RESUMO
OBJECTIVE: To evaluate the efficacy of mustard gel versus chlorhexidine (CHX) gel in treating the most resistant Enterococcus faecalis (E. faecalis) bacteria as intra-canal medications. STUDY DESIGN: Randomised controlled trial (in vitro study). Place and Duration of the Study: Department of Operative Dentistry, de'Montmorency College of Dentistry, in collaboration with Lahore General Hospital, between March and October 2021. METHODOLOGY: Forty single-rooted teeth, extracted and randomly allocated, were divided into two groups. Group 1 underwent treatment with CHX gel, while Group 2 was treated with Mustard gel. Subsequently, after disinfection, each tooth was horizontally divided into three equal parts. The middle section was standardised and inoculated with a controlled strain of E. faecalis. Intra-canal medicaments were administered for seven days. Bacterial colonies were quantified as colony forming units (CFU/mL) and subjected to analysis using Statistical Package for Social Sciences (SPSS) version 25. RESULTS: The median bacterial count observed was 1,550 (range 775 - 2,500) for Group 1, contrasting with 400 (range 200 - 775) for Group 2, indicating a significant difference in bacterial count between the groups (p <0.001). CONCLUSION: Mustard gel demonstrated significantly superior efficacy compared to chlorhexidine gel against E. faecalis in root canal procedures. KEY WORDS: Chlorhexidine, Enterococcus faecalis, Mustard, Root canal medicament, Antimicrobial drug-resistance, Root canal irrigants.
Assuntos
Clorexidina , Enterococcus faecalis , Géis , Clorexidina/farmacologia , Humanos , Enterococcus faecalis/efeitos dos fármacos , Irrigantes do Canal Radicular/farmacologia , Anti-Infecciosos Locais/farmacologia , Anti-Infecciosos Locais/administração & dosagem , Cavidade Pulpar/microbiologiaRESUMO
BACKGROUND: Endodontic literature search revealed that no study has been conducted to evaluate the prevalence of apical periodontitis (AP) in root canal treated teeth from an adult Nepalese population of Madhesh Province. Consequently, little is known about the extent and risk factors associated with it. This study aimed to determine AP prevalence in root canal treated teeth from an adult Nepalese subpopulation and to analyze the related risk factors including age, sex, tooth type, type of coronal restoration and quality of root canal treatment and coronal restoration as predictors of AP. METHODS: Digital panoramic radiographs were evaluated. Periapical status of 300 root canal-treated teeth was scored by using the periapical index. The quality of root canal treatment and coronal restorations were categorized as adequate or inadequate through radiographic and clinical evaluation. The data were analyzed using univariate and multivariate logistic regression models. RESULTS: Prevalence of AP in the present study was 31.7%. In 45.7% of the treated teeth, quality of root canal treatment was adequate whereas 46% of the cases had adequate coronal restorations. Multivariate logistic regression analysis revealed statistically significant associations and remarkably increased risk for AP in teeth with inadequate root canal treatment (odds ratio [OR] = 7.92; 95% CI: 3.96-15.82; p < 0.001) whereas lower risk for AP was found in females (OR = 0.51; 95% CI: 0.28-0.90; p = 0.021) and in teeth restored with crown (OR = 0.22; 95% CI: 0.09-0.51; p < 0.001) and filling (OR = 0.18; 95% CI: 0.08-0.42; p < 0.001). Quality of coronal restoration, tooth type and age of the patient were not found to be the predictors of AP. CONCLUSIONS: Within the limits of this study, a high prevalence of AP and poor overall quality of root canal treatment and coronal restoration was found in the subpopulation studied. Quality of root canal treatment, type of coronal restoration and sex of the patient are significant predictors of possible AP development in root canal treated teeth. Substantial efforts are needed to improve the endodontic treatment standards.
