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Gel Formulation (gel + formulation)

Distribution by Scientific Domains

Medical Sciences	69%

Selected Abstracts

A Novel Gel Formulation of 0.25% Tretinoin and 1.2% Clindamycin Phosphate: Efficacy in Acne Vulgaris Patients Aged 12 to 18 Years

PEDIATRIC DERMATOLOGY, Issue 3 2009
Lawrence F. Eichenfield M.D.
Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12-week, multicenter, double-blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52-week safety follow-up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA's effects on acne lesion prevalence in 12- to 18-year-old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p , 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris. [Abstract amended after online publication date June 8, 2009] [source]

Thiomers in noninvasive polypeptide delivery: In vitro and in vivo characterization of a polycarbophil-cysteine/glutathione gel formulation for human growth hormone

JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 7 2004
Verena M. Leitner
Abstract This study was aimed at investigating the potential of a new polycarbophil-cysteine (PCP-Cys)/glutathione (GSH) gel formulation to enhance the permeation of the model drug human growth hormone (hGH) across nasal mucosa in vitro and in vivo. The aqueous nasal gel contained PCP-Cys, GSH, and hGH in a final concentration of 0.3%, 0.5%, and 0.6% (m/v), respectively. In vitro permeation studies were performed in Ussing chambers on freshly excised bovine nasal mucosa using fluorescence-labeled dextran (molecular mass: 4.3 kDa; FD-4) and hGH (FITC-hGH). The release profile of FITC-hGH from the gel formulation and an unmodified PCP control formulation was determined. Furthermore, in vivo studies in rats were performed comparing the PCP-Cys/GSH/hGH gel with PCP/hGH control gel and physiological saline. The permeation of FD-4 and FITC-hGH across the nasal mucosa was improved two-fold and three-fold, respectively, in the presence of PCP-Cys/GSH. The PCP-Cys/GSH/hGH gel and the PCP/hGH control gel showed the same biphasic and matrix-controlled drug release. The nasal administration of the PCP-Cys/GSH/hGH gel formulation to rats resulted in a significantly increased and prolonged hGH plasma concentration,time profile versus unmodified PCP gel and physiological saline. According to these results, PCP-Cys gels might represent a promising new strategy for systemic nasal polypeptide delivery. © 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1682,1691, 2004 [source]

Efficacy of topical griseofulvin in treatment of tinea corporis

MYCOSES, Issue 3 2006
Mohamed A. A. Kassem
Summary Tinea infections are among the most common dermatological conditions throughout the world. Griseofulvin is a classical oral fungistatic antibiotic, active against Epidermophyton floccosum, Trichophyton and Microsporum species, the causative fungi of tinea corporis. To evaluate the efficacy of topical griseofulvin in the treatment of tinea circinata using three different vehicles for drug delivery. Sixteen patients with tinea circinata were instructed to apply either griseofulvin gel form in group A or a similar placebo gel for control group; a niosomal gel formulation of griseofulvin for group B or; a liposomal gel formulation of griseofulvin for group C. Patients were evaluated both clinically and mycologically after 3 weeks. Marked improvement was seen for groups A, B and C both clinically and mycologically while no improvement was observed in the placebo group. Mild and transient irritation was reported in four patients. Our results show that topical griseofulvin preparations may be effective and safe in treating tinea circinata and that further large-scale studies may establish the high efficacy of the niosomal gel formulation. [source]

A Novel Gel Formulation of 0.25% Tretinoin and 1.2% Clindamycin Phosphate: Efficacy in Acne Vulgaris Patients Aged 12 to 18 Years

Antimicrobial and antioxidant activities of traditional Thai herbal remedies for aphthous ulcers

PHYTOTHERAPY RESEARCH, Issue 10 2010
Chantana Mekseepralard
Abstract Four medicinal plants (Quercus infectoria, Kaempferia galanga, Coptis chinensis and Glycyrrhiza uralensis) as well as one traditional Thai treatment for aphthous ulcers based on these four plants were tested for antimicrobial activity. MIC values for a range of bacteria and Candida albicans were determined, with both type strains and clinical isolates being used. Antioxidant activity was determined using the ABTS radical scavenging assay. Among the four plants, Q. infectoria showed antimicrobial activity against Staphylococcus aureus with an MIC of 0.41,mg/mL, while C. chinensis showed antifungal activity against C. albicans with an MIC of 6.25,mg/mL. Activity was also shown against a range of other organisms including Salmonella typhi, Serratia marcescens, Vibrio cholerae, Vibrio parahaemolyticus, Pseudomonas aeruginosa and Enterococcus faecalis. The antimicrobial activity of the traditional aphthous ulcer preparation (a powder) was comparable to that for the individual plant extracts, however, incorporation of the powder into a gel formulation resulted in the loss of almost all activity. All extracts, with the exception of K. galanga, also showed good antioxidant activity. This study supports the traditional use of these plants and suggests that they may also be useful in the treatment of other infections. Copyright © 2010 John Wiley & Sons, Ltd. [source]

Antiallergic and antihistaminic effect of two extracts of Capparis spinosa L. flowering buds

