaneous method estimation and validation of pyrimethamine and sulfamethoxypyrazine inpharmaceutical formulation. The chromatographic separation was accomplished on C8 column by using acetonitrileand potassium dihydrogen phosphate as the mobile phase (60:40 v/v) having a flow rate of 0.8 ml/minute. Theeluent was detected at 254 nm, simultaneously for both the drugs. The retention time for pyrimethamine andsulfamethoxypyrazine was found to be 3.33 and 4.21 minutes, respectively. According to the International Conferenceon Harmonisation guidelines, the develop method was validated in terms of accuracy, precision, linearity, limit ofdetection, limit of quantitation, robustness, and stress degradation studies. This validated method can be suggested forthe routine simultaneous laboratory analysis of pyrimethamine and sulfamethoxypyrazine.

Development of validated stability indicating RP-HPLC method for the estimation of glecaprevir and pibrentasvir in bulk and pharmaceutical dosage form

A novel, selective, precise, and sensitive stability indicating Reverse Phase-High Performance Liquid Chromatography(RP-HPLC) method has been developed and validated for simultaneous estimation of Glecaprevir (GLE) andPibrentasvir (PIB) for bulk and pharmaceutical dosage form. The chromatographic separation was accomplished ona Denali C18 column (150 mm × 4.6 mm, 5 µm) by using mobile phase buffer (pH 4.8) and acetonitrile in the ratio of60:40 v/v. An injection volume of 10 µl was used via manual rheodyne and the solute was detected at a UV wavelengthof 260 nm. The mobile phase was pumped at an ambient temperature of 30°C with a flow rate of 1 ml/minute. Theretention time of GLE and PIB were found to be 2.13 and 3.46 minutes, respectively. The Q2b validation of theproposed analytical method revealed several features; linear regression analysis data showed good linearity over theconcentration range 25–150 µg/ml for GLE and 10–60 µg/ml for PIB with r2 of 0.999 in both the cases and the meanrecovery of them were found to be 100.33% and 100.47%, respectively. The accuracy and precision aspects expressed<2% relative standard deviation value along with adequate robustness. The acid, alkali, neutral, dry heat, UV, andphoto-degradation studies demonstrated the formation of various degradation products. The proposed analyticalmethod proved to be suitable for the routine simultaneous analysis of both the drugs in bulk and tablet formulations.potential, morphology, encapsulation efficiency, and stability of microcapsules. The characterization results from eachformulation reported that the ratio of mangosteen peel extract and maltodextrin at level 50%:50% (MP3) producedmore proportional characteristics than other treatments. The formulation of mangosteen peel extract with maltodextrinat a balanced ratio could be used as an alternative supply and processing of functional food.

A Validated Stability Indicating Rp-Hplc Method Development For Anti Cancer Drug Enzalutamide In Bulk And Pharmaceuticals

A reproducible stability-indicating Reverse Phase-HPLC technique for the quantification of enzalutamide in in pharmaceuticals was developed and validated. Chromatography was achieved on Inertsil-ODS-C18 (250mm×4.6 mm) 5µmanalytical column with acetonitrile: methanol: water in 40:30:30% v/v proportion as mobile phase and flow rate of 1 ml/min. Enzalutamide was detected at 237 nm UV-wavelength maximum. In the present work mobile phase used as a diluent. Developed technique was validated over 20-150 µg/ml linear concentration range for enzalutamide. This method established with linearity coefficient value of 0.99 and the percentage recovery was found to be 99.3%. This method was proven with LOD and LOQ values of 0.53 µg/mL and 1.61µg/ml respectively. The drug was degraded in acid and alkaline conditions and the percentage degradation values were 3.10 % and 4.54 % respectively. There was no degradation of drug when exposed to neutral, UV, thermal, sun-light and oxidative conditions.Drug was undergoing degradation when exposed to acid and alkaline conditions. The developed technique was useful in the routine quantitation of enzalutamide.

