Ubumenyi bwa Pin-Holes: Nigute wakwemeza ko zeru zeru zinjira muri farumasi yimiti

Ku bayobozi bakuru ba tekinike, abayobozi bashinzwe amasoko ku isi, hamwe n’abayobozi bashinzwe ubuziranenge mu nganda z’imiti, kubungabunga imbaraga n’umutekano w’ibikoresho bikoreshwa mu bya farumasi (APIs) ni ngombwa rwose. Ifishi ikomeye yo mu kanwa - nk'ibinini byangiza ubushyuhe, capsules, na lyofilisate - birashobora kwanduzwa cyane na hydrolytike iyo ihuye n'ubushyuhe bwo mu kirere.

Mugihe aluminiyumu ari inzitizi rwose kuri gaze, urumuri, nubushuhe, inenge ya microscopique ikora izwi nka pinholes irashobora guhungabanya ubunyangamugayo. Gusobanukirwa na metallurgie inyuma yo gushiraho pinhole no gushyira mubikorwa ubugenzuzi bukomeye bwo kugenzura ni ngombwa kugirango umuntu agere kuri zeru zeru (Zero WVTR) mubipfunyika bwa farumasi.

Ingaruka Zikomeye zo Kwinjira Mubushuhe mubikoresho bya farumasi

Ibiyobyabwenge bigezweho bishingiye kumiterere yimiti myinshi mumyaka myinshi. Ubushuhe bwa Atmospheric ni kimwe mu bitera ubukana bwo kwangiza ibiyobyabwenge.

Intege nke Zibikoresho bya farumasi bifatika (APIs) kubushuhe

Iyo ubuhehere bwinjiye mu cyuho cya blister, bukora hamwe na APIs zoroshye hamwe na hygroscopique. Ubushuhe butera hydrolytike clavage, itera ibara rya tablet, ihindura imyirondoro yiseswa, kandi irashobora guhindura imikorere ya kristaline ikora muburyo bwa amorphous idakora.

Igiciro kinini cyo gupakira inenge: Hydrolysis, Gutesha agaciro, hamwe no Kwibutsa

Pinehole imwe mumyanya ya blister ibangamira kurinda ibiyobyabwenge. Mu masoko agenzurwa cyane hakurikijwe amabwiriza ya FDA, EMA, na ICH, ihungabana ryicyiciro riterwa nubusembwa bwo gupakira ritera kwibutsa ibicuruzwa bihenze, kuburira amabwiriza, no kwangiza cyane ibicuruzwa.

Ubunini bubi na Pinhole Ubucucike & WVTR Barrière Matrix

Porogaramu yibanze ya farumasi isaba Zeru-Pinhole Ubunyangamugayo

Impapuro zipakira zeru-pinhole ningirakamaro muburyo bwo gutanga ibiyobyabwenge byoroshye:

Ibibazo

Q1: Ni ubuhe busobanuro bwa tekinike ya pinhole muri farumasi ya aluminium?

Igisubizo: Pinhole ni microscopique idafite icyuho cyangwa umwobo urambuye rwose binyuze muri fayili ya aluminium, byakozwe mugihe cyo kuzunguruka cyangwa guhindura. Mubikorwa bya farumasi, pinholes isuzumwa kubipimo bya ASTM E252 , hamwe na zeru zeru byemewe murwego rwibanze.

Q2: Ni ukubera iki 25μm cyangwa umubyimba wa aluminiyumu ifatwa nkinzitizi yuzuye yubushuhe?

Igisubizo: Ku bunini bwa 25μm (0.025mm) no hejuru, ubwinshi bwimashini ya materique ya aluminiyumu birinda pinholes kuzunguruka kwinjira mu bunini bwuzuye bwicyuma. Ibi bitanga igipimo cyogukwirakwiza Amazi Yumuyaga (WVTR) ya 0.000 g / m² umunsi.

Q3: Ese ubushyuhe-kashe cyangwa primers ikingira ikiraro micro-pinholes muri fayine yoroheje?

Igisubizo: Yego. Gukoresha icyuma kimwe, gikomeza ubushyuhe-kashe ya lacquer cyangwa primer layer (4.0 - 6.0g / m²) birashobora gufasha gufunga micro-void mumifuniko yoroheje (15μm - 20μm). Nyamara, kubijyanye na farumasi ikomeye, kwerekana insina ya aluminium idafite pinhole ikomeza kuba itegeko.

Q4: Ni izihe nyandiko zubahirizwa zitangwa kugirango hamenyekane ubuziranenge bwa zeru-pinhole?

Igisubizo: Ibyoherejwe birimo Icyemezo cyo Gusesengura (CoA) gifite umurongo uhoraho wa lazeri pinhole yogusuzuma, Raporo yikizamini cy’amazi yohereza amazi (WVTR) (kuri ASTM F1249), gusesengura ibyuma biremereye (RoHS / REACH), hamwe na FDA 21 CFR ibiryo / farumasi yubahiriza ibyemezo.

Q5: Nigute Changzhou Dingang Metal Material Co., Ltd. (Ubushinwa) yemeza ko umukungugu wa zeru wanduye mugihe cyo gutemba?

Igisubizo: Dingang Metal Material Co., Ltd. ikora ibikoresho byo gusukura ubwiherero bifite ibikoresho bya karbide bikarishye cyane, ibyuma byo mu kirere byikora, hamwe n’ibikoresho byo gukuramo ivumbi. Iyi nzira irinda aluminiyumu kunyunyuza umukungugu kwanduza hejuru ya file.

Umwanzuro

Kugaragaza Gutesha agaciro Icyiciro cya aluminiyumu ningirakamaro mugukora neza cyane, gucapa, no kumurika. Kurandura amavuta yo hejuru yemeza neza ko bifatanye neza, bikarinda gusenyuka, kandi byemeza ko amabwiriza yubahirizwa mu biribwa, imiti, hamwe n’ikoranabuhanga ryo mu rwego rwo hejuru.