Ua hoʻokumu ʻo Joseph Brama i ke kaʻina extrusion no ka hana ʻana i nā paipu alakaʻi i ka hopena o ke kenekulia 18. ʻAʻole hiki i ka waenakonu o ke kenekulia 19 i hoʻomaka ka hoʻohana ʻana i ka ʻenehana extrusion wela wela i ka ʻoihana plastics. Ua hoʻohana mua ʻia i ka hana ʻana i nā uhi polymer insulating no nā uea uila. I kēia lā, hoʻohana nui ʻia ka ʻenehana extrusion wela wela ʻaʻole wale i ka hana ʻana i nā huahana polymer, akā i ka hana ʻana a me ka hui ʻana o nā polymers iā lākou iho. I kēia manawa, ʻoi aku ma mua o ka hapalua o nā huahana plastik, me nā ʻeke plastik, nā ʻili plastik a me nā paipu plastik, i hana ʻia me kēia kaʻina hana.
Ma hope mai, ua puka mālie kēia ʻenehana i loko o ke kahua lāʻau lapaʻau a lilo mālie i ʻenehana pono ʻole. I kēia manawa, hoʻohana ka poʻe i ka ʻenehana hoʻoheheʻe wela e hoʻomākaukau i nā granules, nā papa hoʻokuʻu mau, transdermal a me ka transmucosal lāʻau lapaʻau ʻōnaehana etc. No ke aha i makemake ai nā kānaka i kēia ʻenehana i kēia manawa? ʻO ke kumu ma muli o ka hoʻohālikelike ʻia me ke kaʻina hana kuʻuna i ka wā ma mua, ʻo ka ʻenehana hoʻoheheʻe wela wela nā mea maikaʻi aʻe:
E hoʻomaikaʻi i ka hoʻoheheʻe ʻana o nā lāʻau hoʻoheheʻe maikaʻi ʻole
Loaʻa nā pōmaikaʻi i ka hoʻomākaukau ʻana i nā hoʻopuka hoʻokuʻu hoʻomau
ʻO ka hoʻomākaukau ʻana i nā mea hoʻokuʻu gastrointestinal me ke kūlana pololei
E hoʻomaikaʻi i ka hoʻopili ʻana i ka excipient
Hoʻomaopopo ʻia ke kaʻina hana ʻokiʻoki i hoʻokahi ʻanuʻu
E wehe i kahi ala hou no ka hoʻomākaukau ʻana i nā micropellets
Ma waena o lākou, he kuleana koʻikoʻi ka cellulose ether i kēia kaʻina hana, e nānā kākou i ka hoʻohana ʻana o kā mākou cellulose ether i loko!
Hoʻohana i ka ethyl cellulose
ʻO ka Ethyl cellulose kahi ʻano hydrophobic ether cellulose. I ka lāʻau lapaʻau, ua hoʻohana ʻia ʻo ia i ka microencapsulation o nā mea ikaika, solvent a me extrusion granulation, papa paipu a ma ke ʻano he uhi no ka hoʻokuʻu ʻana i nā papa a me nā beads. Hiki i ka Ethyl cellulose ke hoʻonui i nā kaumaha molekala. ʻO kona mahana hoʻololi aniani he 129-133 degere Celsius, a ʻo kona helu hoʻoheheʻe aniani he emi 180 degere Celsius. He koho maikaʻi ʻo Ethyl cellulose no ka extrusion no ka mea e hōʻike ana i nā waiwai thermoplastic ma luna o kona mahana hoʻololi aniani a ma lalo o kona wela hoʻohaʻahaʻa.
I mea e hoʻohaʻahaʻa i ka mahana hoʻololi aniani o nā polymers, ʻo ke ʻano maʻamau ka hoʻohui ʻana i nā plasticizers, no laila hiki ke hana ʻia i ka haʻahaʻa haʻahaʻa. Hiki i kekahi mau lāʻau lapaʻau ke hana ma ke ʻano he plasticizer iā lākou iho, no laila ʻaʻohe pono e hoʻohui hou i nā plasticizer i ka wā o ke kaʻina hana lāʻau. No ka laʻana, ua ʻike ʻia ʻo nā kiʻiʻoniʻoni i hoʻokuʻu ʻia me ka ibuprofen a me ka ethyl cellulose he haʻahaʻa haʻahaʻa o ke aniani hoʻololi ʻana ma mua o nā kiʻiʻoniʻoni i loaʻa i ka ethyl cellulose wale nō. Hiki ke hana ʻia kēia mau kiʻiʻoniʻoni i loko o ke keʻena hana me nā extruders twin-screw co-rotating. Hoʻopili ka poʻe noiʻi iā ia i loko o ka pauka a laila hana i ka nānā wela. Ua ʻike ʻia ʻo ka hoʻonui ʻana i ka nui o ka ibuprofen hiki ke hoʻohaʻahaʻa i ka mahana hoʻololi aniani.