Vegetable moisturizing raw material from "Caatinga" Brazilian biome: safety and efficacy evaluations of O/W cosmetic emulsions containing Kalanchoe brasiliensis extract

The purpose of this study was to evaluate the safety of Kalanchoe brasiliensis extract, followed by the development of an oil in water emulsion containing the K. brasiliensis leaves extract and evaluating its clinical moisturizing efficacy. The formulations containing sodium acrylates/ Beheneth-25 methacrylate Crosspolymer (and) hydrogenated polydecene (and) lauryl glucoside and 0.5% of extract were prepared. The extract was considered as non-irritating through skin irritant tests. The stability testing was carried out in different conditions for 90 days. The skin hydration was measured by capacitance measurement and transepidermal water loss using biophysical techniques. The results indicate that the formulation containing 0.5% of extract increased the hydration of the stratum corneum up to 5 h after application on the forearm. The transepidermal water loss was reduced when compared to the untreated area and placebo area. Therefore, we can conclude that the increased skin hydration and protection of barrier function can be attributed to the K. brasiliensis extract. This research presents a new raw material from the Brazilian Caatinga biome and shows its possible application in the development of cosmetic products.

Development and validation of a stability indicating method for quantification of the sesquiterpene lactone eremantholide C from Lychnophora trichocarpha (Brazilian arnica)

ABSTRACT Pharmacological activities as anti-inflammatory, anti-hyperuricemic, anti-gouty arthritis, antitumor and trypanocidal activities of the aerial parts from Lychnophora trichocarpha (Spreng.) Spreng. ex Sch.Bip., Asteraceae (Brazilian arnica) have already been proved. Eremantholide C is a sesquiterpene lactone and one of the active chemical constituents responsible for these activities presented by L. trichocarpha. Therefore, the aim of this work was to develop and validate a stability indicating HPLC method for eremantholide C. Eremantholide C stability was evaluated in L. trichocarpha ethanolic extract and in its isolated form. Analytical conditions employed C18 column, acetonitrile/water in gradient elution, flow of 0.8 ml/min at 30 ºC. To correct for the loss of analyte during sample preparation the use of coumarin as an internal standard was necessary. The developed method provides good separation and resolution of the peaks, allowing quantification of eremantholide C, isolated or directly in the ethanolic extract, in internal standard presence. Validation results showed that this method is linear in the concentration range 2-180 µg/ml, precise, accurate and specific. Stability studies showed that L. trichocarpha ethanolic extract and eremantholide C remain stable for 6 months when stored at room temperature and impermeable glass bottle, therefore they can be used safely and effectively within this period. While at 40 ºC there was stability loss, at 8 ºC a stability increase was observed for the extract and the isolated eremantholide C. Forced degradation studies showed that eremantholide C degraded under acidic and alkaline conditions and was stable for three days under neutral and oxidative conditions, and when exposed to high temperature. Thus, with the development of a stability indicative method and the application of it in eremantholide C stability studies, the results can guide the development of new products that adequately preserve the original features of the biologically active substance with quality, safety and efficacy.

Evaluación de la estabilidad del sistema de diagnóstico inmunoenzimático DAVIH VIH-2 / Evaluation of the stability of the immunoenzymatic diagnostic system DAVIH VIH-2