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Periodontite Periapical , Dente não Vital , Adulto , Feminino , Humanos , Estudos Transversais , Cavidade Pulpar , Nepal/epidemiologia , Restauração Dentária Permanente/efeitos adversos , Tratamento do Canal Radicular/efeitos adversos , Periodontite Periapical/epidemiologia , Prevalência , Obturação do Canal Radicular , Dente não Vital/epidemiologiaRESUMO
OBJECTIVE: To use Allium sativum oil as non-vital pulpotomy medicament in primary teeth by evaluating its antibacterial effect (Colony-Forming Units/ml- CFU/ml), against Streptococcus mutans and Lactobacillus acidophilus. STUDY DESIGN: A double-blinded, randomised controlled trial. Place and Duration of the Study: Paediatric Dentistry Department, de' Montmorency College of Dentistry, Lahore in collaboration with the Microbiology Department, Lahore General Hospital, from October 2022 to February 2023. METHODOLOGY: Forty patients aged between 4 to 8 years, each containing at least one non-vital primary molar, were randomly divided into Group A (Formocresol) and Group B (Allium sativum oil) using the lottery method. Non-vital pulpotomy (NVP) was performed by removing the coronal necrotic pulp. Sterile paper points were dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments were placed over the root canal orifices and filled temporarily. Patients were recalled after one week. Samples were again taken, and the tooth was restored. Comparison was made between bacterial count at baseline and after one week of treatment, and it was expressed as CFU/ml. RESULTS: There was a significant reduction in median Streptococcus mutans and Lactobacillus acidophilus bacterial count in each group after one week of treatment (p <0.001). Formocresol showed a higher average reduction (30300 ± 14060) compared to Allium sativum oil (24850 ± 9121). However, statistically, the difference was insignificant (p = 0.314) indicating both the medicaments possessed comparable antibacterial effects. CONCLUSION: Allium sativum oil was found an effective alternative to Formocresol. KEY WORDS: Formocresol, Allium sativum, Non-vital pulpotomy, Primary teeth, Randomised controlled trial.
Assuntos
Compostos Alílicos , Formocresóis , Alho , Sulfetos , Criança , Humanos , Pré-Escolar , Pulpotomia/métodos , Dente Decíduo , Antibacterianos/farmacologia , Antibacterianos/uso terapêuticoRESUMO
Introduction: A SeDeM expert tool-driven I-optimal mixture design has been used to develop a directly compressible multiparticulate based extended release minitablets for gastro-retentive drug delivery systems using loxoprofen sodium as a model drug. Methods: Powder blends were subjected to stress drug-excipient compatibility studies using FTIR, thermogravimetric analysis, and DSC. SeDeM diagram expert tool was utilized to assess the suitability of the drug and excipients for direct compression. The formulations were designed using an I-optimal mixture design with proportions of methocel K100M, ethocel 10P and NaHCO3 as variables. Powder was compressed into minitablets and encapsulated. After physicochemical evaluation lag-time, floating time, and drug release were studied. Heckel analysis for yield pressure and accelerated stability studies were performed as per ICH guidelines. The in silico PBPK Advanced Compartmental and Transit model of GastroPlus™ was used for predicting in vivo pharmacokinetic parameters. Results: Drug release follows first-order kinetics with fickian diffusion as the main mechanism for most of the formulations; however, a few formulations followed anomalous transport as the mechanism of drug release. The in-silico-based pharmacokinetic revealed relative bioavailability of 97.0%. Discussion: SeDeM expert system effectively used in QbD based development of encapsulated multiparticulates for once daily administration of loxoprofen sodium having predictable in-vivo bioavailability.
RESUMO
Wheat (Triticum aestivum L) is among the most important cereal crops widely cultivated in the world. Wild oat (Avena fatua L.) competes with wheat for moisture, sunlight, space and nutrition. The successful management of weeds requires sound knowledge of their biology and response to different herbicides. This study inferred the impact of different constant temperature regimes and seed burial depths on seedling emergence and biomass production of wild oat. Moreover, the impact of different post-emergence herbicides applied at different growth stages on biomass production of wild oat was tested. The influence of different wild oat-wheat density (WWD) combinations on biomass production of wheat and wild oat was also inferred. Different constant temperature regimes significantly altered seed germination and biomass production of wild oat. The highest seed germination percentage and biomass production were noted under 15°C and 20°C, whereas the lowest values were recorded under 30°C. Similarly, days to start emergence, seedling emergence percentage and biomass production of wild oat was significantly affected by different seed burial depths. The lowest and the highest values of these parameters were observed under 4 and 10 cm depth, respectively. Different post-emergence herbicides and wild oat growth stages significantly altered biomass production. The highest reduction in fresh and dry biomass was recorded with herbicides' application at 2-4 leaf stage compared with anthesis stage. Clodinofop resulted in higher reduction of fresh biomass, whereas higher reduction in dry biomass was noted with Sulfosulfuron. Seed germination of both species was not affected by different WWD combinations, except for the treatment where no seed was sown of both species. These results indicate that deep burial of seeds could prevent seedling emergence, whereas post-emergence herbicides must be applied at 2-4 leaf stage of wild oat for its effective management.
