Reengineering of a commercially available bovine intravaginal insert (CIDR insert) containing progesterone
Autor: | Michael J. Rathbone, Shane Burggraaf, Christopher R. Burke, K.L. Macmillan, Kim L. Pickering, Craig R. Bunt, Colin Roger Ogle |
---|---|
Rok vydání: | 2002 |
Předmět: |
Active ingredient
medicine.medical_specialty Vaginal route Materials science Chemistry Pharmaceutical Biomedical Engineering Pharmaceutical Science Controlled release Dosage form Insert (molecular biology) Surgery Administration Intravaginal chemistry.chemical_compound Silicone Pharmaceutical technology chemistry medicine Animals Cattle Female Drug carrier Progesterone Biomedical engineering |
Zdroj: | Journal of Controlled Release. 85:105-115 |
ISSN: | 0168-3659 |
DOI: | 10.1016/s0168-3659(02)00288-2 |
Popis: | The purpose of this study was to reengineer a commercially available intravaginal insert containing 1.9 g progesterone (CIDR intravaginal insert) for a 7-day insertion period in cattle. The reengineering process resulted in a reduced initial drug load (1.38 g) and a reduction in the residual drug load following insertion, while at the same time maintaining the biological performance of the insert. The in vitro and in vivo pharmaceutical properties of the commercially available CIDR intravaginal insert were characterized initially to gain a thorough understanding of the factors that affected progesterone release from the insert. The effect of changing a selection of formulation and physical variables of the insert was also investigated (including surface area, drug load, addition of pore forming materials, silicone shore hardness and drug particle size). The knowledge gained from these studies was used to define the characteristics of the reengineered insert which was then manufactured and shown to be bioequivalent and clinically equivalent to the commercially available insert. |
Databáze: | OpenAIRE |
Externí odkaz: |