Aka gatabo kagenewe abashinzwe umusaruro wa aerosol, abanyamwuga ba R&D, ninzobere mu gutanga amasoko. Itanga incamake yuburyo bwa farumasi yindege ya aerosol, ibipimo byo gutoranya, kuzuza inzira, hamwe no kubahiriza amabwiriza, bigufasha gufata ibyemezo byuzuye muri buri cyiciro cyiterambere ryibicuruzwa no gushakisha ibikoresho.
1. Abamamaza: Imbaraga za Pharmaceutical Aerosol
Imashini zikoresha ni ikintu cy'ibanze kigizwe na farumasi ya farumasi, itanga imbaraga zo gutwara ibiyobyabwenge muri spray yuzuye, itajegajega, na atome. Kubijyanye nihame ryakazi, moteri isanzwe ifite ingingo zitetse munsi yubushyuhe bwicyumba cyumuvuduko wikirere kandi bikagumana umuvuduko mwinshi wumuyaga imbere mubintu bifunze. Iyo valve ikozwe, umuvuduko wimbere urekurwa gitunguranye kumuvuduko wikirere, bigatuma moteri ihinduka vuba kandi ikaguka, ikavamo ibiyobyabwenge byamazi nkigicu cyiza. Mubisobanuro bimwe na bimwe, moteri ikora kandi nk'igishishwa cyangwa cyoroshye, bigira ingaruka ku bunini bw'igitonyanga, uburyo bwo gutera, no guta ibiyobyabwenge.
Guhitamo moteri ntabwo bigira ingaruka kumikorere yibicuruzwa gusa ahubwo bigira ingaruka no kumutekano wumurwayi no kuvura neza. Umuyoboro mwiza wa farumasi ugomba kuba wujuje ibi bikurikira:
Ibiranga umuvuduko : Umuvuduko wumwuka hejuru yumuvuduko wikirere mubushyuhe bwicyumba
Umwirondoro wumutekano: Ntabwo ari uburozi, non - allerge, ntabwo - irakaza
l Guhagarara: Inert - nta reaction yibiyobyabwenge cyangwa ibikoresho bya kontineri
l Ibintu bifatika: Ibara, impumuro nziza, uburyohe
l Umutekano: Ntabwo - gutwikwa, kudaturika
l Ubukungu: Birashoboka kandi byoroshye kuboneka
Nkuko amabwiriza y’ibidukikije yakajije umurego ku isi, guhitamo moteri byavuye mu cyemezo gishingiye ku mikorere gusa bigera ku bucuruzi bugoye burimo gukora neza, umutekano, ingaruka z’ibidukikije, no kubahiriza amabwiriza.
2. Ubwoko Bune Bwingenzi Bwamamaza
Ukurikije imiterere yimiti nihame ryakazi, imiti ya aerosol yimiti iri mubyiciro bine. Gusobanukirwa ibiranga, ibyiza, nimbibi za buri bwoko nibyingenzi mugutezimbere no guhitamo ibikoresho.
2.1 Hydrofluoroalkanes (HFAs) - Guhitamo Ibyingenzi
Hydrofluoroalkanes kuri ubu nicyiciro cyiza cyane cya moteri hamwe nogusimbuza inzira ya chlorofluorocarbone (CFCs). HFAs itanga ubushobozi bwa zeru ozone, uburozi buke, hamwe no guhagarara neza. Zikoreshwa cyane mubuvuzi bwa asima na COPD, cyane cyane mubitutu byapimwe - dose ihumeka (pMDIs).
Ibintu bibiri bikunze kugaragara cyane muri HFA muri farumasi yimiti ni:
(1) HFA - 134a (Tetrafluoroethane)
HFA - 134a ni yo ikoreshwa cyane na moteri ya HFA, ifite aho itetse ‑26.3 ° C hamwe n’umuvuduko ukabije w’umwuka. Ifite imiti ihamye kandi itanga umuvuduko uhoraho mubushyuhe bwicyumba, bigatuma imiti isohoka nkigicu kimwe, cyiza. Hafi ya HFA - ishingiye kumyuka ya aerosole ikoresha HFA - 134a nka moteri.
(2) HFA - 227ea (Heptafluoropropane)
HFA - 227ea ifite aho itetse ‑17.3 ° C, hejuru gato ya HFA - 134a, hamwe n’umuvuduko ukabije w’umwuka. Ibi bituma bigira akamaro mubisobanuro bisaba imbaraga zoroshye zo gutera. Inzobere mu nganda ziteganya kuzamuka cyane mu ikoreshwa rya HFA - 227ea muri farumasi y’imiti mu gihe kiri imbere.