Assuntos
Avena/efeitos dos fármacos , Avena/crescimento & desenvolvimento , Herbicidas/administração & dosagem , Plântula/efeitos dos fármacos , Plântula/crescimento & desenvolvimento , Sementes/efeitos dos fármacos , Sementes/crescimento & desenvolvimento , Biomassa , Produtos Agrícolas/efeitos dos fármacos , Produtos Agrícolas/crescimento & desenvolvimento , Germinação/efeitos dos fármacos , Folhas de Planta/efeitos dos fármacos , Folhas de Planta/crescimento & desenvolvimento , Plantas Daninhas/efeitos dos fármacos , Triticum/efeitos dos fármacos , Triticum/crescimento & desenvolvimento , Controle de Plantas Daninhas/métodosRESUMO
The purpose of this research was the development and optimization of mouth dissolving tablets (MDT) of Tizanidine hydrochloride using superdisintegrant. MDTs of Tizanidine (4mg) were manufactured by direct compression method. Formulations comprised of Tizanidine and excipients including croscarmellose sodium, Avicel PH 102, aspartame, orange flavor and magnesium stearate. Blends of powder were assessed for flow characterization and then compressed by direct compression. During post compression stage, a detail evaluation of tablets with respect to weight variation, hardness, thickness, disintegration time, wetting time, friability, drug content analysis, content uniformity, palatability and dissolution studies was carried out. All the formulations complied with the pharmacopeial requirements of weight, disintegration time and assay. Amongst the trial formulations F4 with concentration of croscarmellose sodium i.e. 5% was proved as best optimized due to satisfactory quality attributes such as least disintegration time and sufficient hardness. Hence, it was concluded that manufacturing of mouth dissolving tablets by addition of superdisintegrant is beneficial for treating patients with dysphagia.
Assuntos
Analgésicos/síntese química , Clonidina/análogos & derivados , Composição de Medicamentos/métodos , Administração Oral , Analgésicos/administração & dosagem , Analgésicos/metabolismo , Clonidina/administração & dosagem , Clonidina/síntese química , Clonidina/metabolismo , Força Compressiva , Humanos , Solubilidade , ComprimidosRESUMO
Methylphenidate is a psychostimulant used for the treatment of (ADHD) attention deficit hyperactivity syndrome in children and adults. After chronic administration it is known to produce behavioral disorders including anxiety. Previous studies demonstrated that co-administration of buspirone can reduce behavioral and cognitive adverse effects produced by methylphenidate. The aim of the present study is to measure the levels vanillylmandelic acid (VMA) excretion in urine following prolong administration of methylphenidate, buspirone and their combination. Samples of urine for the estimation of the urinary VMA excretion were collected from treated and control male Wistar rats. We found significant (P<0.01) raised urinary VMA excretion in methylphenidate group however significant (P<0.01) reduction in VMA levels were seen after buspirone co-administration. Excretion of VMA in urine would allow the monitoring of sympatho-adrenomedullary system activity. This study could be helpful to increase the clinical use of methylphenidate in the treatment of different disoders.
Assuntos
Buspirona/farmacocinética , Metilfenidato/farmacocinética , Ácido Vanilmandélico/urina , Animais , Buspirona/administração & dosagem , Masculino , Metilfenidato/administração & dosagem , Ratos WistarRESUMO
A Simple, sensitive and accurate high-performance liquid chromatographic (HPLC) method for effective and specific analysis of Loxoprofen (LXP) in the mobilephase and human plasma was developed. Effective chromatographic separation was attained on a Mediterranean Sea C18 column (250×4.6mm, 5um) with mobilephase containing acetonitrile and 0.01 M NaH2PO4 buffer (55:45) by adjusting pH 6.5 with sodium dihydrogen phosphate buffer at a flow rate of 1ml/min. Calibration ranges from 0.1ppm to 10 ppm with a coefficient of relation value (R2=0.999) by using a linear regression method and lower limit of quantification was 0.1ppm. The current method showed inter-day and intra-day accuracy and precision within the range of ±10%. % RSD was found to be less than 5 %. Analytical recovery was more than 90% which confirmed the reliability of current method. The proposed method was found appropriate for assessment of LXP in pharmacokinetic and bioequivalence study.
