Mmepe Peptide ọnụ: Ihe akaebe tupu ị gbanwee

Kedu ka e si ekpebi mmepe peptide ọnụ: njirisi nke na-ekpebi ntụnyere

A na-ekpebi mmepe peptide ọnụ na njirisi ise, ma otu ise ahụ na-ekpebi akụkụ ọ bụla nke ntụnyere a: nkwụsi ike, permeability, dose agbanwe agbanwe, nbibi na njikwa adịghị ọcha, na ihe akaebe atụnyere. Nhọrọ abụọ a bụ ngwugwu ihe akaebe, ọ bụghị ndị na-ere ahịa. Otu bụ onye na-azọ ọkwa ọnụ; nke ọzọ bụ njikwa injectable ọ ga-emerịrị.

Ebe mmalite bụ ọnụego ntọala. Nyochaa oke-PK na-akọ na bioavailability ọnụ maka peptides ezubere maka ime usoro na-adịkarị n'okpuru. 1% ọbụlagodi n'okpuru ọnọdụ kachasị mma, megide ike ike 10-25% maka nnyefe insulin pulmonary. Usoro mgbakọ na mwepụ nke dose maka sub-1% bioavailability na-esote ozugbo: a 0.4-1.0% bandwit zuru oke nwere nnukwu inter- na mgbanwe dị n'ime isiokwu na-akwalite ọnụọgụ ọnụ site na ihe ndị 10 ka 100.

Ọnụ ọgụgụ ahụ na-akpali ajụjụ nke abụọ, ma akwụkwọ na-egosi ugboro ole mmemme na-ada. Ọ naghị egosi ya nke ọma. Nlebanya nleba anya nke nleba anya nke nbipụta-ịhụnanya doro anya: ọdịda na kwụsị mmemme bụ n'usoro n'usoro erughị eru, yabụ enweghị ike iji obi ike gụọ mmemme dara ada site na ndekọ ebipụtara.

Ntugharị igodo: Kpebie onye na-aga ọnụ na nkwụsi ike, permeability, dose agbanwe agbanwe, nbibi na njikwa adịghị ọcha, na ihe akaebe atụnyere. Na akaebe dị ugbu a, Ọ dịghị onye na-aga ime ọnụ ka a ga-emeso ya dị ka mgbanwe na njikwa injectable.

Ntụnyere ngwa ngwa: ihe nhọrọ nke ọ bụla nwere igosipụta

Ntụnyere ọnụ na ntụnyere peptide injectable abụghị ajụjụ nke mmasị. Ọ bụ ajụjụ nke ihe akaebe nke ụzọ ọ bụla nwere ike iwepụta, na ole n'ime ya ndị nchịkwa na ndị nyocha ga-anabata.

Ahịrị ịba ụba nke dose bụ ebe ntụnyere na-atụgharịkarị. Na ntụnyere otu dose nke akara Mycapssa, 20 mg oral octreotide mepụtara mkpughe sistemu yiri nke ahụ 0.1 octreotide subcutaneous, na Cmax 33% ala na tmax nke 1.67-2.5 awa megide 0.5 awa.

Ahịrị ọ bụla dị n'elu na-aghọ ntụle nleba anya na ngalaba na-esote.

Nkwụsi ike: nke nhọrọ na-ejide ike ya site na ndụ shelf?

Njikwa injectable na-emeri na nkwụsi ike taa, na ọ na-emeri maka ihe nhazi: Naanị peptide ya kwesịrị ịdị ndụ nchekwa, mgbe onye na-aga ime ọnụ ga-adị ndụ nchekwa na mgbe ahụ eriri afọ.

Ndị ahụ bụ ụdị ọdịda atọ dị iche iche, ọ bụghị otu. Nkwụsi ike kemịkalụ na-ekpuchi ọkpụkpụ azụ peptide na agbụ akụkụ. Nkwụsi ike nke proteolytic na-ekpuchi ihe enzymes gastric na eriri afọ na-eme n'usoro mgbe emechara ya. Ndakọrịta dị ụtọ na-ekpuchi mmekọrịta dị n'etiti peptide na ihe niile emebere gburugburu ya. Onye na-azọ ọkwa nwere ike ịgafe nke mbụ wee daa nke abụọ, nke mere na profaịlụ ntọhapụ dị ọcha na-ekwu ntakịrị banyere ịdị ndụ ọnụ.

Edebere ihe nyocha maka ajụjụ kemịkalụ. Nke I Q1A(R2) matriks na-anwale nrụgide na-akọwapụta ọnọdụ okpomọkụ n'ime 10 Celsius C na-abawanye karịa ọnọdụ agbakwunyere, iru mmiri ebe kwesịrị ekwesị, oxidation, photolysis, na hydrolysis gafere pH, ma choro ka usoro nyocha kewapụ API na ndị na-emebi emebi. Oxidation, deamidation, hydrolysis na aggregation bụ ụzọ nke matrix e mere iji kpughee.