ʻO kekahi hoʻokolohua ʻo ia ka hoʻohui ʻana i nā mea kōkua hydrophilic, hypromellose, a me ka xanthan gum i ka ethylcellulose a me ka ibuprofen micromatrices. Ua hoʻoholo ʻia ʻo ka micromatrix i hana ʻia e ka ʻenehana hoʻoheheʻe wela wela i ʻoi aku ka maʻamau o ka hoʻohana ʻana i ka lāʻau lapaʻau ma mua o nā huahana i loaʻa i ke kālepa. Ua hana nā mea noiʻi i ka micromatrix me ka hoʻohana ʻana i kahi hoʻonohonoho hoʻonohonoho co-rotating laboratory a me kahi extruder twin-screw me kahi make cylindrical 3-mm. ʻO 2 mm ka lōʻihi o nā pepa extruded ʻoki lima.
Hoʻohana ʻia ʻo Hypromellose
ʻO ka Hydroxypropyl methylcellulose he hydrophilic cellulose ether e pehu ana i loko o kahi hopena colloidal māmā a ʻeleʻele paha i loko o ka wai anuanu. Loaʻa i ka hoʻonā wai i ka hana ʻili, ke ʻike kiʻekiʻe a me ka hana paʻa. ʻokoʻa ka solubility me ka viscosity. ʻO ka haʻahaʻa o ka viscosity, ʻoi aku ka nui o ka solubility. ʻOkoʻa nā waiwai o ka hydroxypropyl methylcellulose me nā kikoʻī like ʻole, a ʻaʻole pili kona hoʻoheheʻe ʻana i ka wai e ka waiwai pH.
I loko o ka lāʻau lapaʻau, ua hoʻohana pinepine ʻia i loko o ka matrix hoʻokuʻu ʻia, ka hoʻopili ʻana i ka papa ʻaina, granulation adhesive, etc. ʻO ka mahana hoʻololi aniani o ka hydroxypropyl methylcellulose he 160-210 degere Celsius, ʻo ia hoʻi inā hilinaʻi ia i nā mea pani ʻē aʻe, ʻo kona wela degradation. ʻoi aku ma mua o 250 degere Celsius. Ma muli o kona kiʻekiʻe aniani hoʻololi wela a me ka haʻahaʻa degradation wela, ka mea, ʻaʻole i hoʻohana nui ʻia i ka ʻenehana extrusion hoʻoheheʻe wela. I mea e hoʻonui ai i kona laulā o ka hoʻohana ʻana, ʻo ke ʻano hoʻokahi wale nō e hui pū i ka nui o ka plasticizer i ke kaʻina hana e like me ka ʻōlelo ʻana a nā loea ʻelua, a hoʻohana i kahi extrusion matrix formulation nona ke kaumaha o ka plasticizer ma kahi o 30%.
Hiki ke hoʻohuiʻia ka Ethylcellulose a me ka hydroxypropylmethylcellulose i kahi ala kūikawā i ka laweʻana i nā lāʻau. ʻO kekahi o kēia mau ʻano hana ʻo ia ka hoʻohana ʻana i ka ethylcellulose ma ke ʻano he paipu waho, a laila hoʻomākaukau i kahi hypromellose grade A ma kahi kaʻawale. Ke kumu cellulose kumu.
Hoʻokumu ʻia ka paipu ethylcellulose me ka hoʻohana ʻana i ka extrusion wela i loko o kahi mīkini hui pū i loko o ka hale hana e hoʻokomo ana i kahi pahu make apo metala, ʻo ke kumu o ia mea i hana lima ʻia ma ka hoʻomehana ʻana i ka hui a hiki i ka heheʻe, a ukali ʻia e ka homogenization. Hoʻokomo lima ʻia ka mea kumu i loko o ka pipeline. ʻO ke kumu o kēia haʻawina ʻo ia ka hoʻopau ʻana i ka hopena o ka popping i kekahi manawa i loko o nā papa matrix hydroxypropyl methylcellulose matrix. ʻAʻole ʻike ka poʻe noiʻi i ka ʻokoʻa o ka hoʻokuʻu ʻana no ka hydroxypropyl methylcellulose o ka like viscosity, akā naʻe, ua hoʻololi ʻia ka hydroxypropyl methylcellulose me ka methylcellulose i hopena i ka wikiwiki hoʻokuʻu.
Outlook
ʻOiai ʻo ka hoʻoheheʻe wela wela he ʻenehana hou i ka ʻoihana lāʻau lapaʻau, ua huki nui ʻia a hoʻohana ʻia e hoʻomaikaʻi i ka hana ʻana o nā ʻano ʻano like ʻole a me nā ʻōnaehana. Ua lilo ka ʻenehana hoʻoheheʻe wela wela i ka ʻenehana alakaʻi no ka hoʻomākaukau ʻana i ka dispersion paʻa i waho. No ka mea ua like kona mau loina ʻenehana me nā ʻano hoʻomākaukau he nui, a ua hoʻohana ʻia i nā ʻoihana ʻē aʻe no nā makahiki he nui a hōʻiliʻili i ka ʻike he nui, he mau manaʻo hoʻomohala ākea. Me ka hohonu o ka noiʻi ʻana, manaʻo ʻia e hoʻonui hou ʻia kāna noi. I ka manawa like, ʻoi aku ka liʻiliʻi o ka ʻenehana extrusion wela wela me nā lāʻau lapaʻau a me kahi kiʻekiʻe o ka automation. Ma hope o ka hoʻololi ʻana i ka ʻoihana lāʻau lapaʻau, manaʻoʻiʻo ʻia e wikiwiki ana kāna hoʻololi GMP.
Ka manawa hoʻouna: Dec-16-2022