Mubikorwa, moteri ya HFA irashobora guhuzwa hamwe n-imashanyarazi nka Ethanol kugirango ibashe gukemura ibibazo. Corticosteroid pMDI, urugero, akenshi iba irimo Ethanol hafi 13% kugirango yongere ibiyobyabwenge. Kuvanga ibyuma bibiri cyangwa byinshi bya HFA bituma abayikora bakora neza - guhuza imyuka yumuyaga nibiranga atomisiyoneri.
2.2 Imyuka ihumanye - Umutekano-Ihitamo rya mbere
Imashini ya gaze isunitswe irimo azote (N₂), dioxyde de carbone (CO₂), na okiside ya nitrous (OYA). Izi moteri zikora mukoresheje imbaraga zoroshye z'umubiri - gaze ibikwa munsi yumuvuduko mwinshi, kandi ibikorwa bisohora uwo muvuduko wo kwirukana ibiyobyabwenge.
Ibyiza byibanze bya gaze zifunitse ni imiterere yimiti yabyo, idashya, nuburozi buke. Azote irahagaze neza cyane, ntishobora gufata imiti, kandi ntishobora gushonga mumazi. Dioxyde de Carbone nayo irahagaze ariko ifite amazi meza cyane, ashobora gutera ihindagurika ryigihe.
Nyamara, imyuka ihumanye ifite aho igarukira. Iyo imyuka idasukuye yuzuye yuzuye ubushyuhe bwicyumba, umuvuduko wimbere ugabanuka gahoro gahoro ukoresheje, biganisha kumikorere ya spray idahuye. Byongeye kandi, imyuka ifunitse itanga ibitonyanga bito cyane, bigatuma bidakwiriye guhumeka neza bisaba ibihaha byimbitse. Kubwibyo, imyuka ihumanye iboneka cyane muri aerosole yibanze, ibicuruzwa byangiza ikirere, hamwe nibisabwa aho atomisiyo nziza idakomeye.
2.3 Hydrocarbone - Guhitamo Ubukungu
Amashanyarazi ya hydrocarubone arimo propane, n butane, na isobutane. Ibyiza byabo byingenzi nigiciro gito, uburozi buke, nubucucike hafi yamazi.
Ingaruka nyamukuru ya hydrocarbone ni ugutwika no guturika, bisaba gucunga umutekano cyane mugihe cyo gukora no kubika. Kubera iyo mpamvu, hydrocarbone ikoreshwa gake muri aerosole yimiti; mubisanzwe bahujwe na CFCs kugirango bagabanye ibyago byo gutwikwa. Muri iki gihe, hydrocarbone ikunze kuboneka mubicuruzwa bya aerosol byabaguzi nko kumera umusatsi hamwe na fresheners yo mu kirere, hamwe nibisabwa bike muri aerosole yimiti.
2.4 Chlorofluorocarbons (CFCs) - Yataye igihe
Chlorofluorocarbons, izwi cyane nka Freon, irimo trichlorofluoromethane (CFC 11), dichlorodifluoromethane (CFC 12), na dichlorotetrafluoroethane (CFC 114). Mu kinyejana cya 20, CFC ni zo zikoreshwa cyane muri aerosole ya farumasi, zahawe agaciro kubera kutagira imiti, uburozi buke, hamwe n’umuvuduko uhamye.
Nyamara, CFCs wasangaga igabanya isi ya ozone. Muri Protokole ya Montreal ku bintu bigabanya urwego rwa Ozone, ibihugu byashyize umukono ku masezerano byemeje guhagarika umusaruro wa CFC ku isi hose. Ubushinwa bwahagaritse gukoresha CFC muri aerosole y’ibanze guhera ku ya 1 Nyakanga 2007, no mu guhumeka ikirere guhera ku ya 1 Mutarama 2010. Nyuma y’itariki ya 1 Nyakanga 2013, na none byari bibujijwe gukora aerosole y’imiti idahumeka hakoreshejwe CFCs. Imashini ya CFC ubu ni ikibazo cyamateka muri aerosole yimiti.
3. Uburyo abamamaza bafite uruhare mu kuzuza ikoranabuhanga - Icyerekezo cya OEM
Guhitamo moteri ikora muburyo butaziguye igishushanyo mbonera. Iki nikibazo gikomeye cyane cya tekiniki kubakora aerosol.