Nuance dị mkpa: ihe injectable anaghị eguzosi ike ozugbo. Ọ na-ebu oke oyi-agbụ na ihe egwu nchịkọta nke ya. Mana ajụjụ nkwụsi ike ya ka bụ ajụjụ nchekwa. Onye nkwuputa okwu anaghị eme. Nke nyocha nke ọdịda calcitonin na-egosi ka ọdịiche ahụ si emechi mmemme: ezughị oke absorption nke afọ, mkpokọta plasma na njedebe nke nchọpụta, na mfu ike fibrilization na-ebute.

Nkwenye: Kedu nhọrọ na-enweta peptide n'ofe mgbochi ahụ emebibeghị?

Njikwa injectable na-enweta akara ngosi a kpamkpam, n'ihi na ọ dịghị mgbe ọ ga-agafe ihe mgbochi eriri afọ ma ọlị. Permeability bụ otu n'ime isi mmalite nke ntaramahụhụ dose nke onye nyocha: bioavailability ọnụ nke klaasị maka peptides nọ n'okpuru 1% n'ọtụtụ ọnọdụ, dị ka edepụtara na Nyochaa oke ala PK, nke mere na atumatu onu ogugu peptide na-agbaghari n'okirikiri ihe na-eme ka permeation kama gburugburu peptide n'onwe ya.

A na-amakwa etu ndị nkwalite ahụ si arụ ọrụ ugbu a. A 2025 mụọ na Nkwukọrịta okike achọpụtara usoro SNAC nke abụọ: ọ na-ejikọta ya na peptide na akwa oyi akwa na monomerizes ya dị ka surfactant, mgbe ahụ neutralizes na itinye n'ime lipid bilayer, na-akpụ ntụpọ akpụkpọ ahụ jupụtara na SNAC siri ike nke peptide na-emikpu, n'okwu nke ndị edemede, "ihe atụ na ngwa ngwa aja,” na iguzosi ike n'ezi ihe nke akpụkpọ ahụ mechaa. Ụzọ bụ transcellular, ọ bụghị paracellular.

Ogo mmetụta na-anọgide na-adịchaghị mma na enweghị ntụkwasị obi. Nha mmetụta nkwalite nke edepụtara na-egosi C10 nwere LMWH na 3.9-7.6% ikwu, desmopressin na 2.4% ikwu na subcutaneous megide roughly 0.2% maka mbadamba ahịa ahịa, Isis 104838 na 9.5% N'ihe gbasara intra-isimbido nke 2-28%, Insulin tregopil na 1.5-2.0%. Otu nlebanya ahụ na-akọwa nnukwu mgbanwe n'ime isiokwu n'ofe ọmụmụ niile, ya mere ndozi otu onye nkwalite maka nkwụsi ike peptide na permeability anaghị akwado ndekọ ụlọ ọgwụ.

Nkwekọrịta dose: nke nhọrọ na-ewepụta mkpughe amụma?

Njikwa injectable na-emeri na ngbanwe dose, na ọdịiche ahụ bụ ihe owuwu karịa ihe gbasara nrụpụta ka mma. Mbadamba ụrọ nwere ike ịgafe nnwale n'ụdị ọdịnaya ma ka na-ebuga ụmụ irighiri ihe na-etinye uche na ya, n'ihi na isi mmalite abụọ nọọrọ onwe ha dị iche na-anọdụ n'etiti nkwupụta akara na mkpughe usoro.

Mgbakọ dị n'azụ nkwupụta ahụ bụ ngụkọ nnabata-uru USP, nke na-ewepụta OFF = |M − X̄| + ks, na k = 2.4 maka n = 10 na 2.0 maka n = 30, T = 100.0% na ndabara, M = X̄ mgbe X̄ dara n'etiti 98.5% na 101.5%, AV ≤ L1 = 15.0, na enweghị unit n'èzí L2 = 25.0% iche site na M (USP General Isi <905>). Ịgafe ule ahụ na-egbochi ka esi ekesa peptide n'ụzọ ziri ezi n'ofe mbadamba. Ọ dịghị ekwu ihe ọ bụla banyere ole nke dose ọ bụla gafere mgbidi eriri afọ.

Ọrụ Ntụle ọnụ ọgụgụ ndị PK nke semaglutide ọnụ na-etinye akụkụ ahụ etinyere na ya 0.795% zuru oke bioavailability (95% CI 0.736–0.864), na pụtara F nke 0.76% na isiokwu ahụike na 0.69% na T2D, plateauing nso 1.4% na 120 nkeji nkeji tupu dose-ọnụ ọnụ (Clinical Pharmacokinetics nke Oral Semaglutide, 2021-05-10). N'akụkụ ndị ahụ, mgbakọ na mwepụ dose-multiplication na-aga n'ụzọ siri ike 100 ugboro dose nke parenteral maka mkpughe sistemu dakọtara, ya mere, ntakịrị ihe ikwu na-amagharị n'ime ụmụ irighiri ihe na-etinye obi gị dum na-aghọ nnukwu ọnyà zuru oke na mkpughe.