Assuntos
Anti-Inflamatórios não Esteroides/análise , Anti-Inflamatórios não Esteroides/sangue , Química Farmacêutica/normas , Fenilpropionatos/análise , Fenilpropionatos/sangue , Química Farmacêutica/tendências , Cromatografia Líquida de Alta Pressão/normas , Cromatografia Líquida de Alta Pressão/tendências , Humanos , Reprodutibilidade dos TestesRESUMO
The objective of present study was to develop and evaluate polyethylene glycol (PEG) based diclofenac sodium suppositories. This study used water soluble PEG bases (1000, 4000 and 6000) in different combinations to formulate suppositories, which were further subjected for their physicochemical properties evaluation such as weight variation, average melting point, content uniformity and disintegration. Dissolution test was used to perform the in vitro release rate studies of the suppositories. The suppository (P3) containing PEG-6000 (50%) and PEG-4000 (50%) exhibited rapid in vitro release rate of diclofenac sodium. Moreover, homogeneous distribution of diclofenac sodium is found in all six formulations. The in vitro release patterns of diclofenac sodium from the marketed Voltral suppository (100mg) and formulated suppositories were also compared and found in standard limits.
Assuntos
Diclofenaco/farmacocinética , Desenvolvimento de Medicamentos/métodos , Polietilenoglicóis/farmacocinética , Supositórios/farmacocinética , Diclofenaco/síntese química , Avaliação Pré-Clínica de Medicamentos/métodos , Polietilenoglicóis/síntese química , Supositórios/síntese químicaRESUMO
A precise, sensitive and quick High Performance Liquid Chromatographic (HPLC) method for the determination of rosuvastatin calcium in bulk and tablet dosage forms has been validated. The chromatographic scheme involved: Sil-20A auto sampler, LC-20A pump, SPD-20A UV/visible detector with separation attained by C18 column at 40ºC temperature through a mobile phase of acetonitrile and buffer (50:50) at a flow rate of 1.0ml/min. The method is precise (%RSD for intra-day and inter-day extended between 1.06-1.54% and 0.103-1.78%) and linear (r2=0.9997). Limit of detection and quantification (LOD & LOQ) of the adopted method were 0.78 and 1.56µg/ml. The proposed HPLC method was established to be sensitive, precise and swift that can be proficiently adopted in quality control/quality assurance laboratories for predictable investigation of the bulk and oral solid dosage forms of rosuvastatin calcium.
Assuntos
Anticolesterolemiantes/análise , Anticolesterolemiantes/química , Rosuvastatina Cálcica/análise , Rosuvastatina Cálcica/química , Tecnologia Farmacêutica/normas , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida de Alta Pressão/normas , Formas de Dosagem , Comprimidos , Tecnologia Farmacêutica/métodosRESUMO
A swift, precise and simple HPLC bioanalytical technique with UV detection was established and validated for quantitative estimation of valsartan in human plasma. The analyte was separated from plasma by protein precipitation with acetonitrile and chromatographically separated on Zorbax SB-C18 (5µm, 4.6mm × 15cm) column. The solvent mixture system consisting of acetonitrile, water and glacial acetic acid (40:59:1 v/v), was pumped using isocratic mode at 1mL/min flow rate. Samples' detection of drug was made spectrophotometrically at a wavelength of 264nm. The analyte response was instituted to be linear from 0.06 to 8µg/mL with a regression value of 0.999. The accuracy of the proposed method was ranged between 97.2-100.3% with 5% RSD. The analytical recovery (>95%) was consistently observed and satisfactory sample stability was also found at different environmental conditions. In conclusion the reported bio-analytical method is easy and robust that was successfully utilized in estimation of valsartan in a pharmacokinetic study.
