Solubility enhancementofcefixime trihydrate by solid dispersions using hydrotropic solubilization technique and their characterization

Abstract The aqueous solubility of cefixime trihydrate (a water insoluble drug) using different hydrotropic agents was determined and solid dispersions of cefixime trihydrate were prepared by hydrotropic solubilization technique. The drugs content were determined. The aqueous solubility of v was increased many fold in presence of sodium acetate trihydrate as hydrotropic agent. This hydrotropic agent was used to prepare solid dispersion of cefixime trihydrate. Cefixime trihydrate and sodium acetate trihydrate were accurately weighed and taken in a 200 mL beaker. Distilled water 10-15 mL was taken to dissolve hydrotropic agent using heat (48-50 °C). The drug was then added to it and magnetically stirred till whole mass get viscous. The solid dispersions of cefixime trihydrate were characterized by XRD, DSC and IR studies. DSC thermogram, XRD and Infra-Red spectra were studied. Solid dispersions, thus prepared, showed faster release of the drug as compared to pure drug and physical mixture.

Simultaneous analysis of mometasone furoate, miconazole nitrate, and nadifloxacin in cream formulation by HPTLC

A simple and precise High performance thin layer chromatography method was developed for the simultaneousinvestigation of mometasone furoate (MOM), miconazole nitrate (MIC), and nadifloxacin (NAD). This method wasused to analyze three drugs in a cream formulation without the interference of excipients. HPTLC separation of thedrugs was achieved using the mobile phase system containing toluene, ethyl acetate, ethanol, and formic acid (10:3:2:0.5v/v/v/v) on a precoated aluminum plate of silica gel 60 F254 at 235 nm. Linearity was achieved over the range of 60–220,1,200–4,400, and 600–2,200 ng/band, with mean accuracy of 99.004 ± 1.008, 99.182 ± 1.324, and 99.169 ± 1.421 forMOM, MIC, and NAD, respectively. The limits of detection (ng/band)were found to be 14.075, 326.945, and 191.611,and the limits of quantification (ng/band) were 42.653, 990.741, 580.639 for MOM, MIC, and NAD, respectively,which show the sensitivity of the method. After successful development and validation, the established method wasused for the assessment of mometasone furoate, miconazole nitrate, and nadifloxacin in 3 Mix cream.

Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods.

Three new UV spectrophotometric methods namely simultaneous equation, absorbance ratio and first derivative (zero crossing) spectroscopic methods were developed and validated for simultaneous estimation of teneligliptin hydrobromide hydrate and metformin hydrochloride in tablet formulation which were simple, sensitive, precise and accurate. In simultaneous equation method, absorbance was measured at 237 and 246 nm for both the drugs. Teneligliptin hydrobromide hydrate and metformin hydrochloride was estimated using 237 and 247.5 nm in absorbance ratio method. First derivative (zero crossing) method was based on the transformation of UV spectra in to first derivative spectra followed by measurement of first derivative signal at 237 and 246 nm for teneligliptin hydrobromide hydrate and metformin hydrochloride, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor. Developed methods were validated according to ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, limit of detection and quantification. All the three methods showed linear response in the concentration range of 1-20 µg/ml for both the drugs. Results of method validation parameters follows ICH guideline acceptable limits. Based on the assay results obtained, methods were compared using one-way ANOVA followed by Bonferroni multiple comparison tests (95% confidence level) using computer based fitting program (Prism, Graphpad version 5, Graphpad Software Inc). Outcome of the statistical analysis proved that there was no considerable dissimilarity between all the developed methods. Methods were found to be simple, fast, highly sensitive, cost effective and hence can be useful for simultaneous estimation of teneligliptin hydrobromide hydrate and metformin hydrochloride in commercial tablet formulation for routine quality control analysis.

Simultaneous estimation of Aliskiren hemifumarate and Hydrochlorothiazide in combined Tablet Formulation by Simultaneous equation, Absorbance ratio and First derivative Spectroscopic Methods.

