Nasra Maha M A, Khiri Heba M, Hazzah Heba A, Abdallah Ossama Y
a Department of Pharmaceutics , Faculty of Pharmacy, Alexandria University , Alexandria , Egypt and.
b Department of Pharmaceutics , Faculty of Pharmacy and Drug Manufacturing, Pharos university in Alexandria , Alexandria , Egypt.
Drug Deliv. 2017 Nov;24(1):133-142. doi: 10.1080/10717544.2016.1233591.
This study aimed to develop syringeable in-situ curcumin (cur) gel for the treatment of periodontal pockets as well as to evaluate the clinical efficacy of Cur in-situ gel formulation. Different in-situ gel formulations of Cur were prepared using 30% of pluronic F127, and 1% of carbopol P934. The formulations were evaluated regarding gelation temperature, pH, viscosity, syringeability study, in-vitro release and chemical stability of cur. The effect of aging of gel formulations for 3months in refrigerator was investigated. The selected formulation was clinically evaluated through the determination of probing depth, plaque index, and bleeding index at baseline and 1 month after application. The formulations showed accepted gelation temperature ranging from 28 to 34 °C and all had pH value of 4. The viscosity of the formulations at 4 °C ranged from 19 000 to 37 000 cP. All formulations were easily syringeable through 21 gauge needle at cold temperature. Curcumin stability during the release study was maintained. Aging showed no significant effect on release profile, drug content, or the pH after 3 months, while it showed a slight increase in viscosity with concomitant decrease in gelation temperature. Selected formulations delivered into periodontal pocket evaluated clinically showed to be effective. The treated group revealed that the adjunctive use of intracrevicular 2% curcumin in-situ gel adjunct to mechanical treatment in patients with adult periodontitis could aid in significant clinical reduction of probing depth, bleeding index, and to less extent of plaque. This indicates that curcumin in this novel drug delivery system is an excellent candidate for periodontal disease treatment.
本研究旨在开发用于治疗牙周袋的可注射原位姜黄素（Cur）凝胶，并评估Cur原位凝胶制剂的临床疗效。使用30%的泊洛沙姆F127和1%的卡波姆P934制备了不同的Cur原位凝胶制剂。对制剂的胶凝温度、pH值、粘度、可注射性、体外释放和Cur的化学稳定性进行了评估。研究了凝胶制剂在冰箱中老化3个月的影响。通过在基线和应用后1个月测定探诊深度、菌斑指数和出血指数，对所选制剂进行临床评估。制剂的胶凝温度在28至34°C之间，可接受，所有制剂的pH值均为4。制剂在4°C时的粘度在19000至37000 cP之间。所有制剂在低温下均可轻松通过21号针头注射。在释放研究过程中姜黄素的稳定性得以保持。老化对3个月后的释放曲线、药物含量或pH值没有显著影响，但显示粘度略有增加，同时胶凝温度降低。临床评估显示，注入牙周袋的所选制剂有效。治疗组表明，在成人牙周炎患者中，在机械治疗的基础上辅助使用龈沟内2%姜黄素原位凝胶可显著降低临床探诊深度、出血指数，并在一定程度上减少菌斑。这表明这种新型药物递送系统中的姜黄素是治疗牙周疾病的极佳候选药物。