Assuntos
Bloqueadores do Receptor Tipo 1 de Angiotensina II/sangue , Cromatografia Líquida de Alta Pressão , Espectrofotometria Ultravioleta , Valsartana/sangue , Bloqueadores do Receptor Tipo 1 de Angiotensina II/farmacocinética , Calibragem , Cromatografia Líquida de Alta Pressão/normas , Humanos , Limite de Detecção , Masculino , Padrões de Referência , Reprodutibilidade dos Testes , Espectrofotometria Ultravioleta/normas , Valsartana/farmacocinéticaRESUMO
This assessment aims to determine the prevalence of methicillin resistance and multidrug resistance (MDR) among the clinical isolates of Staphylococcus aureus and antimicrobial susceptibility profile of methicillin resistant Staphylococcus aureus (MRSA) to the frequently prescribed antibiotics in Karachi. Isolates of MRSA, recovered from various clinical samples were included in this prospective, cross-sectional study from Jan 2015 to June 2017. Agar diffusion method was employed according to the protocols of Clinical Laboratory Standards Institute. Out of total 346 S. aureus strains, the frequency rate of MRSA was 52% (n = 180). MRSA infection was found higher among the age group 21-30 years i.e. 30% (n=54), followed by 20% (n=36) in 31-40 years. Frequency of MRSA percentage in male and female was and 70% and 30% respectively. MRSA was more frequently observed in blood 20% (n=36). MRSA showed high resistance (100%) to Oxacillin and Cefoxitin while 25% Vancomycin resistant S. aureus (VRSA) isolates and 25% Teicoplanin resistance were also reported. MRSA exhibited 16% resistance to Minocycline. It was concluded that MRSA pose a challenging threat to public health in Karachi. In addition, MDR should be periodically checked to avoid treatment failure.
Assuntos
Antibacterianos/uso terapêutico , Farmacorresistência Bacteriana Múltipla , Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Criança , Pré-Escolar , Estudos Transversais , Testes de Sensibilidade a Antimicrobianos por Disco-Difusão , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Staphylococcus aureus Resistente à Meticilina/patogenicidade , Pessoa de Meia-Idade , Paquistão/epidemiologia , Prevalência , Estudos Prospectivos , Distribuição por Sexo , Infecções Estafilocócicas/diagnóstico , Infecções Estafilocócicas/microbiologia , Resultado do Tratamento , Adulto JovemRESUMO
The aim of the study was to develop a reservoir-type transdermal patch for a controlled delivery of dexibuprofen and to evaluate its in vivo anti-inflammatory activity in Albino Wistar rats. In order to develop these patches, six formulations of dexibuprofen microemulsion comprising ethyl oleate, Tween 80: PG (2 : 1), and water were prepared by simplex lattice design and characterized. The reservoir compartment was filled with these microemulsions and in vitro release and skin permeation were assessed. The optimized patch was obtained on the basis of the responses: Q24 and flux. The impact of drug loading, surface area, membrane thickness, adhesive, and agitation speed on drug release and permeation was also studied. The skin sensitivity reaction and in vivo anti-inflammatory activity of optimized patch were evaluated. Stability study at three different temperatures for three months was carried out. The result suggests that a membrane based patch with zero-order release rate, Q24 of 79.13 ± 3.08%, and maximum flux of 331.17 µg/cm2h can be obtained exhibiting suitable anti-inflammatory activity with no visible skin sensitivity reaction. The outcomes of stability study recommend storage of patches at 4°C having shelf-life of 6.14 months. The study demonstrates that the reservoir-type transdermal patch of dexibuprofen microemulsion has a potential of delivering drug across skin in controlled manner with required anti-inflammatory activity.
Assuntos
Ibuprofeno/análogos & derivados , Absorção Cutânea/efeitos dos fármacos , Administração Cutânea , Animais , Preparações de Ação Retardada/química , Preparações de Ação Retardada/farmacocinética , Preparações de Ação Retardada/farmacologia , Emulsões , Ibuprofeno/química , Ibuprofeno/farmacocinética , Ibuprofeno/farmacologia , Ratos , Ratos WistarRESUMO
A new, simple, accurate, precise and specific method has been developed for the analysis of Cefpodoxime Proxetil in human plasma. The proposed method was developed and validated with the aim to be used in Bioavailability/Bioequivalence studies for quantification of drug in human plasma. The mobile phase components were acetonitrile, methanol, and water in the ratio of 20:50:30. Ortho phosphoric acid was used to adjust at pH5.0. Flow rate and wavelength were kept 1ml/min and 247nm respectively. The column was C-18 HPLC column 5um particle size, L x 1.d. 25cm x4.6mm. (Supelcosil). Retention time of Cefpodoxime Proxetil was found to be 10.967min. The developed method was validated for selectivity, recovery, accuracy, precision, repeatability, reproducibility, stability and linearity in the range of 0.195mcg/ml to 50mcg/ml. The accuracy and Precision of the proposed method were well within the predefined limits i.e. ±15% for all the calibration standards other than LLOQ (Lower Limit of Quantification) where it was well within ±20% of the nominal value. The analytical recovery was always above 89% showing satisfactory recovery. The coefficient of correlation (R2 ) was 0.999. The developed method was found suitable for the estimation of Cefpodoxime Proxetil in plasma.