3.1 Kuzuza igitutu hamwe no kuzura ubukonje
Hariho inzira ebyiri zingenzi zokuzuza moteri yuzuza imiti ya farumasi:
Kuzuza igitutu ninganda zinganda. Inzira zikurikirana ni: kuzuza amazi kuzuza → valve crimping → inshinge ya moteri ikandamijwe. Pompe ya booster ikuramo moteri ivuye mu bubiko, ikayihatira kumera neza, ikayigeza kuri silinderi yo gupima kugirango yuzuze. Kuzuza igitutu bikora neza kuri moteri nyinshi za HFA hamwe na gaze zifunitse, hamwe nibikoresho byikoranabuhanga bikuze kandi bitanga umusaruro mwinshi.
Kwuzuza ubukonje bisaba gukonjesha kugeza kuri 5 ° C munsi yacyo aho mbere yo kuzura. Ubu buryo busaba gukonjesha ibikoresho n'ibikoresho bigera kuri 20 ° C, bigatuma ishoramari ryinshi n’ikoreshwa ry’ingufu. Kwuzuza ubukonje mubisanzwe bigenewe ubushyuhe bukabije cyangwa ibisabwa byihariye byo gukora.
3.2Tube Valve vs BOV (Umufuka kuri Valve) Sisitemu
Urebye uburyo bwo gupakira, aerosole yimiti iri mubyiciro bibiri byingenzi:
Sisitemu ya Tube Valve ibamo ibiyobyabwenge hamwe na moteri hamwe muri aerosol irashobora kudatandukana kumubiri. Nubwubatsi bwa aerosol gakondo. Inzira igenda ni: kugaburira kontineri → kuzuza amazi → gushyiramo valve → guhonyora → kuzuza moteri → kugenzura ubuziranenge no gupakira.
Sisitemu ya BOV (umufuka onvalve) igera ku gutandukana kwumubiri hagati yibiyobyabwenge na moteri - ibiyobyabwenge bikubiye mumufuka woroshye imbere muri kanseri, mugihe moteri ifata umwanya uri hagati yumufuka nurukuta. Igishushanyo gitanga umutekano n’isuku birenze, kuko ibiyobyabwenge bitigera bihura na moteri, bigatuma biba byiza kumiti myinshi cyangwa itajegajega. Inzira igenda ni: kugaburira kontineri → gushyiramo valve → kuzuza no gutembagaza → kuzuza amazi ku gahato. Kubantu bashya binjira mubikorwa bya aerosol, igikapu kubikoresho bya valve birasabwa cyane kubera ubworoherane, umutekano, kwiringirwa, nigiciro giciriritse.
3.3 Ibikoresho by'ibanze Ibisobanuro
Mugihe uhitamo ibikoresho byuzuye, ababikora bagomba kwibanda kubipimo bikurikira:
Kuzuza ubunyangamugayo: Imirongo igezweho yuzuye ya aerosol yuzuza igera kuri ± 0.5% kugeza kuri ± 1%, ikoreshwa na tekinoroji yo kugenzura servo
Umusaruro winjiza: Imirongo isanzwe yuzuza aerosol ikora kumabati 1.200-15.500 kumasaha
Guhinduranya: Ibikoresho bigomba kwakira byinshi bishobora kuba binini (diameter 35-75 mm) nubwoko butandukanye
Ibiranga umutekano: HFA hamwe na hydrocarubone yuzuza ibintu bisaba gushushanya ibimenyetso biturika hamwe na sisitemu yo gutahura
4. Ibitekerezo bitandatu byingenzi byo gutoranya abamamaza
Guhitamo icyuma gikwirakwiza bikubiyemo kuringaniza ibintu byinshi. Dore ibipimo bitandatu abafata ibyemezo bya tekiniki bagomba gusuzuma:
4.1 Guhuza ibiyobyabwenge
Ibiyobyabwenge - guhuza imbaraga nicyo kintu cyibanze. Umuvuduko ntugomba gufata imiti hamwe nibikoresho bikora bya farumasi (API) cyangwa gutesha agaciro imiti. Icyuma cya HFA cyiza cyane muriki kibazo - kirahagaze neza kandi gihuza na API nyinshi.
4.2 Intego ya Atomisiyoneri
Porogaramu zitandukanye zamavuriro zisaba ubunini butandukanye. Ibicuruzwa bihumeka bihumeka bisaba ibitonyanga byiza (mubisanzwe diameter ya aerodynamic ya diametre ya metero 1-5) kugirango ibihaha byimbitse. Imashini ya HFA niyo ihitamo guhitamo guhumeka aerosole bitewe nibiranga atomisiyasi iranga. Ikirere cya aerosole ntigikenewe cyane muburyo bwiza bwo gutonyanga, gukora imyuka ihumanye cyangwa hydrocarbone ihitamo neza.