Introducción: el estudio de la estabilidad de los componentes y el producto terminado constituye un importante requisito regulatorio en los diagnosticadores. Objetivo: realizar un estudio de estabilidad en tiempo real durante doce meses del sistema inmunoenzimático (ELISA) DAVIH VIH-2. Métodos: se realizó un estudio de estabilidad en tiempo real durante doce meses en tres lotes del diagnosticador DAVIH VIH-2, ELISA indirecto diseñado para la detección de anticuerpos contra el virus de inmunodeficiencia humana tipo 2 en suero o plasma humano. Se controlaron los requisitos de calidad de los componentes de acuerdo a sus especificaciones. Se estudió la normalidad de valores de densidad óptica/valor límite y la homogeneidad de las medias y varianzas mediante las dócimas de Grubbs y Cochran. Se estimó la precisión en los controles positivo y negativo del sistema y en seis muestras con diferente reactividad al virus de inmunodeficiencia humana tipo 2 mediante el cálculo del coeficiente de variación y se confeccionaron las cartas de control de los valores de las medias de densidad óptica respecto al tiempo. Resultados: los requisitos de calidad de cada componente se cumplieron durante 12 meses, excepto las características funcionales del conjugado a partir de los seis meses. Los valores en las dócimas de Grubbs y Cochran fueron menores que los valores críticos tabulados para α del 1 y 5 por ciento por lo que existió homogeneidad en las medias y las varianzas en todo el periodo. El coeficiente de variación se mantuvo inferior al 10 por ciento excepto en las muestras con reactividad media y baja, mientras que en las cartas de control, los valores de densidad óptica se mantuvieron en el límite de la media ±2 desviaciones estándar hasta el noveno mes(AU)

Fabrication, Physicochemical Characterization and Evaluation of In vitro Anticancer Efficacy of a Novel pH Sensitive Polymeric Nanoparticles for Efficient Delivery of Hydrophobic Drug against Colon Cancer.

Objective: The present investigation was aimed to overcome the limitations and to enhance the incorporation of the hydrophobic drug into polymeric nanoparticles and characterize the prepared nanoparticles and also to evaluate the in vitro anticancer efficacy of prepared nanoparticles. Method: Nanoprecipitation method was used to prepare plain and hydrophobic drug (Camptothecin) loaded polymeric nanoparticles. Prepared nanoformulations were evaluated for average particle size, particle size uniformity, surface area, zeta potential, surface morphology, drug content, encapsulation efficiency, drug loading, in vitro release, anticancer activity and stability studies at long term and accelerated storage conditions. Results: Plain and Camptothecin loaded polymeric nanoparticles were successfully prepared by nanoprecipitation method using stirring technique. Prepared Camptothecin encapsulated polymeric nanoparticles were (a) spherical in shape with size < 100 nm, displayed excellent uniformity with <0.3 and zeta potential > 20 mV; (b) showed > 95% release in colonic environment; (c) demonstrated enhanced anticancer activity than pure Camptothecin; and (d) extremely stable at both long term and accelerated storage conditions. Conclusion: In summary, the investigation concluded that the prepared Camptothecin encapsulated polymeric nanoformulations may be considered as an attractive and promising formulation which significantly overcome the limitations of Camptothecin and synergistically enhance its anticancer activity.

Formulation and Characterization of Ketoprofen Emulgels.

The present study was intended to formulate the ketoprofen emulgels using different viscosity grades of hydroxypropyl methylcellulose and carbopol as gelling agents. All the prepared emulgels were shown acceptable physical properties concerning colour, homogeneity, consistency, and pH value. Emulgels containing hydroxypropyl methylcellulose were poor in clarity when compared to carbopol formulations. The influence of the type of gelling agent on the drug release from the prepared emulgels was investigated and carbopol 934 showed good results not only in the drug release but also in physical evaluation parameters. From the drug release studies, F3 formulation showed 98.46±2.05% drug release in 8 h with good clarity and physical appearance. The T10% and T80% values of best formulation F3 was found to be 0.9 h and 6.6 h respectively. The T10% and T80% was higher for formulations with carbopol in low concentration when compared to hydroxypropyl methylcellulose K 4M and K 15M in high concentrations, indicating better controlled release. FTIR studies proved the compatibility between drug and carbopol. From the stability studies, similarity index value between dissolution profiles of F3 formulation before and after storage was found to be 87.16. Hence the development of ketoprofen emulgels is a suitable way for topical administration.

Antibacterial, antitussive, antioxidant and toxicological evaluation of Joshanda lozenges.