Assuntos
Antibacterianos/sangue , Ceftizoxima/análogos & derivados , Cromatografia Líquida de Alta Pressão , Calibragem , Ceftizoxima/sangue , Cromatografia Líquida de Alta Pressão/normas , Humanos , Limite de Detecção , Padrões de Referência , Reprodutibilidade dos Testes , Cefpodoxima ProxetilRESUMO
Cefaclor was analyzed in the human plasma by developing a simple, precise and accurate assay method which was then validated for its accuracy, specificity and precision. The mobile phase comprised of a mixture of sodium 1-pentanesulfonate, water, triethylamine and methanol. Phosphoric acid was used to adjust the pH to 2.5±0.1. The flow rate was maintained at 1.5ml/min and the wavelength was set at 265 nm. A C-18 HPLC, column 5um particle size, L x 1.D. 25cm x 4.6mm (Supelcosil) was utilized for chromatographic separation. The retention time of Cefaclor was found to be 17min. This method was validated for selectivity, accuracy, precision, repeatability, reproducibility, recovery, linearity, and stability. Calibration curves were found linear were in the range of 0.39µg/ml to50µg/mland the coefficient of correlation (R2) was found to be 0.999. Hence, this method has been found useful for the determination of Cefaclor in plasma.
Assuntos
Antibacterianos/sangue , Cefaclor/sangue , Cromatografia Líquida de Alta Pressão/métodos , Calibragem , Cromatografia Líquida de Alta Pressão/normas , Humanos , Limite de Detecção , Padrões de Referência , Reprodutibilidade dos TestesRESUMO
In the present work a specific, accurate, precise, and reproducible UV-HPLC method was developed and validated for the analysis of Aceclofenac. This method involved elution of Aceclofenac in a mobile phase which is composed of buffer pH 6.8 (i.e. using 0.01N KH2PO4) and HPLC grade Acetonitrile (60:40). Separation of the analyte was achieved using HPLC isocratic pump attached to the UV-VIS detectorC18, guard column and C18 column. The injection volume was 20µL, detected at 274 nm; flow rate: 1mL/min. Standard calibration curve was measured and found linear from 0.1 to 40µg/ml. The validation parameters were measured according to FDA guidelines and successful results were obtained. The presented analytical method could be employed for pharmacokinetic studies.
Assuntos
Anti-Inflamatórios não Esteroides/análise , Cromatografia Líquida de Alta Pressão , Cromatografia de Fase Reversa , Diclofenaco/análogos & derivados , Solventes/química , Água/química , Calibragem , Cromatografia Líquida de Alta Pressão/normas , Cromatografia de Fase Reversa/normas , Diclofenaco/análise , Padrões de Referência , Reprodutibilidade dos Testes , Solubilidade , Espectrofotometria UltravioletaRESUMO
The objective of the present work was to develop Immediate Release (IR) tablets of Metoprolol Tartrate (MT) and to compare trial formulations to a reference product. Six formulations (F1-F6) were designed using central composite method and compared to a reference brand (A). Two marketed products (brands B and C) were also evaluated. F1-F6 were prepared with Avicel PH101 (filler), Crospovidone (disintegrant) and Magnesium Stearate (lubricant) by direct compression. Pharmacopoeial and non-pharmacopoeial methods were used to assess their quality. Furthermore, drug profiles were characterized using model dependent and independent (f(2)) approaches. Brands B and C and F5 and F6 did not qualify the tests for content uniformity. Moreover, brand B did not meet weight variation criteria and brand C did not satisfy requirements for single point dissolution test. Of the trial formulations, F2 failed the test for uniformity in thickness while F4 did not disintegrate within time limit. Only F1 and F3 met all quality parameters and were subjected to accelerated stability testing without significant alterations in their physicochemical characteristics. Based on AIC and r(2)(adjusted) values obtained by applying various kinetic models, drug release was determined to most closely follow Hixson-Crowell cube root law. F1 was determined to be the optimized formulation.