4.3 Umwirondoro wumutekano
Umutekano ukubiyemo ibipimo byinshi: uburozi bwo guhumeka, kurakara kuruhu, uburozi bwa sisitemu, hamwe no gutwikwa / guturika. Imashini ya HFA ifite umwirondoro mwiza wumutekano - ntabwo - uburozi kandi burakaza cyane. Hydrocarbone itera ibyago byo gutwikwa, bisaba guturika - ibikoresho byuzuza ibimenyetso hamwe na protocole ikomeye.
4.4 Kubahiriza ibidukikije
CFCs yarangije burundu - iyi ni inzira idasubirwaho. Mugihe HFAs ozone - inshuti, iracyafite ubushobozi bwo gupima ubushyuhe bwisi (GWP). Ibikurikira - ibisekuru bike - moteri ya GWP nka HFO - 1234ze zirimo gukorwaho iperereza kandi zishobora kuvuka nkizindi nzira. Ababikora bagomba gukurikirana imigenzereze yerekeye GWP.
4.5 Ubukungu
Imashini ya HFA ihenze cyane kuruta imyuka ya gaze na hydrocarbone. Kubisabwa aho imikorere ibemerera, imyuka ihumanye itanga igiciro gito - igisubizo. Nyamara, kubicuruzwa bihebuje nko guhumeka aerosole, ibyiza byo gukora bya moteri ya HFA byerekana igiciro cyabyo.
4.6 Guhuza inzira
Ubwoko butandukanye bwimodoka bushiraho ibisabwa bitandukanye mukuzuza ibikoresho. Imashini ya HFA ikeneye igitutu systems sisitemu yo kuzuza ibipimo hamwe no kugenzura neza ibipimo. Hydrocarbone isaba guturika design igishushanyo mbonera no gutunganya gaze ya inert. Isakoshi - kuri - sisitemu ya sisitemu ikenera ibikoresho byuzuza imifuka.
5. Ahantu nyaburanga
5.1 Urwego mpuzamahanga
Amasezerano ya Montreal ku bintu bigabanya urwego rwa Ozone ni amasezerano shingiro yo gukuraho CFC ku isi yose, hamwe n’ibihugu birenga 160 byashyizeho umukono. Amerika yabujije CFC mu kirere kitari - ubuvuzi guhera mu 1978, pMDI yasonewe kugeza igihe habaye ubundi buryo bukwiye.
5.2 Amabwiriza y'Ubushinwa
Ubushinwa bwinjiye mu masezerano ya Montreal mu 1991 hanyuma bukurikiza gahunda yo gukuraho icyiciro cya CFC cyo gukuraho aerosole ya farumasi. Amabwiriza yo mu 2006 yasabye guhagarika ikoreshwa rya CFC muri aerosole y’ibanze guhera ku ya 1 Nyakanga 2007, no mu kirere cyo guhumeka guhera ku ya 1 Mutarama 2010. Irindi tangazo ryakozwe mu 2013 ryabuzaga ikoreshwa rya CFC mu kirere cya farumasi idahumeka guhera ku ya 1 Nyakanga 2013.
5.3 Ibipimo byiza
Ibice Rusange bya USP <5> na <601> byerekana ibisobanuro birambuye kugirango bipimishe ubuziranenge bwibicuruzwa no kuranga imikorere ihumeka hamwe na aerosole yizuru, harimo gutanga ibipimo bihwanye no gukwirakwiza ingano ya aerodynamic. FDA ikomeje kuvugurura ubuyobozi ku nzibacyuho igenda, ishimangira kugereranya vitro no gusuzuma umutekano w’amavuriro. Abakora ibicuruzwa bitezimbere ibicuruzwa bagomba kwifashisha ibipimo ngenderwaho kugirango barebe ko byubahirizwa.
6. Ibihe bizaza muburyo bwa tekinoroji
6.1 Abamamaza-GWP
Mu gihe impungenge z’imihindagurikire y’ikirere zigenda ziyongera, GWP ya moteri ya HFA iraza gukurikiranwa n’amabwiriza. Ibikurikira - ibisekuru bike - moteri ya GWP nka HFO - 1234ze zirimo gukorwaho iperereza, hamwe na fiziki ya chimique isa na HFAs, ikabashyira mubishobora gukurikira - ibisekuruza bizakurikiraho. Uruganda rwa farumasi ya aerosol rurimo gusuzuma neza niba bishoboka n’umutekano by’izo moteri nshya.
6.2 Guhindura imikorere yuburyo bugenga inzibacyuho
FDA irimo gutekereza cyane kubijyanye namakuru asabwa kugirango inzibacyuho igenda, igamije guteza imbere guhuza isi no kwihutisha ihinduka riva kuri - GWP rikagera kuri moteri ya GWP. Ababikora bagomba gutegura mbere bakubaka ububiko bwa tekiniki kugirango bategure imiraba mishya yo gusimbuza moteri.