Joshanda, a Greco-urban formulation comprising seven herbs has been used since centuries for the treatment of cold, cough and associated allergic reactions. Conventionally, it is used in the form of an extemporaneously prepared decoction. However, in the current scenario, lozenges happen to be the dosage form of choice for antitussive drugs. In case of polyherbal drugs, the dosage form assumes a great importance in order to ensure that all the phyto-components exert their pharmacological effect to the maximum. Based on the popularity of lozenges, conventional decoction form of Joshanda was formulated in the form of lozenges. Lozenges were evaluated for routine quality control tests. The most remarkable feature of the formulation was that excellent compression, hardness, friability and disintegration properties could be achieved without the addition of any external binder. The prepared formulation was subjected to in vitro antioxidant activity, antibacterial activity against common respiratory tract pathogens, in vivo antitussive activity and acute toxicity studies using Albino Wistar mice. Accelerated stability studies were conducted as per ICH guidelines. The performance of lozenges was found to be satisfactory in all the tested aspects. Our study proposes the use of lozenges as a preferred dosage form of the conventionally used decoction of Joshanda.

Design and Development of Self-preserving and Preservative-free Herbal Liquid Oral Formulation.

Microbial contamination is one of the major inevitable concerns associated with herbal liquid formulations, which may originate from herbal raw materials. Inclusion of preservatives in herbal liquid formulations has been of considerable value for many years. Anti-microbial preservatives are normally added to prevent microbial proliferation while the product on shelf and during in use conditions. The properties of these preservatives are due to certain functional groups, which are usually harmful to living cells and might therefore be associated with certain risks when used in humans and they are the leading causes of adverse reactions and have negative and potentially life threatening side effects, because they not only act on microorganism but may also interfere with human cells. In this study, we have made an effort to develop a preservative-free and self-preserving liquid oral formulation by understanding and applying alternative principles of preservation (approaches other than using preservatives) by taking Ashoka herb extract as a prototype. Our series of formulation trials using different vehicle systems, which reduce the water activity by controlling the pH and osmotic conditions successfully yielded a vehicle system that could be used for the manufacturing of stable preservative-free/self-preserving herbal liquid oral formulations. Ashoka formulations were found to be physically, chemically and microbiologically stable during the six months of accelerated stability studies.

Stability of Tilo ® tablets formulation obtained from dry extract of Justice pectoralis Jacq

Justicia pectoralis Jacq., Acanthaceae, is a herb known popularly in Cuba as Tilo and used traditionally as sedative. The development in a solid pharmaceutical (Tablets 100 mg) using dry extract of Justicia pectolaris aqueous extract is of interest for the development of phytomedicines, which uses this active raw material. The aim of the present study was to carry out chemical and biological stability studies to the formulation. A method of coumarin determination by High Performance Liquid Chromatography (HPLC) was used and validated. The stability studies during different periods of time (24 months) showed a stability of the product stored at 32 ± 2 °C, and protected of the light.

Justicia pectoralis Jacq., Acanthaceae é uma erva conhecida popularmente em Cuba como Tilo e utilizada tradicionalmente como sedativo. O desenvolvimento de formas farmacêuticas sólidas (comprimido 100 mg) usando extrato aquoso seco de J. pectoralis é de interesse no desenvolvimento de fitoterápicos que empreguem esse princípio ativo. O objetivo do presente estudo foi realizar estudos de estabilidade químicos e biológicos da formulação. Um método de determinação de cumarinas por Cromatografia Líquida de Alta Eficiência (CLAE) foi usado e devidamente validado. Os estudos de estabilidade durante diferentes períodos de tempo (24 meses) mostraram a estabilidade do produto preservado a 32 ± 2 °C e protegido da luz.

Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation.

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm ( max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation studies. The standard calibration curve was plotted for the drug and results showed that the drug was linear (r2 = 0.999) in the concentration range between 0.01 – 1.5 μg/ml. The results of stress testing undertaken according to the International Conference on Harmonization (ICH) guidelines reveal that the selected method is selective and stability-indicating for determination of levitiracetam in pharmaceutical formualtion.