Assuntos
Antagonistas de Receptores Adrenérgicos beta 1/química , Metoprolol/química , Administração Oral , Antagonistas de Receptores Adrenérgicos beta 1/administração & dosagem , Celulose/química , Química Farmacêutica , Excipientes/química , Cinética , Metoprolol/administração & dosagem , Modelos Químicos , Povidona/química , Pressão , Solubilidade , Ácidos Esteáricos/química , Comprimidos , Tecnologia Farmacêutica/métodosRESUMO
Objectives. To determine the demographics and analyze the management and factors influencing the postoperative complications of hypospadias repair. Settings. Hayatabad Medical Complex Peshawar, Pakistan, from January 2007 to December 2011. Material and Methods. All male patients presenting with hypospadias irrespective of their ages were included in the study. The data were acquired from the hospital's database and analyzed with Statistical Package for Social Sciences (SPSS). Results. A total of 428 patients with mean age of 8.12 ± 5.04 SD presented for hypospadias repair. Midpenile hypospadias were the most common. Chordee, meatal abnormalities, cryptorchidism, and inguinal hernias were observed in 74.3%, 9.6%, 2.8%, and 2.1% cases, respectively. Two-stage (Bracka) and TIP (tubularized incised urethral plate) repairs were performed in 76.2% and 20.8% of cases, respectively. The most common complications were edema and urethrocutaneous fistula (UCF). The complications were significantly lower in the hands of specialists than residents (P-value = 0.0086). The two-stage hypospadias repair resulted in higher complications frequency than single-stage repair (P value = 0.0001). Conclusion. Hypospadias surgery has a long learning curve because it requires a great deal of temperament, surgical skill and acquaintance with magnifications. Single-stage repair should be encouraged wherever applicable due to its lower postoperative complications.
RESUMO
Cefuroxime axetil immediate release tablets were formulated by direct compression method with different percentages of sodium lauryl sulphate (SLS) such as 0.5, 1.0, 1.5 and also without SLS. Resulting batches of tablets were evaluated by both pharmacopeial and non-pharmacopeial methods to ascertain the physico-mechanical properties. Dissolution test were carried out in different medium like 0.07 M HCl, distilled water, 0.1M HCl of pH 1.2 and phosphate buffers at pH 4.5 and 6.8 to observe the drug release against the respective concentration of SLS used. Later, test formulations were compared by f1 (dissimilarity) and f2 (similarity) factors using a reference brand of cefuroxime axetil. Significant differences (p<0.05) in dissolution rate were recorded with the change in concentration of SLS in different media. Test formulation T3 containing 1% SLS was found to be best optimized formulation based on assay, disintegration, dissolution and similarity and dissimilarity factors.
Formularam-se comprimidos de liberação imediata à base de cefuroxima axetil, pelo método de compressão direta, com diferentes percentagens de lauril sulfato de sódio (LSS), tais como 0,5, 1,0, 1,5, e também sem SLS. Os lotes resultantes dos comprimidos foram avaliados por ambos os métodos da farmacopeia e não farmacopeicos para determinar as propriedades físico-mecânicas. O teste de dissolução foi realizado em meios diferentes, como HCl 0,07 M, água destilada, HCl 0,1 M com pH 1,2 e os tampões fosfato (pH 4,5 e 6,8) para observar a liberação do fármaco contra a correspondente concentração de LSS utilizado. Em seguida, as formulações de teste foram comparadas por fatores f1 (dissimilaridade) e f2 (similaridade), utilizando uma marca de referência de cefuroxima axetil. Diferenças significativas (p<0,05) na taxa de dissolução foram registradas com a mudança na concentração de LSS em diferentes meios de dissolução. A formulação T3 contendo LSS a 1% foi considerada a melhor formulação otimizada com base nos ensaios de desintegração, dissolução e fatores de semelhança e dissimilaridade.
