Current Issue : January - March Volume : 2012 Issue Number : 1 Articles : 8 Articles
The bioavailability of a single dose of ciprofloxacin 1000 mg Extended release (XR) tablets manufactured by a Jordanian manufacturer (Hikma PLC), was compared with a reference ciprofloxacin 1000 mg XR tablets (Cipro�® XR, Bayer-health care, Germany) in two different studies (under fasting and fed conditions). In each study, 28 healthy, male, Jordanian volunteers were enrolled. However, only 25 subjects in fasting study and 23 subjects in fed study completed the crossover. Each study was designed as single-center, open-label, randomized, singledose, two-way crossover study. Nineteen blood samples were taken during 24hrs. Samples were frozen and kept until time of analysis. Ciprofloxacin concentrations in subjects' plasma were determined by using a validated HPLC fluorescence technique. Confidence intervals (90%) for the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed Test/Reference ratio using standard non-compartmental method and ANOVA statistics. The 90% CI result in fasting study for Cmax was 88.87 (82.17 - 96.10)% and for AUC0-t was 87.60 (80.38-95.46)%. In fed study the results were 102.09 (92.77-112.34)% and 104.06 (100.01-108.27)% for Cmax and AUC0-t, respectively. In conclusion, it is evident that the 90% CI for the primary pharmacokinetics parameters was within the bioequivalence acceptable boundaries of 80-125%, while for AUC0-t, and 75.-133% for Cmax. Therefore, it was concluded that both products were bioequivalent....
A near infrared (NIR) method able to directly quantify the active content in pharmaceutical powder blends used for manufacturing meloxicam tablets, without any sample preparation, was developed and fully validated. To develop calibration models for the assay of meloxicam in powder blends for tableting, the NIR reflectance spectra of different meloxicam powder blends prepared according to a calibration protocol was analysed using different preprocessing methods by partial last-square regression (PLS) and principal component regression (PCR).\nThe best calibration model was found when partial last-square regression (PLS) was used as regression algorithm in association with Smoothing-Savitsky as pre-processing spectrum method. The trueness, precision (repeatability and intermediate precision), accuracy, linearity and range of application of the developed NIR method were validated according to the International Conference of Harmonization (ICH) and Medicine European Agency (EMA) guidelines and found to be fit for its intended purpose....
Niosomes represent a promising targeted drug delivery system for hydrophilic and lipophilic drugs. They present a structure similar to liposome and hence they can be an alternative vesicular system with respect to liposomes. Due to the niosome ability to encapsulate different type of drugs within their multi environmental structure they can be exploited for various treatment of various diseases. Niosomes can be a better drug delivery system as compared to liposomes due to various factors like cost, stability. Various routes of drug delivery and drug targeting can be achieved using niosomes....
Chitosan (CS) nanoparticles have been developed as a versatile drug delivery system to transport drugs, genes, proteins, and peptides into target sites. Demands on fluorescent nanoparticles have increased recently due to various applications in medical and stem-cell-based researches. In this study, fluorescent CS nanoparticles were prepared by a mild method, namely, complex coacervation. Entrapment efficiency of sulforhodamine (SR101) loaded into CS nanoparticles was investigated to evaluate their capacity in incorporating fluorescent molecule. Particle size of produced fluorescent nanoparticles was in the range of 600ââ?¬â??700?nm, and their particle size was highly dependent on the CS molecular weight as well as concentration. A high entrapment efficiency of SR101 into CS nanoparticles could also be obtained when it was dissolved in methanol. In conclusion, highly loaded fluorescent CS nanoparticles could be easily prepared using complex coacervation method and therefore can be applied in various medical researches....
A novel approach of drug delivery system is towards pulsatile-release pattern. Pulsatile drug delivery is one such system that, deliver drug at the right time, right place and in right amounts, holds good promises of benefit to the patients. This system is receiving increasing interest for the development of drugs whose conventional controlled drug-release systems with a continuous release are not satisfactory. This system can be classified in multiple-pulse and single-pulse systems. A popular class of single-pulse systems is that of rupturable dosage forms other systems consist of a drug-containing core, covered by a swelling layer and an outer insoluble, but semi permeable polymer coating or membrane. Pulsatile drugs involve controlled drug-release systems with a continuous release at distinct time intervals that are programmed into the drug product. Since some diseases have a predictable cyclic rhythm, the timing of medication regimens can improve the outcome of a desired effect. This condition demands development of pulsatile drug delivery system. Thus a focus on the diseases requiring Pulsatile Drug Delivery System, methodologies involved for the existing systems, recent update and Pulsatile Drug Delivery system product has a vital importance....
