Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmace...Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.展开更多
Introduction:Acrodermatitis continua of Hallopeau(ACH)is an uncommon chronic cutaneous disorder.Up to date,its treatment is still difficult and frustrating although various topical and systemic agents alone or in diff...Introduction:Acrodermatitis continua of Hallopeau(ACH)is an uncommon chronic cutaneous disorder.Up to date,its treatment is still difficult and frustrating although various topical and systemic agents alone or in different combinations have been tried with variable benefits.Herein,we report two cases of ACH successfully treated with calcipotriol/betamethasone ointment.Case presentation:Two cases of ACH were characterized by thumb involvement alone and showed an excellent response to calcipotriol/betamethasone ointment(1 g:calcipotriol 50µg and betamethasone 0.5 mg).Discussion:Treatment of ACH is challenging for physicians.Multiple systemic therapies and topical drugs have been applied,however,no universally effective treatment regimen has yet been established for long-lasting remission.Combination of calcipotriol and betamethasone is more effective in treating psoriasis than the individual components alone,and the current 2 cases with ACH were reported to be treated successfully by the calcipotriol/betamethasone ointment.Conclusion:Topical calcipotriol/betamethasone compound is an optional agent for the treatment of ACH with a novel effect.展开更多
文摘Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.
文摘Introduction:Acrodermatitis continua of Hallopeau(ACH)is an uncommon chronic cutaneous disorder.Up to date,its treatment is still difficult and frustrating although various topical and systemic agents alone or in different combinations have been tried with variable benefits.Herein,we report two cases of ACH successfully treated with calcipotriol/betamethasone ointment.Case presentation:Two cases of ACH were characterized by thumb involvement alone and showed an excellent response to calcipotriol/betamethasone ointment(1 g:calcipotriol 50µg and betamethasone 0.5 mg).Discussion:Treatment of ACH is challenging for physicians.Multiple systemic therapies and topical drugs have been applied,however,no universally effective treatment regimen has yet been established for long-lasting remission.Combination of calcipotriol and betamethasone is more effective in treating psoriasis than the individual components alone,and the current 2 cases with ACH were reported to be treated successfully by the calcipotriol/betamethasone ointment.Conclusion:Topical calcipotriol/betamethasone compound is an optional agent for the treatment of ACH with a novel effect.
