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Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes
المؤلفون المشاركون
Dangre, Pankaj V.
Phad, Ram D.
Chalikwar, Shailesh S.
Surana, Sanjay J.
المصدر
Advances in Polymer Technology
العدد
المجلد 2019، العدد 2019 (31 ديسمبر/كانون الأول 2019)، ص ص. 1-13، 13ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2019-05-05
دولة النشر
مصر
عدد الصفحات
13
التخصصات الرئيسية
الملخص EN
The present work endeavors fabrication of fast dissolving buccal film of clonidine hydrochloride by employing quality by design (QbD) based approach.
The total nine formulations were prepared according to formulation by design helped by JMP software 13.2.1.
The patient oriented quality target product profiles were earmarked and on that basis critical quality attributes were identified.
Preliminary screening studies along with initial risk assessment eased the selection of film-forming polymer (HPMC E 15) and plasticizer (PEG 400) as CMAs for formulation of films.
A 32 full factorial plan was utilized for assurance of impact, i.e., HPMC E15 (X1) and PEG 400 (X2), as independent variables (factors) on thickness (mm) (Y1), disintegration time (s) (Y2), folding endurance (Y3), and tensile strength (kg) (Y4).
Furthermore, prediction profiler assists in predicting composition of best formulation encompassing desired targeted response.
The optimized formulation (F6) showed fast drug dissolution (>90%) within 8 min, and solid state characterization by DSC, XRD revealed excellent film characteristics.
In a nutshell, the fast dissolving buccal film for clonidine hydrochloride was successfully developed assisted by QbD approach with markedly improved biopharmaceutical performance as well as patient compliance.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Dangre, Pankaj V.& Phad, Ram D.& Surana, Sanjay J.& Chalikwar, Shailesh S.. 2019. Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes. Advances in Polymer Technology،Vol. 2019, no. 2019, pp.1-13.
https://search.emarefa.net/detail/BIM-1121938
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Dangre, Pankaj V.…[et al.]. Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes. Advances in Polymer Technology No. 2019 (2019), pp.1-13.
https://search.emarefa.net/detail/BIM-1121938
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Dangre, Pankaj V.& Phad, Ram D.& Surana, Sanjay J.& Chalikwar, Shailesh S.. Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes. Advances in Polymer Technology. 2019. Vol. 2019, no. 2019, pp.1-13.
https://search.emarefa.net/detail/BIM-1121938
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1121938
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر
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