جستجوی مقالات مرتبط با کلیدواژه « stability study » در نشریات گروه « پزشکی »

Oral mucositis is a common debilitating complication of cancer chemotherapy and radiotherapy that can reduce the quality of patient’s lives. Hence, treating this condition plays an important role in increasing the patient’s tolerance.

Doxepin mucoadhesive gel is useful for treating oral mucosa inflammation caused by long-term effects of chemotherapy, which has low adverse effects.

Doxepin gel’s formulation was prepared with various concentrations of poloxamer 407 and hydroxypropyl methylcellulose in deionized water. The prepared gels were evaluated for pH, appearance, viscosity, spreadability, stability, and drug release.

After providing gels containing doxepin, formulations 1, 2, 8, and 9 had low quality and, thus, were removed from the study. Based on qualitative evaluations, formulations 3 and 4 did not meet the criteria for mucoadhesive gel and were removed from the study. The best formulation contained 17% w/w poloxamer 407, 10% w/w hydroxypropyl methylcellulose, and 5% w/w doxepin.

Suitable physicochemical properties of prepared doxepin mucoadhesive gel enable it to well cover inflamed and damaged oral mucosa. On the other hand, doxepin’s slow release from formulation (8 hours) can increase therapeutic effects and reduce side effects, which can heal and soothe inflammations of the oral mucosa and be useful in cancer patient’s treatment.

In recent years, due to the eradication of type 2 poliovirus, a bivalent vaccine containing types 1 and 3 is used in Iran. Since it is a highly thermolabile vaccine, it should be stored at a recommended temperature. Since cold chain may not be applied in Iran’s tropical weather conditions, potency of the vaccine may be subjected to change. Therefore, we evaluated the effective factors on the potency of this vaccine.

We evaluated stability of a bivalent oral poliovirus vaccine produced by Razi Institute of Iran to ensure consistency of virus at different temperatures (-20, 2-8, 22-25 and 35-37 ºC), time intervals and freeze/thaw cycles. Three consecutive batches produced during full-scale production were randomly sampled.

At -20 o C, there was no change in vaccine vial monitor (VVM). The potency of the samples exposed to 2-8 o C for 60 days and to 22-25 o C for five days met the specification. The mean potency of the samples was 6.17, 6.00, 5.83, 5.75 and 5.54 (log CCID50/dose) after 10, 20, 30, 40 and 50 freeze/thaw cycles, respectively. In addition, the mean degradation of VVM was 0, 23.33, 60 and 100% for samples exposed to -20, 2-8, 22-25 and 35-37 o C, respectively.

The results indicate the effects of environmental factors on the potency of the vaccines and the correlation between the VVM grade, color change and the vaccine potency for programming vaccine distribution networks at different transit levels. Based on the results of our study, the best temperature for maintenance and transportation of bivalent oral poliovirus vaccine is -20 o C. Furthermore, freeze/thaw cycles lower the potency of the vaccine and change the VVM grade significantly.

Benign prostatic hyperplasia (BPH) is the most common condition in aging men, associated with lower urinary tract symptoms. It is caused due to the augmented levels of the androgen dihydrotestosterone. Dutasteride, a 5α-Reductase inhibitor has been recommended for the treatment of BPH upon oral administration. However, long term oral administration of dutasteride may cause sexual problem in man. Therefore the main objective of this study was to develop transdermal patch having nanoemulsion gel of dutasteride in order to enhance physical and chemical stability and eliminate adverse effect of dutasteride. Optimized nanoemulsion was prepared by aqueous phase-titration method and characterized by droplet size, viscosity and refractive index. In vitro skin permeation of dutasteride through rat abdominal skin was determined by the Franz diffusion cell. Significant increase in the steady state flux (Jss), permeability coefficient (Kp) and enhancement ratio (Er) was observed in optimized nanoemulsion formulation A1 (p < 0.05). The Er of optimized nanoemulsion A1 was found to be 1.52 times with respect to control which indicates transdermal delivery may be better approach for BPH. Stability studies were performed for the period of 3 months. It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period. However, the changes in these parameters were not statistically significant (p ≥ 0.05). The shelf-life of optimized nanoemulsion A1 was found to be 2.18 years at room temperature. These results indicated that both physical as well as chemical stability of dutasteride in nanoemulsion formulation.

In modern clinical practice, combination fixed - dose tablets have become a baseline for effective therapy in many clinical conditions. The Hydrochlorothiazide (Hctz) (12.5mg) / Lisinopril (Lis) (10 mg) tablet is a combination drug for treatment of hypertension. In this study, the tablets were prepared by wet granulation method and characterized in terms of weight variation, hardness, friability, disintegration time, dissolution and stability. A high-performance liquid-chromatographic method (HPLC) was used to assay Hctz and Lis in the prepared tablets. Amongst different formulations, WG14 was found to be the best for product development based on both physicochemical and stability results. Pharmaceutical characteristics of the tablets were compared with the Innovator tablet 1A-Pharma (Germany).

N,N-Diethyl meta Toluamide (DEET) is an insect repellent agent that contrary to its benefits, if is used in formulations with high skin permeation, will produce side effects of different severity. This study attempted to achieve a semi-solid DEET containing formulation with good appearance, sufficient spreadity, suitable viscosity for tube and jar filling, compatible pH with skin, reasonable stability, longer release time, and the less skin permeation. To obtain such a formulation, three types of DEET containing semi solids including gels (hydrophile), creams (emulsion) and ointments (lipophile), and their characteristics were compared with each other and with Off! Brand. Results showed that one of the prepared creams with the proper viscosity, stability, appearance and spreadity, had the least drug release in six hours and less skin permeation of DEET as compared with Off!. Hence the preparation was introduced as the optimal formulation.