Wɔ nnuruyɛ ne aduannuru adwumayɛbea ahorow mu no, wɔde nnuru a wɔde di dwuma wɔ aduru a wɔde kapsul mu di dwuma kɛse esiane sɛ ɛnyɛ den sɛ wɔde bɛfa so na etumi kata hua a ɛnyɛ dɛ so nti. Wɔn mu no, enteric-coated capsules, sɛ nnuruyɛ mu mmoa titiriw a ɛyɛ adwuma, di dwuma titiriw. Wɔ adetɔ anaa R&D nhyehyɛe no mu no, nnwumakuw pii a wɔyɛ nnuru de wɔn adwene si ade titiriw bi so: Bere bɛn na ɛpaapae wɔ enteric-coated capsules mu? Saa asɛm yi bɛhwehwɛ saa asɛm yi mu kɔ akyiri de aboa wo ma woanya ntease a emu dɔ wɔ mpaapaemu su ne hia a ɛho hia wɔ enteric-coated capsules ho.
I. Standard Disintegration Bere a Enteric-Coated Capsules
Sɛnea China Pharmacopoeia ne ɔman gyinapɛn ahorow a ɛfa ho kyerɛ no, wɔakyerɛkyerɛ bere a wɔde mpaapaemu a ɛwɔ enteric-coated hard capsules mu no mu katee. Sɛ yɛbɛka no tiawa a, wɔakyekyɛ ne mpaapaemu no mu abien, na ɛne nneɛma a atwa yɛn ho ahyia a ɛwɔ onipa nipadua mu akwaa ahorow a ɛma aduan mu yɛ den no hyia:
Yafunu mu Nsuo a Atwa Yɛn Ho Ahyia (Acid-Resistant Stage):
Ɛsɛ sɛ yafunu mu nsu a ɛwɔ yafunu mu no kɔ so yɛ nea ɛyɛ den wɔ yafunu mu nsu mu a ɛnpaapae anaasɛ ɛntu. Mpɛn pii no, gyinapɛn no hwehwɛ sɛ wɔ nnɔnhwerew 2 akyi a ɛwosow anaasɛ wɔde bɛhyɛ yafunu mu nsu a wɔde ayɛ (pH 1.2 hydrochloric acid solution) mu no, ɛnsɛ sɛ capsule no da sɛnkyerɛnne biara adi sɛ mpaapaemu, apaapae, anaasɛ emu nsɛm no atu. Eyi yɛ sɛnea ɛbɛyɛ a aduru no bɛfa yafunu no mu dwoodwoo, na amma yafunu mu acid nsɛe aduru no mu nneɛma anaasɛ aduru no anhyɛ yafunu no mu ntini no abufuw.
Nsuo a Ɛwɔ Dwotwaa Mu (Disintegration Stage):
Sɛ capsule no hyɛn dwensɔtwaa no mu a, ɛsɛ sɛ ɛma aduru no fi adi ntɛmntɛm. Gyinapɛn no hwehwɛ sɛ wɔde capsule a wɔasɔ ahwɛ wɔ yafunu mu nsu mu no kɔ dwensɔtwaa mu nsu a wɔde ayɛ (pH 6.8 phosphate buffer) mu, baabi a mpɛn pii no wɔhwehwɛ sɛ bere a ɛpaapae no yɛ simma 60 (gyinabea a ɛkorɔn bi hwehwɛ bere tiaa bi, te sɛ simma 30 mu). Bere pɔtee no gu ahorow kakra gyina nea ɔyɛe no kwan ne ne nhwɛso so, nanso nnyinasosɛm titiriw no ne sɛ "ɛpaapae bere a woadu dwensɔtwaa no mu".
Enti, bere a mpaapaemu a ɛwɔ enteric-coated capsules no nyɛ akontaabu biako, na mmom ɛyɛ nhwɛso a edi mũ a ɛkyerɛ sɛ "ɛpaapae wɔ yafunu mu nsu mu ( Ɛboro anaasɛ ɛne nnɔnhwerew 2 yɛ pɛ)" ne "ɛpaapae ntɛmntɛm wɔ dwensɔtwaa mu nsu mu ( Ennu anaasɛ ɛne no yɛ pɛ simma 60)".
