Polymeric matrix system for prolonged delivery of tramadol hydrochloride, part II: biological evaluation.
This study is an extrapolation of our previous one (part I) concerned with the formulation and physicochemical evaluation of a novel, simple, monolayer, easy-to-use, cost-effective, and aesthetically acceptable bioadhesive transdermal patch for tramadol hydrochloride. The current work is focused on bioadhesion, skin tolerability, and pharmacodynamic evaluation. Using naked rat skin, chitosan-Eudragit NE30D (1:1) film attained best bioadhesive properties. During in vivo studies, it also showed a significantly extended analgesic effect compared to both oral formula and chitosan single polymeric film using the hot plate test method. All the polymeric films were skin tolerable for the intended period of application according to the Draize test. The success of our approach can proudly, positively contribute into the world of pain management and arguably push transdermal delivery to realize its great promise.
Ammar
Hussein O
HO
Department of Pharmaceutical Technology, National Research Center, Dokki, Cairo, Egypt. husseinammar@hotmail.com
Ghorab
Mahmoud
M
El-Nahhas
Soheir A
SA
Kamel
Rabab
R
D000268:Adhesiveness; D000279:Administration, Cutaneous; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000737:chemistry / Q000494:pharmacology; D000818:Animals; D002626:Chemistry, Pharmaceutical; D048271:Chitosan; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D016503:Drug Delivery Systems; D007509:Irritants / Q000633:toxicity; D008297:Male; D051379:Mice; D010147:Pain Measurement / Q000187:drug effects; D011108:Polymers; D011109:Polymethacrylic Acids; D051381:Rats; D017208:Rats, Wistar; D012867:Skin / Q000737:chemistry / Q000166:cytology; D014147:Tramadol / Q000008:administration & dosage* / Q000737:chemistry / Q000494:pharmacology
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D007509:Irritants; D011108:Polymers; D011109:Polymethacrylic Acids; C038300:methylmethacrylate-methacrylic acid copolymer; D014147:Tramadol; D048271:Chitosan