Three simple, sensitive, precise and accurate UV-spectroscopic methods namely simultaneous equation, absorbance ratio and first derivative (zero crossing) spectroscopic methods were developed and validated for simultaneous determination of aliskiren hemifumarate and hydrochlorothiazide in tablet dosage form. Simultaneous equation method was based on the measurement of absorbance at 271 and 280 nm for both the drugs. In absorbance ratio method 255 and 271 nm was used for the quantification of aliskiren hemifumarate and hydrochlorothiazide. First derivative method was involved in the conversion of UV-spectra in to first derivative spectra and measurement of first derivative signal at 241 and 280.2 nm for aliskiren hemifumarate and hydrochlorothiazide, respectively using 2 nm as wavelength interval (Δλ) and 1 as scaling factor. Methods were validated as per ICH guidelines including parameters viz., specificity, linearity and range, precision, accuracy, limit of detection and quantification. All the methods were found to be linear in the concentration range of 6-300 μg/ml for aliskiren hemifumarate and 0.5-25 μg/ml for hydrochlorothiazide. Results of validation studies follows ICH guideline acceptable limits. Methods were compared based on the assay results obtained using one-way ANOVA followed by Bonferroni multiple comparison tests (95% confidence level) as appropriate using computer based fitting program (Prism, Graphpad version 5, Graphpad Software Inc). Results of statistical analysis revealed that there was no significant difference between simultaneous equation, absorbance ratio and first derivative method. Developed methods were simple, rapid, highly sensitive and cost effective as compared to existing methods and can be useful for simultaneous estimation of aliskiren hemifumarate and hydrochlorothiazide in commercial tablet formulation for routine quality control.

Evaluation of Arthroscopic Anterior Cruciate Ligament Reconstruction using Hamstring Graft.

To evaluate the results of quadrupled hamstring tendon autograft Anterior Cruciate Ligament (ACL) reconstruction fixed with bioabsorbable interference screw fixation. Methods: Twenty-five patients underwent arthroscopic anterior cruciate ligament reconstructions using autogenous hamstring graft (semitendinosis and gracilis). All patients underwent through standard surgical procedure and rehabilitation protocol. Patients were assessed using International Knee Documentation Committee (IKDC) and Lysholm knee scoring scale at a minimum duration of six-month. Results: In all patients at 6 months post surgery. The mean Lysolm knee score was 91.2 (range, 63 to 99) and the mean IKDC score was 90.7 (range, 60 to 98). Conclusion: The short-term results were quite promising on evaluation with IKDC and Lysholm scale.

Solubilization of Poorly Water Soluble Drug Using Mixed Solvency Approach for Aqueous Injection.

Aim: 1) To increase water solubility of indomethacin drug using mixed solvency approach. 2) To employ use of non toxic solubilizers for increasing solubility of a poorly water soluble drug. Study Design: Trial and error based experimental study. Place and Duration of Study: School of Pharmacy, Devi Ahilya Vishwavidyalaya, UTD, Takshashila Campus, Indore, India and College of Pharmacy, IPS Academy, Indore, India between Jan. 2011 and June. 2012. Methodology: By making mixed solvent (40%) blends of selected water soluble substances from the hydrotropes (urea, sodium benzoate, sodium citrate, nicotinamide); water-soluble solids (PEG- 4000, PEG-6000); and co-solvents (propylene glycol, glycerine, PEG-200, PEG-400, PEG 600) solubility studies were performed with indomethacin (model drug). On the basis of solubility studies formulation was developed. The solubilized drug and prepared formulation were characterized by ultraviolet and infrared techniques. Various properties of solution such as pH, viscosity, specific gravity and surface tension were studied. The developed formulation was studied for physical and chemical stability. Result: Aqueous solubility of drug in case of selected blends ranged from 14.55 mg/ml – 19.96 mg/ml (as compared to the solubility in distilled water 0.0464 ± 0.007 mg/ml). The enhancement in the solubility of drug in a mixed solvent containing 10% sodium benzoate, 5% sodium citrate and 25 % S cosolvent (25% S cosolvent contains PEG200, PEG 400, PEG600, Glycerine and Propylene glycol) was more than 400 fold. Prepared formulation F10 show appreciable physical and chemical stability. Conclusion: The results of this study provide guidance for developing an injectable product and strategies for improving solubility as well as stability of poorly water soluble drug using the concept of mixed solvency. The proposed technique is economical, convenient and safe. The application of mixed solvency approach in the development of formulations shall prove a boon for pharmaceutical industries.

Epidural Steroid Injection in Lumbar Disc Herniation.

Low back pain is a problem that is common and costly to society and its effective management remains a challenge. Major cause of morbidity due to low back pain is prolapsed intervertebral disc which mostly affects young adults in their fourth decade of life. Epidural steroid injection (ESI) is a low-risk alternative to surgical intervention in the treatment of lumbar disc herniation. This follow up study was planned to know the results of epidural injections with corticosteroids in symptomatic patients of lumbar disc prolapse. Out of 159 patients who were evaluated before and after the ESI for pain relief, 78% had positive response. No major post-injection complications were reported in this study. Carefully administered epidural steroid injection is a safe and effective modality in the treatment of pain in lumbar disc herniation.