II. Dɛn Nti na Bere a Wɔde Paapae Ho Hia Saa?
Nsusuwii adwene a ɛwɔ enteric-coated capsules ho ne "site-specific release". Sɛ bere a wɔde paapae no nyɛ nea ɛfata a, ebetumi de nneɛma a emu yɛ den aba:
Ntɛmntɛm a Ɛpaapae (Wɔ Yafunu Mu): Eyi betumi ama yafunu mu acid asɛe aduru no, na ɛtew sɛnea ɛyɛ adwuma no so; anaasɛ aduru no betumi ahyɛ yafunu no abufuw, na ɛde ɔhaw ahorow te sɛ akisikuru ne ɔfe aba.
Delayed Disintegration (Wɔ dwensɔtwaa Mu): Sɛ capsule no mu paapae brɛoo dodo wɔ dwensɔtwaa no mu a, wontumi nyi aduru no mfi baabi a eye sen biara a ɛtwetwe wɔ dwensɔtwaa ketewa no mu, na ɛma ɛtwetwe no so tew anaasɛ mpo wɔayi afi nipadua no mu ansa na wɔayi afi mu.
Enti, bere a wɔde paapae no a wɔbɛhwɛ so denneennen no yɛ ade titiriw a ɛbɛma wɔahwɛ ahu sɛ aduru no betumi ayɛ bioavailability ne ayaresa mu mfaso.
III. Nneɛma a Ɛka Bere a Wɔde Paapae
Ɛwom sɛ ɔman gyinapɛn ahorow wɔ mmara ahorow a ɛyɛ biako de, nanso wɔ sɛnea wɔde di dwuma ankasa mu no, nneɛma ahorow betumi anya bere a wɔde paapae mu no so nkɛntɛnso:
Raw Material Composition: Mpɛn pii no, enteric capsules a ɛyɛ papa-quality de gelatin a wɔde enteric coating materials (te sɛ Cellulose Acetate Phthalate CAP, Acrylic resin, ne nea ɛkeka ho) akata so na edi dwuma. Sɛnea ade a wɔde kata so no mu duru ne sɛnea ɛyɛ pɛ no kyerɛ bere a ɛko tia acid ne ahoɔhare a ɛpaapae no tẽẽ.
Tebea a Wɔde Sie: Nsu a ɛyɛ nwini ne ɔhyew ka capsule no akorade no kɛse. Nsu a ɛyɛ nwini dodo betumi ama capsule no abon no ayɛ mmerɛw, na asakra ne honam fam su na ɛnam so aka bere a ɛpaapae no.
Nneɛma a Ɛwɔ Mu Su: Sɛ nnuru a wɔde ahyɛ mu ma anaa granules no wɔ hygroscopicity anaasɛ pH soronko a, ebetumi ne capsule ade no adi nkitaho, na asiw ɔkwan a ɛfata a wɔfa so paapae no kwan.
IV. Awie
Sɛ yɛbɛbɔ no mua a, dɛn ne bere a ɛpaapae noenteric-a wɔde akata so capsules? Mmuae no ne sɛ: ɛnyɛ nea ɛpaapae wɔ nnɔnhwerew 2 mu wɔ yafunu mu nsu a wɔde ayɛ mu, na mpɛn pii no, ɛpaapae wɔ dɔnhwerew 1 mu wɔ dwensɔtwaa mu nsu a wɔde ayɛ mu. Wɔ nnuruyɛ nnwumakuw fam no, sɛ wɔbɛpaw obi a ɔde enteric-coated capsules a ɛne pharmacopoeia gyinapɛn ahorow hyia na ɛma su a ɛyɛ den ma no ne ade a ɛsɛ sɛ wodi kan yɛ na ama wɔahwɛ ahu sɛ nnuru no yɛ nea ahobammɔ wom na ɛyɛ adwuma yiye. Bere a woretɔ ade no, hwɛ hu sɛ wobɛbisa nhwɛsode ahorow ama wɔasɔ ahwɛ bere a ɛpaapae mu de ahwɛ ahu sɛ ade no di wo nhyehyɛe pɔtee ahwehwɛde ahorow ho dwuma. Sɛ nsɛmmisa bi wɔ hɔ a ɛfa capsules a hwee nni mu ho a, yɛma wo akwaaba sɛ wo ne KornnacCaps nni nkitaho.
