Background and Objectives: Systemic and topical antimicrobials are effective in the treatment of inflammatory acne vulgaris. Widespread use of these agents is increasingly associated with the emergence of resistant pathogens. Thus, it highlights the need for an alternative nonantimicrobial agents for the treatment of acne. Nicotinamide gel provides potent anti-inflammatory activity without the risk of inducing bacterial resistance.Materials and Methods: In this double blind investigation, the safety and efficacy of topically applied 4% Nicotinamide gel was compared to 1% Clindamycin gel for the treatment of 80 patients with moderate to severe inflammatory acne vulgaris. Out of these 80 patients, 30 were males and 50 females. Most of the patients were in 16-20 years age group. Forty patients were treated by 4% nicotinamide gel and other 40 were given 1% clindamycin gel. Patients were unaware of the name of medicine except the code A and B. Thus, a total of 80 patients were randomly assigned to apply either 1% clindamycin gel (N=40, Group A) or 4% nicotinamide gel (N=40, Group B) twice daily for 8 weeks. Efficacy was evaluated after 4 and 8 weeks using a physicians global evaluation, acne lesion count and an acne severity rating. Results: At the start of treatment, for patients under clindamycin or nicotinamide gel therapy, acne severity count median was 5.75 1.45 and 6.1 1.19 respectively. After 4 weeks therapy, acne severity count average for group A reached to 3.4 and for group B to 4.05. After 8 weeks treatment, acne severity count average in the first group reached to 2.05 1.72 and in second group it was 2.05 1.39 and p=1. After 8 weeks, both treatments produced comparable beneficial results in the physicians global evaluation of inflammatory acne.Conclusion: These results demonstrate that 4% nicotinamide gel is more efficient as compared to 1% clindamycin in the treatment of acne vulgaris. Because topical clindamycin like other antimicrobials is associated with emergence of resistant microorganisms, nicotinamide gel is a desirable alternative treatment for acne vulgaris.

Acne vulgaris is a chronic and prevalent usually self-limited disorder. Topical medication is the main route for acne therapy. In this disorder the most widely used topical preparations are antibiotics such as Erythromycin and keratolytic agents such as Tretinoin. Excellent results with minimal side effects may be achieved by a fixed combination of Tretinoin and Erythromycin. This combination therapy increases efficacy and a faster response in the treatment of acne may be achieved. The purpose of this work was to assess a suitable formulation of Erytromycin and Tretinoin in a topical gel base. UV spectrophotometer analysis was chosen for Erythromycin and Tretinoin assay. This method was adapted to assay Erytromycin and Tretinoin in their combination. The proposed method for Erythromycin was the formation of a complex with O-nitrobenzaldehyde, in glacial acetic acid and in the presence of hydrochloric acid, which manifested maximum absorbance at 486nm. For the measurement of Tretinoin, the absorption peak at 355nm in acidic Ethanol-Water-Iso Propyl alcohol (IPA) mixture was suitable. In order to formulate the Tretinoin and Erythromycin in a gel base, gelling agents, plasticizers, solvents, cosolvents such as Carbopol, HPC, HPMC, Ethanol, Propylene Glycol (PG), Isopropyl Alcohol (IPA) and Water have been used. By using tertiary diagrams, the most proportionate percentage of gel constituents have been determined. The formulations have been controlled for rheological, organoleptic properties and physical and chemical stability under several conditions (4, 25, 40˚C). The release of drugs from the gels was studied using Franz diffusion cell and the best formulations were chosen. Drug release rates followed Higuchi's law. The results indicated that Erythromycin and Tretinoin could be formulated in a gel base with a suitable release profile and presented to pharmaceutical market.

Introduction: Dapsone gel (5%) is found to be effective in treating acne. The study was to develop a topical formulation of dapsone in Iran. Objective: Determination of appropriate formulation for generic form of this drug in the treatment of acne. Materials and Methods: Samples of the base of gel were made in the range of 0. 3%-5% by dissolving Carbomer 934P in distilled water, and their physical properties and pH were evaluated. Then, Dapsone was dissolved in its appropriate solvent, diethylene glycol monoethyl ether (DEG) and were introduced into gel base. Afterwards, using Design Expert software 13 samples and in the next step 17 samples were designed, made and their rheological properties and pH were evaluated. Then, two formulations were selected and were characterized by drug content, physicochemical properties, rheology and stability and found to be in accordance with the US Pharmacopeia. Results: The gel bases containing carbomer in the range of 1-3% were appropriate. The pH value of gel bases in first 13 samples were between 5-7 and the viscosity range between 16530-2980000(cp). The viscosity of range of 17 designed samples was between 1100-760000(cp). The final sample with 1% carbomer content had the viscosity range of 14075-268000(cp) and drug release of 78/1% after 3 hours. The sample with 2% carbomer content had the viscosity range of 92660-557000(cp) and drug release of 76% after 3 hours. Conclusion: Viscosity and drug release of both samples were in accordance with pharmacopeia. However, the sample containing 1% carbomer is more commercially suitable and more appropriate lowering pH of the skin.

Introduction & Objective: Because of too sever pain accompanying a hemorrhoidectomy operation; this double blind clinical trial study was done for comparison of post operative analgesia in patients which used preoperative topical lidocaine jel with those that used preoprative lubricant gel.Materials & Methods: Two group 45 patients were candidated for elective hemorrhoidectomy under general anesthesia, and they were randomly divided into two groups, one group received preoperative topical lidocaine jel and second group received preoperative lubricant gel. Then gathered data was analyzed with Chi-square and Mann-Whitney U and T-Student test by SPSS 13 software. The results were evaluated as the mean ± SD and considered statistically significant for P<0.05.Results: The two groups showed similar results for demographic parameters such as age, weight and sex (P>0.05). In the preoperative lidocaine jel group severity of postoperative pain was lower (P<0.05) similarly, the time of free pain period in the preoperative lidocaine jel group was longer (P<0.05).Conclusions: The use of preoperative lidocaine jel in hemorrhoidectomy operation can decrease the severity of pain and can cause longer postoperative free pain period in patients.