PHYTOTHERAPY RESEARCH, Issue 1 2005
Domenico Trombetta
Abstract The antiallergic properties of two lyophilized extracts obtained from Capparis spinosa L. flowering buds (capers) by methanol extraction, carried out at room temperature (CAP-C) or with heating at 60 °C (CAP-H), were investigated. The protective effects of CAP-H and CAP-C, orally administered (14.28 mg[sol ]kg), were evaluated against Oleaceae antigen challenge-induced and histamine-induced bronchospasm in anaesthetized guinea-pigs. Furthermore, the histamine skin prick test was performed on humans, applying a gel formulation containing 2% CAP-C (the only extract able to protect against histamine-induced bronchospasm) on the skin for 1 h before histamine application and monitoring the erythema by reflectance spectrophotometry. The CAP-H showed a good protective effect against the bronchospasm induced by antigen challenge in sensitized guinea-pigs; conversely, a significant decrease in the responsiveness to histamine was seen only in CAP-C pretreated animals. Finally, the CAP-C gel formulation possessed a marked inhibitory effect (46.07%) against histamine-induced skin erythema. These two caper extracts displayed marked antiallergic effectiveness; however, the protective effect of CAP-H was very likely due to an indirect mechanism (for example, inhibition of mediator release from mast cells or production of arachidonic acid metabolites); conversely, CAP-C is endowed with direct antihistaminic properties. The different mechanisms of action of CAP-H and CAP-C may be related to a difference in the extraction procedure and, thus, in their qualitative[sol ]quantitative chemical profile. Copyright © 2005 John Wiley & Sons, Ltd. [source]

Effect on absorption and oxidative stress of different oral Coenzyme Q10 dosages and intake strategy in healthy men

BIOFACTORS, Issue 1-4 2005
R. B. Singh
Abstract Introduction: The effect of various dosages and dose strategies of oral coenzyme Q10 (Q10) administration on serum Q10 concentration and bioequivalence of various formulations are not fully known. Subjects and Methods: In a randomized, double blind, placebo controlled trial 60 healthy men, aged 18,55 years, were supplemented with various dosages and dose strategies of coenzyme Q10 soft oil capsules (Myoqinon 100 mg, Pharma Nord, Denmark) or crystalline 100 mg Q10 powder capsules or placebo. After 20 days blood levels were compared and oxidative load parameters, malondialdehyde (MDA) and thiobarbituric acid reactive substances (TBARS) were monitored to evaluate bioequivalence. All the subjects were advised to take the capsules with meals. Blood samples were collected after 12 hours of overnight fasting at baseline and after 20 days of Q10 administration. Compliance was evaluated by counting the number of capsules returned by the subjects after the trial. Results: Compliance by capsule counting was >90%. Side effects were negligible. Serum concentrations of Q10 (average for groups) increased significantly 3,10 fold in the intervention groups compared with the placebo group. Serum response was improved with a divided dose strategy. TBARS and MDA were in the normal ranges at baseline. After 20 days intervention in the 200 mg group TBARS and MDA decreased, but the decrease was only significant for MDA (Fig. 2). Conclusions: All supplementations increased serum levels of Q10. Q10 dissolved in an oil matrix was more effective than the same amount of crystalline Q10 in raising Q10 serum levels. 200 mg of oil/soft gel formulation of Q10 caused a larger increase in Q10 serum levels than did 100 mg. Divided dosages (2 × 100 mg) of Q10 caused a larger increase in serum levels of Q10 than a single dose of 200 mg. Supplementation was associated with decreased oxidative stress as measured by MDA-levels. Indians appear to have low baseline serum coenzyme Q10 levels which may be due to vegetarian diets. Further studies in larger number of subjects would be necessary to confirm our findings. [source]

Transdermal delivery system for zidovudine: in vitro, ex vivo and in vivo evaluation

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 1 2004
Sunil Thomas Kumar Narishetty
Abstract The objective of this study was to prepare a transdermal delivery system (TDS) for zidovudine (AZT) with a combination of menthol and oleic acid as penetration enhancers incorporated in hydroxypropyl methylcellulose, and to evaluate ex vivo as well as in vivo permeation across rat skin. It was found that AZT in gel formulation was stable in both refrigerated as well as accelerated stability conditions for 3 months and further, the gel did not significantly retard the permeability of AZT across the skin in comparison with solution formulation. Ex vivo steady state flux of AZT across rat skin from gel was 2.26 mg cm,2 h,1, which is sufficient to achieve therapeutic plasma concentrations. Intravenous pharmacokinetic parameters of AZT in rats were determined and used together with ex vivo flux data to generate theoretical plasma profiles of AZT and compared with plasma concentrations achieved after application of TDS. Further, steady state plasma concentrations of drug following multiple applications of TDS were determined and good correlations between ex vivo and in vivo data were observed. In addition, the combination of penetration enhancers used at 2.5% w/w in this study proved efficient in achieving sufficient enhancement in the transdermal permeability of AZT across rat skin with reduced skin irritation potential when compared with individual penetration enhancers at higher concentrations. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, TestimÔ, compared to AndroGel®

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 3 2003
T. Marbury
Abstract A two-period, randomized, complete crossover study was performed to evaluate the pharmacokinetic profiles of TestimÔ (AA2500), a new 1% testosterone topical gel formulation, compared to AndroGel®, an already available 1% testosterone topical gel. Twenty-nine hypogonadal subjects received a single dose (50 mg testosterone) of each formulation seven days apart. Cmax estimates for total testosterone, dihydrotestosterone and free testosterone were greater (30, 19 and 38%, respectively) following the application of TestimÔ compared to AndroGel®. Similarly, AUC0,24 estimates for total testosterone, dihydrotestosterone, and free testosterone were greater (30, 11 and 47%, respectively) following the application of TestimÔ compared to AndroGel®. Confidence intervals for Cmax and AUC0,24 were not wholly contained within the bioequivalence limits for testosterone, therefore TestimÔ and AndroGel® are not bioequivalent with TestimÔ providing higher serum levels and greater bioavailability than AndroGel®. Copyright © 2003 John Wiley & Sons, Ltd. [source]

A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function

BJU INTERNATIONAL, Issue 4 2003
A.R.E. Blacklock, FRCS Ed
No abstract is available for this article. [source]