Assuntos
Dodecilsulfato de Sódio/análise , Comprimidos/classificação , Cefuroxima/análise , Química FarmacêuticaRESUMO
BACKGROUND: Submucous cleft palate is characterized by muscular diastasis of the velum in the presence of intact mucosa with variable combinations of bifid uvula and hard palatal defect. Submucous cleft palate is indicated as a separate entity in most previous classifications but it has never been properly classified on an anatomical basis. OBJECTIVES: To revise the Smith-modified Kernahan 'Y' classification of cleft lip and palate deformities, and to describe the different anatomical subtypes of submucous cleft palate. METHODS: The present study was conducted in Hayatabad Medical Complex, Abasin Hospital and Aman Hospital Peshawar, Pakistan, from November 2010 to December 2011. All patients who presented to the outpatient departments with cleft lip and palate, with the exception of previously operated cases, were included. All cases were described according to the Smith-modified Kernahan 'Y' classification and the authors' revised Smith-modified Kernahan 'Y' classification. All of the data were organized and analyzed using SPSS version 17 (IBM Corporation, USA). RESULTS: A total of 163 cases of cleft lip and palate deformities were studied, of which 59.5% were male and 40.5% were female. Smith modification of the Kernahan 'Y' classification completely described the cleft deformities in 93.9% of patients. However, while the Kernahan 'Y' classification represented the submucous cleft palate, it did not describe its different anatomical subtypes in 6.13% of patients. The revised Smith-modified Kernahan 'Y' classification completely described the cleft deformities of the entire study population, including the different submucous cleft palate patients. DISCUSSION: The Smith alphanumeric modification of the Kernahan 'Y' classification of cleft lip and palate came into existence after a long search and a series of modifications over the past century. This classification system describes the cleft region, site of the cleft, degree of the cleft, rare and asymmetrical clefts, and are computer database friendly. However, this classification did not describe the different anatomical subtypes of submucous cleft palate that have variable relationships with velopharyngeal insufficiency. CONCLUSION: The revised Smith-modified Kernahan 'Y' classification described in the present study can describe all types of cleft lip and palate deformities in addition to the different types of submucous cleft palate deformities.
HISTORIQUE: La fente palatine sous-muqueuse se caractérise par un diastasis musculaire du voile du palais en présence d'une muqueuse intacte comportant diverses combinaisons de luette bifide et d'anomalie du palais dur. La fente palatine sous-muqueuse était considérée comme une entité distincte dans la plupart des classifications antérieures, mais on ne lui a jamais attribué de classification convenable sur le plan anatomique. OBJECTIFS: Examiner la classification en « Y ¼ de Kernahan modifiée par Smith des fentes labiales et palatines et décrire les divers sous-types anatomiques de la fente palatine sous-muqueuse. MÉTHODOLOGIE: La présente étude a été menée au complexe médical Hayatabad de Peshawar, à l'hôpital Abasin de Peshawar et à l'hôpital Aman de Peshawar, au Pakistan, de novembre 2010 à décembre 2011. Tous les patients qui se sont présentés aux consultations externes et qui avaient une fente labiale et palatine ont participé à l'étude, à l'exception des cas déjà opérés. Les auteurs ont décrit tous les cas conformément à la classification en « Y ¼ de Kernahan modifiée par Smith et à leur révision de cette classification. Ils ont organisé et analysé toutes les données à l'aide du logiciel SPSS, version 17 (IBM Corporation, États-Unis). RÉSULTATS: Au total, les chercheurs ont étudié 163 cas de fentes labiales et palatines, répartis entre 59,5 % d'hommes et 40,5 % de femmes. La classification en « Y ¼ de Kernahan modifiée par Smith décrivait tous les éléments des anomalies palatines chez 93,9 % des patients. Cependant, même si la classification en « Y ¼ de Kernahan incluait la fente palatine sous-muqueuse, elle n'en décrivait pas les divers sous-types anatomiques chez 6,13 % des patients. La classification en « Y ¼ de Kernahan modifiée par Smith et révisée décrivait tous les éléments des anomalies palatines de toute la population à l'étude, y compris chez les patients ayant diverses fentes palatines sous-muqueuses. EXPOSÉ: La modification alphanumérique par Smith de la classification en « Y ¼ de la fente labiale et palatine de Kernahan a été créée après de longues recherches et une série de modifications apportées sur une periode d'un siècle. Ce système de classification décrit la région, le foyer et le degré de la fente ainsi que les fentes rares et asymétriques, et il est adapté aux bases de données informatiques. Cependant, il ne décrivait pas les divers sous-types de fente palatine sous-muqueuse qui ont des relations variables avec l'insuffisance vélopharyngée. CONCLUSION: La classification en « Y ¼ de Kerhanahn modifiée par Smith décrite dans la présente étude peut décrire tous les types de fentes labiales et palatines, en plus des divers types de fentes palatines sous-muqueuses.