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Progesterone-loaded poly(lactic) acid fibrous polymeric patches were produced using electrospinning and pressurized gyration for intra-vaginal application to prevent preterm birth. The patches were intravaginally inserted into rats in the final week of their pregnancy, equivalent to the third trimester of human pregnancy. Maintenance tocolysis with progesterone-loaded patches was elucidated by recording the contractile response of uterine smooth muscle to noradrenaline in pregnant rats. Both progesterone-loaded patches indicated similar results from release and thermal studies, however, patches obtained by electrospinning had smaller average diameters and more uniform dispersion compared to pressurized gyration. Patches obtained by pressurized gyration had better results in production yield and tensile strength than electrospinning; thereby pressurized gyration is better suited for scaled-up production. The patches did not affect cell attachment, viability, and proliferation on Vero cells negatively. Consequently, progesterone-loaded patches are a novel and successful treatment strategy for preventing preterm birth.

Compromised stability of pharmaceutical formulations loaded with volatiles is a serious problem associated with devices designed to deliver volatile compounds. The present study has been focused to evaluate the stability potential of matrix-type polymeric patches composed of volatile ethyl anthranilate for prophylaxis against vector-borne diseases. Ethyl anthranilate-loaded matrix-type polymeric patches were fabricated by solvent evaporation method on an impermeable backing membrane and attached to temporary release liners. Stability testing of the polymeric patches was performed as per the International Conference on Harmonization (ICH) guidelines for 6 months under accelerated conditions. In addition, the quantification of residual solvents was also performed as per the ICH guidelines. After conducting the stability studies for 6 months, the optimized patches showed the best possible results with respect to uniformity of drug content, physical appearance, and other analytical parameters. Furthermore, the amount of residual solvent was found well below the accepted limit. Thus, the present report outlined the analytical parameters to be evaluated to ensure the stability of a certain devices consisting of volatile compounds.

It is the patient compliance and stability in combination with controlled drug delivery and biocompatibility that forms the core feature in present research and development of sustained biodegradable patch formulation intended for wound healing. The aim was to impart sustained degradation, sterile formulation, significant folding endurance, elasticity, biodegradability, bio-acceptability and strength. The optimized formulation comprised of polymers including Hydroxypropyl methyl cellulose, Ethylcellulose, and Gelatin, and Citric Acid PEG Citric acid (CPEGC) triblock dendrimers and active Curcumin. Polymeric mixture dissolved in geometric order in suitable medium through continuous stirring under ambient conditions. With continued stirring Curcumin was added with aid of DCM and Methanol in optimized ratio to get homogenous dispersion. The dispersion was sonicated with optimum frequency and for given time and later casted to form a patch form. All steps were carried out under strict aseptic conditions. The formulations obtained in the acceptable working range were decided based on thickness, uniformity of drug content, smooth texture and flexibility and brittleness. The patch kept on stability using butter paper in sterile pack displayed folding endurance in range of 20 to 23 times without any evidence of crack in an optimized formulation at room temperature (RT) (24 ± 2°C). The patch displayed acceptable parameters after stability study conducted in refrigerated conditions (8±0.2°C) and at RT (24 ± 2°C) up to 90 days. Further, no significant changes were observed in critical parameters such as elasticity, biodegradability, drug release and drug content during stability study conducted at RT 24±2°C for 45 and 90 days. The drug content was in range 95 to 102%, moisture content didn't exceeded 19.2% and patch passed the content uniformity test. Percentage cumulative drug release was found to be 80% in 12h and matched the biodegradation rate as drug release with correlation factor R2>0.9. The biodegradable patch based formulation developed shows promising results in terms of stability and release profiles., {"references":["Koide S.S. \"Chitin-Chitosan: Properties, Benefits and Risks\", Nutrition\nResearch (18), 1998, 1091-1101.","Qi L, Xu Z, Jiang X, Hu C, Zou X. \"Preparation and antibacterial\nactivity of chitosan Nanoparticles\", Carbohydrate Research (339), 2004,\n2693-2700.","Hima Bindu TVL, Vidyavathi M., Kavitha K., Sastry T.P., Suresh\nKumar RV. \"Preparation and Evaluation of Chitosan-Gelatin Composite\nFilms for Wound Healing Activity\", Trends Biomater, Artif. Organs 24,\n2010, 123-130.","Sidhu GS, Mani H, Gaddipatti JP, Singh AK, Seth P, Banaudha KK,\nPatnaik GK, Maheshwari RK. \"Curcumin enhances wound healing in\nstreptozotocin induced diabetic rats and genetically diabetic mice\",\nWound Repair Regen (75), 1999, 362–74.","Durgaprasad S, Reetesh R, Kumar H, Rajput R, \"Effect of a topical\ncurcumin preparation (BIOCURCUMAX) on burn wound healing in\nrats\", Journal of Pharmaceutical and Biomedical Sciences, 2011,8, 23.","Nilani P., Pranavi A., Duraisamy B., Damodaran P., Subhashini V,\nElango K. \"Formulation and evaluation of wound healing dermal patch\"\nAfrican Journal Of Pharmacy and Pharmacology Vol5(9), 2011, 1252-\n1257.","Clark R. \"Basics of cutaneous wound repair\", J. Dermatol. Surg.Oncol:\n19(8), 1993, 693-706.","Leong KW \"Biodegradable polymers as drug delivery systems\" In:\nTarcha PJ, editors, Polymers for controlled drug delivery. CRC Press:\nBoca Raton; 1991, 128.","Karlsson RR, Albertson AC. \"Biodegradable polymers and\nenvironmental interaction\" Polymer Eng. Sci., 38(8), 1998, 1251-1253.\n[10] Namazi, H. and M. Adeli, \"Dendrimers of citric acid and poly (ethylene\nglycol) as the new drug delivery agents\", Biomaterials, 26(10): 2005,\n1175-1183.\n[11] Wadhwa J, Asthana A, Shilakari G., Chopra A.K., Singh R.,\n\"Development and Evaluation of Nanoemulsifying Preconcentrate of\nCurcumin for Colon Delivery\", The Scientific World Journal (Hindawi\nPublishing Corporation), 2015, Article ID 541510, 13 pages\nhttp://dx.doi.org/10.1155/2015/541510.\n[12] Shally T., Asthana A. Formulation and evaluation of biodegradable\nwound healing dermal patch of curcumin. M.M. University, Mullana,\nIndia, 2013."]}