A comparative physicochemical and pharmacological evaluation of dexamethasone sodium phosphate and betamethasone sodium phosphate mucoadhesive gels for the treatment of oral submucous fibrosis in rats

Abstract The present study is aimed to formulate steroidal oral mucoadhesive gels of dexamethasone sodium phosphate and betamethasone sodium phosphate. Six gel formulations each of dexamethasone sodium phosphate and betamethasone sodium phosphate prepared using two different polymers carboxymethyl cellulose sodium and hydroxypropyl methylcellulose, in variable proportions. All the formulations subjected for assessment of various physicochemical parameters and mechanical properties. The formulations BSP5 and DSP5, both containing 1.25 % carboxymethyl cellulose sodium, 1.25 % hydroxypropyl methylcellulose, exhibiting mucoadhesive strength of 12.300 ± 0.004 and 12.600 ± 0.01, adhesiveness of 28.04 ± 00 and 30.02 ± 00, cohesiveness of 28.04 ± 00 and 30.02 ± 00, drug release of 86.869 ± 0.380 % and 88.473 ± 0.457 % respectively were considered as promising ones and were further subjected for stability studies and in vivo study in male albino rats. Formulation DSP5 upon oral application for 4 months in arecoline induced oral submucous fibrosis rats, showed more than 80 % reduction in fibrosis as compared with BSP5 which showed nearly 50 % reduction. These results were concluded on the basis of histopathological profile and weight gain among the experimental animals during in vivo study. Hence, DSP5 by minimizing the painful injuries and morbidities justifies being suitable noninvasive model for OSMF treatment.

Two Cases of Stevens-Johnson Syndrome Caused by Systemic Corticosteroids / 대한피부과학회지

Stevens-Johnson syndrome (SJS) is a fatal, acute, hypersensitivity reaction which is associated with certain drugs. The disease has often been managed by systemic corticosteroids. However, there have been a few reports of SJS caused by systemic corticosteroids in Western countries. We herein present two cases of SJS related to deflazacort and betamethasone sodium phosphate. It is worth mentioning that corticosteroids might be offending drugs for SJS. Due to the difficulty in predicting a cross-reaction between corticosteroids and also the existence of concomitant allergies to other corticosteroids, we should consider an alternative strategy such as intravenous immunoglobulin-G in patients with SJS caused by systemic corticosteroids.

Determination of 3 Kinds of Residual Organic Solvents in Betamethasone Sodium Phosphate Raw Material by Headspace Capillary Gas Chromatography / 中国药房

OBJECTIVE: To establish headspace capillary gas chromatography for the content determination of 3 kinds of residual organic solvent (furanidine,methanol and ethanol) in betamethasone sodium phosphate raw material.METHODS: The sample was dissolved in water and n-propanol was used as internal standard.The residual solvent in betamethasone sodium phosphate was separated on HP-INNOWAX (PEG) capillary column with column temperature set at 60 ℃.The injector temperature and FID detector temperature were controlled at 180 ℃ and 250 ℃,respectively.The carried gas was nitrogen at flow rate of 1.0 mL?min-1.The splitting-ratio was 10 ∶ 1.The containers of head-space injector were in equilibrium at 80 ℃ for 30 min.Injection time was 1 min.RESULTS: With this chromatographic condition,those solvents could be separated completely.The linear range were 0.014 4～0.071 8 mg?mL-1 for furanidine,0.060～0.300 mg?mL-1 for methanol and 0.099 3～0.497 mg?mL-1 for ethanol.The average recovery were 103.7% (RSD=0.53%,n=6),95.8% (RSD=0.30%,n=6) and 95.0% (RSD=0.48%,n=6) respectively.The minimum quantitation limit were 0.057 3 ?g?mL-1,0.486 ?g?mL-1,0.145 ?g?mL-1,respectively.3 kinds of residual organic solvents were all in line with the standard stated in Chinese Pharmacopeia.CONCLUSION: The established method is simple,sensitive and accurate for the content determination of residual solvents in betamethasone sodium phosphate raw material.