Simultaneous RP-HPLC determination of sparfloxacin and dexamethasone in pharmaceutical formulations

The present study describes the development and subsequent validation of simple and accurate stability indicating RP-HPLC method for the determination of sparfloxacin and dexamethasone in pharmaceutical formulations in the presence of their stress-induced degradation products. Both the drugs and their stress-induced degradation products were separated within 10 minutes using C8 column and mixture of methanol and 0.02 M phosphate buffer pH 3.0 (60:40 v/v, respectively) as mobile phase at 270 nm using diode array detector. Regression analysis showed linearity in the range of 15-105 µg/mL for sparfloxacin and 5-35 µg/mL for dexamethasone. All the analytes were adequately resolved with acceptable tailing. Peak purity of the two drugs was also greater than 0.9999, showing no co-elution peaks. The developed method was applied for simultaneous determination of sparfloxacin and dexamethasone in pharmaceutical formulations for stability studies.

O presente estudo descreve o desenvolvimento e a subsequente validação de indicador de estabilidade simples e acurada por RP-HPLC para a determinação de esparfloxacino e dexametasona em formulações farmacêuticas na presença de produtos de degradação induzidos por estresse. Tanto os fármacos quanto os produtos de degradação induzidos pelo estresse foram separados em 10 minutos, utilizando coluna C8 e mistura de methanol e tampão fosfato 0,02 M, pH 3,0 (60:40 v/v, respectivamente) como fase móvel e detector de arranjo de diodo a 270 nm, A análise de regressão mostrou linearidade na faixa de 15-105 µg/mL para esparfloxacino e 5-35 µg/mL para a dexametsona. Todos os analitos foram resolvidos adequadamente com tailing aceitável. O pico de pureza dos dois foi maior que 0.9999, não mostrando picos de co-eluição. O método desenvolvido foi aplicado para a determinação simultânea de esparfloxacino e dexametasona em formulações farmacêuticas e para estudos de estabilidade.

Design and evaluation of rectal drug delivery systems of non-steroidal anti-inflammatory drug.

The aim of the present study was to design and evaluate the suppositories of aceclofenac a non-steroidal anti inflammatory drug (NSAID). Aceclofenac, rectal suppositories were developed by employing various hydrophilic and hydrophobic polymeric bases like gelatin, PEG-400 and hydrogenated vegetable oil using propylene glycol as plasticizer and beeswax as hardening agent. The in-vitro release rate data was evaluated statistically and was found that from all the formulations the drug release is by diffusion mechanism (r = 0.9547 to 0.9967) according to Higuchi’s equation. All the prepared formulations have shown zero-order release kinetics except those prepared by utilizing 15% and 20 % of PEG-400. The formulation prepared using 7.5% beeswax in hydrogenated vegetable oil has dis-played zero-order drug release (r = 0.9927) and has released 99.18% of the aceclofenac within 4h, hence, this formulation is considered as a promising formulation. The stability study on the promising formulation was con-ducted over a period of 6 months and found that there are no significant changes in the drug content and in-vitro drug release rate (p<0.05). The result suggests that the suppositories can be prepared by employing hydrophilic and hydrophobic polymers.

Estabilidad físico-química y microbiológica de la corteza fresca de Mangifera indica L / The physical, chemical and microbiological stability of Mangifera indica L. fresh bark