Background: The goal of the present study was the preparation and evaluation of griseofulvin topical gel as a drug dosage form with appropriate efficacy and stability. Methods: To select the best formulation, formulations with different concentration of carbomer and HPMC were evaluated for their appearance. Then evaluated for physicochemical characteristics such as rheologic behavior, viscosity, stability and drug release. Results: The result showed that the topical gel of griseofulvin prepared with Carbomer 0.5% and HPMC2.5% had good chemical stability, viscosity and drug release. The evaluation of the kinetic of drug release indicated that the formulations containing Carbomer 0.5% and HPMC 2.5% followed zero order release and liner Wagner, respectively. Rheological data showed that while HPMC gel shows a very mild plastic behavior, Carbomer based gels behave very significantly as a thixotropic pseudo plastic gel. Discussion: Rheological behavior can affect the physicochemical and pharmacological aspects of the drug and plastic behavior of carbomer gel made it suitable for topical application. Although clinical research is necessary for Confirm the effectiveness but as a result, topical griseofulvin in a suitable formulation showed good drug release and efficacy.

Purpose: The objective of this work was to develop a bioadhesive topical gel of sertaconazole nitrate with the help of response-surface approach.Methods: Experiments were performed according to a 3-level factorial design to evaluate the effects of two independent variables [amount of Carbapol 934=X1) and Sodium carboxymethylcellulose (NaCMC) =X2)] on the bioadhesive character of gel, rheological property of gel (consistency index), and in-vitro drug release. The best model was selected to fit the data.Results: Mathematical equation was generated by Design ExpertÒ software for the model which assists in determining the effect of independent variables. Response surface plots were also generated by the software for analyzing effect of the independent variables on the response. The effect of formulation variables on the product characteristics can be easily predicted and precisely interpreted by using a 3-level factorial design and generated quadratic mathematical equations.Conclusion: On the basis of product characteristics viscosity, bioadhesiveness, permeation study, in-vitro release, in-vivo studies, TPA and spreadability it can be concluded that the best batch of topical bioadhesive gel of Sertaconazole nitrate would be with 1% Carbopol 934 and 1% NaCMC.

The objective of this work was to develop bioadhesive topical gel of Aceclofenac with the help of response-surface approach. Experiments were performed according to a 3-level factorial design to evaluate the effects of two independent variables [amount of Poloxamer 407 (PL-407 =X1) and hydroxypropylmethyl cellulose K100 M (HPMC=X2)] on the bioadhesive character of gel, rheological property of gel (consistency index), and in-vitro drug release. The best model was selected to fit the data. Mathematical equation was generated by Design Expert® software for the model which assists in determining the effect of independent variables. Response surface plots were also generated by the software for analyzing effect of the independent variables on the response. Quadratic model was found to be the best for all the responses. Both independent variable (X1 and X2) were found to have synergistic effect on bioadhesion (Y1) but the effect of HPMC was more pronounced than PL-407. Consistency index was enhanced by increasing the level of both independent variables. An antagonistic effect of both independent variables was found on cumulative percentage release of drug in 2 (Y3) and 8 h (Y4). Both independent variables approximately equally contributed the antagonistic effect on Y3 whereas antagonistic effect of HPMC was more pronounced than PL-407.The effect of formulation variables on the product characteristics can be easily predicted and precisely interpreted by using a 3-level factorial experimental design and generated quadratic mathematical equations.

Background: Host modulation therapy represents a treatment concept in which drug therapies are applied as an adjunctive therapy to conventional periodontal treatments to counteract the destructive effects of the host inflammatory response. Methods: This is a randomized split-mouth clinical trial in which a total of 40 outpatients diagnosed with mild-moderate chronic periodontitis with at least two pairs of contralateral anatomically matching proximal tooth surfaces showing probing depth of ≥ 5 mm were enrolled. Full-mouth scaling and root planing (SRP) was performed for all patients and pockets larger than 5 mm were selected for application of the studied gels. The selected sites were randomly divided into group A (piroxicam + metronidazole) and group B (piroxicam). Recall appointments were scheduled every two weeks within 3 months. The periodontal parameters, assessed in the molar teeth, also recorded that changes in clinical parameters during the study. Results: A total of 34 patients, with mean age of 45. 2± 8. 6 (range 32-60) years, none of whom developed unpleasant side effect, were enrolled. Plaque index was significantly higher in group A; further it was a statistically significant difference in Bleeding on probing levels in group A at the baseline to last interval recall while current study. The results exhibited significant reductions in pocket depth within 3 months when compared to the baseline values, while the combination adjunctive therapy was more effective to reduce pocket depth. Furthermore, both groups showed a statistically significant mean reduction in clinical attachment level (CAL), but in the test group A had a higher CAL gain than in the control group B (P=0. 039). Conclusions: The use of a combination of drugs can help reduce the clinical signs of periodontal disease, therefore, by changing the patient’ s health habits along with periodontal treatment, the mechanical treatment that a microbial plaque can be obtained, and then the use of piroxicam + metronidazole gel as a complementary therapy, the recovery process can be accelerated.