6.3 Ubuvuzi gakondo bwabashinwa Topical Aerosols
Gusimbuza cyane imiti gakondo yubushinwa (TCM) aerosole yibanze nayo iratera imbere, hamwe na HFA - 134a, HFA - 227ea, na dimethyl ether byose byigwa nkabasimbuye CFC. Aka gace karacyatanga ibyumba byinshi byo gutezimbere no gutezimbere.
7. Amabwiriza yo gutanga amasoko kubakora inganda za Aerosol
7.1 Inzira nshya yo Gutezimbere Ibicuruzwa
Ku masosiyete ateganya kwinjira mu nganda za aerosol, turasaba intambwe ikurikira - by - inzira:
Sobanura aho ibicuruzwa bihagaze: Guhumeka cyangwa ni ngombwa? Ibicuruzwa bihumeka bisaba moteri ya HFA; ibicuruzwa byingenzi birashobora kuba bikwiranye na gaze zifunitse cyangwa hydrocarbone.
Suzuma uburyo bwo kuzuza: Ukurikije ibiranga ibicuruzwa nubunini bwibicuruzwa, hitamo kimwe - igice cyangwa bibiri - bigize (umufuka - kuri - valve) sisitemu, hamwe no kuzuza igitutu cyangwa inzira yuzuye ubukonje.
l Guhitamo ibikoresho: Ubwoko bwa moteri bumaze kwemezwa, hitamo ibikoresho byuzuye. Abinjira bashya basabwa gutangirana nisakoshi - ku bikoresho bya valve; inganda nini zigomba gutekereza byuzuye kuzuza imirongo.
l Isuzuma ryibanze: Emeza ko moteri yatoranijwe yujuje ibyangombwa byo kwiyandikisha kumasoko yagenewe, kandi utegure CMC namakuru ahamye mbere.
7.2 Ibipimo byo gutoranya ibikoresho
Nkumushinga wuzuza ibikoresho, turagira inama ibigo bitanga umusaruro gusuzuma abashobora gutanga isoko kubintu bikurikira:
Ubuhanga bwo gutunganya : Ese utanga isoko yaba afite uburambe mugushushanya no gukora ibikoresho bihuye nubwoko wahisemo?
l Ibyiringiro byukuri: Ibikoresho bigera kubwuzuzanye bwa ± 1% cyangwa byiza?
l Ibiranga umutekano: Ese guturika design igishushanyo mbonera hamwe na sisitemu yo gutahura ibyashizwemo na moteri ya HFA na hydrocarubone?
l Ubushobozi bwuzuye - umurongo: Ese utanga isoko ashobora gutanga igisubizo cyuzuye cyumurongo gikubiyemo kugaburira ibintu, kuzuza, guhonyora, gupima amazi yo koga, hamwe na label?
l Nyuma - inkunga yo kugurisha no kuyitunganya: Ese utanga isoko ashyigikira ibikoresho byo gutunganya ibikoresho, igenamigambi ryimiterere, hamwe nogushira mubikorwa?
8. Umwanzuro
Guhitamo kwimiti ya aerosole yimiti ni sisitemu yubuhanga bugizwe na siyanse yibiyobyabwenge, kuzuza ikoranabuhanga, kubahiriza amabwiriza, hamwe ninshingano z’ibidukikije. Ihinduka riva muri CFC rijya muri HFAs ryerekana iterambere ry’ibidukikije ku isi ndetse n’iterambere rihoraho mu ikoranabuhanga ryuzuza aerosol.
Ku bakora inganda za aerosol, gusobanukirwa ibiranga ubwoko butandukanye bwa moteri, kumenya uburyo bwo kuzuza ibintu, hamwe no kugendana nubu hamwe niterambere ryiterambere niterambere ryikoranabuhanga nurufunguzo rwo guteza imbere ibicuruzwa neza no kubyaza umusaruro neza. Nkumushinga wihariye wuzuza ibikoresho, twiyemeje gutanga ibikoresho byizewe hamwe nogutunganya ibikoresho byubwubatsi kubakora inganda za aerosol kwisi yose - haba kubireba - HFA ihumeka neza ya aerosol yuzuza cyangwa igikapu cyizewe - kuri - valve yamashanyarazi, dutanga ibisubizo byagaragaye.
Niba uteganya umurongo wa aerosol cyangwa utekereza kuzamura ibikoresho, nyamuneka twandikire kugirango ubone ubufasha bwa tekiniki.