Introducción: el extracto acuoso seco que se obtiene a partir de la decocción de la corteza de algunas variedades de Mangifera indica L. es el principio activo de las formulaciones del Vimang®. Este producto de origen natural posee actividad antioxidante, antiinflamatoria, antimicrobiana, espasmolítica, analgésica y antipirética; su componente principal es mangiferina una xantona con varias actividades biológicas reportadas, por lo cual se seleccionó como marcador químico para llevar a cabo los estudios de estabilidad de la corteza y el control de calidad de las formulaciones desarrolladas del extracto de la corteza del árbol del mango, el cual se utiliza en Cuba como suplemento nutricional antioxidante para el tratamiento de diversas enfermedades crónicas. Objetivo: estudiar la influencia sobre las propiedades físico-químicas, microbiológicas y el contenido de mangiferina en la materia prima vegetal, de las condiciones de almacenamiento propuestas para la corteza de Mangifera indica L.Métodos: la corteza se trituró y envasó en bolsas de polietileno y fue almacenada durante 70 d con 2 condiciones de almacenamiento a temperatura 22 ± 1 °C y humedad relativa 55 ± 5por ciento. A la corteza se le determinó la presencia y el conteo total de microorganismos. A los extractos acuosos preparados con la corteza el pH, contenido de sólidos totales y mangiferina; este último por cromatografía líquida de alta resolución. Resultados: en la corteza se observó un rápido crecimiento microbiano y la presencia de microorganismos indeseables desde el inicio mismo del estudio. A los 31 d de almacenamiento en condiciones de temperatura y humedad se observó la aparición de Pseudomonas aeruginosa, un microorganismo patógeno. El contenido de sólidos totales y mangiferina en los extractos no varió significativamente durante el estudio, lo cual indica la ausencia de degradación química de los componentes de la corteza...

Introduction: the dry aqueous extract from the decoction of the bark of some selected Mangifera indica L. varieties is the active principle of some Vimang® formulations. This natural extract was reported to have antioxidant, anti-inflammatory, antimicrobial, spasmolytic, analgesic and antipyretic properties. The main component is mangiferin, a xanthone c-glycosilated, with several reported biological actions. For this reason, mangiferin was chosen as chemical marker for the study of the chemical stability, and the quality control of the different formulations of mango tree bark, commercially used as antioxidant nutritional supplement to treat several chronic diseases. Objective: to study the influence of the suggested storage conditions for Mangifera indica L. bark on the physical, chemical and microbiological properties and the content of mangiferina in the vegeral raw material. Methods: the fresh bark material of Mangifera indica L was grounded and stored in polyethylene bags during 70 days under two storage conditions at 22 ± 1°C and 55 ± 5 percent relative humidity. Presence and total counting of micro-organisms was determined in the bark, whereas the pH value and the content of total solids and mangiferin were identified in the aqueous extract. The mangiferin was analyzed by high performance liquid chromatography. Results: there were observed rapid microbial growth and presence of unwanted micro-organisms from the beginning of the study. After 31 day-storage under specified temperature and humidity conditions, a pathogenic micro-organism called Pseudomonas aeruginosa emerged. The content of total solids and mangiferin in the aqueous extract did not significantly change during the study, which indicated the lack of chemical degradation in these components. The pH value of the aqueous extract decreased as a result of the emergence of fungi in the bark...

Studies on directly compressed ondansetron hydrochloride mucoadhesive buccal tablets using gelatin, chitosan and xanthan gum along with HPMC K4M.

Mucoadhesive buccal tablets containing ondansetron hydrochloride (ODH) were prepared using polymers like gelatin, chitosan, xanthan gum in varying concentration of 5, 10, 15% w/w and HPMC K4M 40% w/w by direct compression technique. Precompressional studies revealed good micromeritic properties of powder blend for compression and were found as per literature limits. The prepared tablets were evaluated for thickness, hardness, uniformity of weight, drug content, friability, swelling index, mucoadhesion strength, in vitro disintegration, dissolution time and permeation studies. The formulations containing xanthan gum gave better mucoadhesion, release characteristics compared to those containing gelatin and chitosan and the rank order of mucoadhesion and permeation across sheep buccal mucosa was xanthan gum > chitosan> gelatin. The tablets apart from fulfilling all the official specifications, exhibited higher rate of release, in vitro release from all ODH buccal tablets followed Super case II transport due to polymer chain disentanglement and relaxation. and found to be stable upon conducting stability studies as per ICH guidelines at 40ºC/75 % RH. The results revealed that mucoadhesive buccal tablets containing ODH were successfully formulated by direct compression technique as an alternative to conventional tablets for therapy of nausea condition in patients.

Stability Testing of Pharmaceutical Products.

Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review.