Objective: The aim of this work was to study the relationship between the crystal form of Cefoperazone sodium (CPZ-Na) and its stability.\r\n Methods: To classify CPZ-Na into amorphous powder and crystalline, powder X-ray diffraction (PXRD) was used. To classify CPZ-Na crystal powder into crystal form A and B, thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC) were used. To further classify CPZ-Na crystal form A into different subtypes, clustering of PXRD data and scanning electron microscopy (SEM) were used. To compare the stability of CPZ-Na crystal form A and B, temperature controlled PXRD and high performance liquid chromatography (HPLC) were used.\r\n Results: CPZ-Na was classified into amorphous powder and crystalline, CPZ-Na crystal powder was classified into crystal form A and B, and CPZ-Na crystal form A was further classified into different subtypes. Moreover, the stability of CPZ-Na crystal form A was higher than that of crystal form B, and different subtypes of CPZ-Na crystal form A had different stability.\r\n Conclusions: There was a close relationship between the crystal form of CPZ-Na and its stability....
Tenofovir Disoproxil Fumarate, CAS 147127-20-6 is a nucleotide reverse transcriptase inhibitor with potent activity against both HIV and hepatitis B infections. Lamivudine, CAS 134678-17-4 is a nucleoside analogue reverse transcriptase inhibitor developed as a treatment for HIV infection and also with activity against hepatitis B virus. The combination of tenofovir and lamivudine associated either with non-nucleoside reverse transcriptase inhibitors or with a ritonavir-boosted or unboosted protease inhibitor are recommended as preferred regimens for antiretroviral therapy-na�¯ve patients infected with HIV, and also for the treatment of HIV-HVB coinfected patients. The objective of this study was to compare rate and extent of absorption and to assess the bioequivalence between a new pharmaceutical equivalent tablet formulation containing a fixed-dose combination of tenofovir disoproxil fumarate/ lamivudine 300/300 mg and the innovator products. A randomized, single-center, open-label, single-dose, two-way crossover bioequivalence study in 40 healthy adult subjects was conducted. Dosing was separated by a wash-out period of 14 days. All subjects signed an informed consent form. In each study period, 13 blood samples were collected in Vacutainers containing EDTA over 48 h. Plasma levels of tenofovir and lamivudine were determined by a validated HPLC/fluorescence assay and by a validated HPLC/UV assay, respectively. Rate and extent of absorption were similar between products. The 90% confidence interval(CI) of the ratio of the geometric means for log-transformed Cmax, AUClast and AUCinfvalues were used to assess bioequivalence between the two formulations using the equivalence interval of 80 and 125%. In healthy subjects, the point estimate and 90 % CI of the ratios of Cmax, AUClast and AUCinfvalues for tenofovir were 100.99%(92.89-109.80%), 96.11%(90.02-102.63%) and 94.73%(88.22-101.73%), respectively; and for lamivudine were 90.37%(83.76-97.50%), 97.02%(93.27-100.93%) and 97.04%(93.41-100.82%), respectively. Both treatments exhibited similar tolerability and safety. It was concluded that the new pharmaceutical formulation was bioequivalent to the innovators....
Embelin 2,5-dihydroxy-3-undecyl-1,4-benzoquinone, a chemical component available in dried fruits of Embelia ribes burm F. shows its anthelmintic activity against tapeworms. Embelin is practically insoluble in water. There is a need for solubility enhancement of Embelin in order to enhance its absorption through intestine. The study was aimed to formulate solid dispersions of Embelin by using various carriers (PVP, PVP- K 30, PEG 6000 & PEG 4000) in three different ratios (1:0.5, 1:1 and 1:1.5) using solvent evaporation technique. The prepared solid dispersions were characterized using infrared spectral studies, differential scanning calorimetric studies, aqueous solubility studies, drug content and in-vitro release profile. From FT-IR, XRD, and DSC studies no interaction between Embelin and carrier was observed. Solid dispersion of Embelin with PVP in 1:1 ratio showed maximum enhancement in the solubility of Embelin as well as % drug release after 2 hrs in phosphate buffer pH 7.4. Thus, the solid dispersion technique can be successfully used for improvement of solubility and dissolution profile of Embelin. Successful attempt was made to enhance the solubility of Embelin using solid dispersion technique....
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