Nhọrọ nhazi na-agbanwe akụkụ ahụ mana anaghị ewepụ mgbanwe ahụ. Na nyocha ahụmahụ semaglutide ọnụ, 300 mg SNAC bụ ibu nkwalite kacha mma: ikpughe dị elu na 300 mg karịa na 150 ma ọ bụ 600 mg, na 300 A kwenyere na mg na-ezere mmiri ozuzo a na-ahụ na ibu dị elu (Ahụmahụ Semaglutide Oral, 2023-08-22). Mmekọrịta ahụ abụghị monotononic, nke mere na a ga-egosipụta nkwụsi ike nke peptides ọnụ n'ofe nkwalite karịa n'otu ebe..

Mmebi na njikwa adịghị ọcha: nke nhọrọ dị mfe iji mara?

Onye na-azọ ọkwa ọnụ na-enweta ọkwa a, na ọ na-emeri maka ihe nhazi kama ịbụ nke kemịkal: Mbadamba ụrọ ma ọ bụ capsule bụ ihe nyocha nwere ike ị nweta karịa karịa ọgwụ injectable na-adịghị mma, n'ihi na sample bụ homogenous, kwụsiri ike na ọnọdụ bench, enwere ike were nkeji n'otu ihe atụ.

Ntọala nkwụsi ike nke na-akwado ntụnyere bụ otu maka ụzọ abụọ ahụ, mana ụzọ ọnụ na-eme ka ọ dị mfe ime: njirimara nke MS nwere usoro ma ọ bụ nkewa peptide; ịdị ọcha na ihe ndị metụtara ya site na RP-HPLC ma ọ bụ UPLC; adịghị ọcha na profaịlụ na-emebi emebi site na LC-MS; Nnwale ahụ kwuru na ndabere ọdịnaya peptide zuru oke na net; ịdị n'otu n'otu n'otu n'otu; mgbasa maka ịrụ ọrụ ntọhapụ yana mịnyere nhazi; na ogologo oge na nkwụsi ike ngwa ngwa na mmebi mmanye. ICH Q1A kọwapụtara ihe nyocha mmanye-emebi emebi(R2) matriks na-anwale nrụgide, nke bụ ihe na-eme nkwudo na-emebi emebi ka ọ bụrụ ihe a na-atụghị anya ya.

Peptide Synthesis Njikwa injectable abụghị nsogbu njirimara siri ike karịa n'akụkụ ọ bụla. A na-achịkọta ibu adịghị ọcha ya site na nchịkọta, na-ekere òkè, na ịmụ nwa ma ọ bụ endotoxin, na njedebe endotoxin bụ mgbakọ na mwepụ, ọ bụghị ikpe: FDA endotoxin ịgba mgbakọ na mwepụ na-esetịpụ ọnụ ụzọ site na K/M, 5.0 EU/kg maka ụzọ intravenous, ya na a 0.5 EU/ml atụ ọrụ. Nke ahụ bụ nọmba akọwapụtara iji kụọ.

Ụzọ ọnụ na-agbakwụnye ụzọ mmebi nke injectable enweghị, na ndekọ ọdịda na-egosi ihe na-eme mgbe a na-edozighị ha n'oge. Na nyocha nke ọdịda calcitonin, Usoro salmon calcitonin ọnụ nke Phase III dara na nnabata afọ zuru oke, na mkpokọta plasma na njedebe nke nchọpụta, gbakọtara site na njedebe nke anụ ahụ ọkpụkpụ, nkesa nnabata na anụ ahụ na-abụghị ọkpụkpụ, na mfu ike fibrilization na-ebute. Ịdị ọcha nke gafere ọnụ ụzọ HPLC abụghị otu dị ka ịdị ọcha nke na-adị ndụ na nyocha nke ịkpa oke., na oghere ahụ bụ ebe nkwụsi ike peptide na ọrụ permeability ga-amalite.

Nchọpụta anyị: onye ndoro-ndoro onu onu di mfe iji mara n'echiche nke usoro onunu ogwu, na ike n'echiche rụrụ arụ. Ekwesịrị iji otu usoro nyocha mee nkwupụta abụọ a, ma ọ bụ ntụnyere abụghị ntụnyere.

Ihe akaebe ntule: ihe ọ na-ewe iji kwuo onye na-azọ ọkwa ọnụ dabara na njikwa injectable ya

Njikwa injectable na-emeri udi a na ndabara. Nkwenye ntunyere bụ nke Ụlọ ahịa nye onye ndoro-ndoro okwu, na isi ihe akaebe dị ugbu a anaghị ewepụta ya.

Ihe atụ kacha arụ ọrụ nke ọma bụ ntụnyere otu dose akara Mycapssa. N'ime ya, 20 mg ọnụ octreotide mepụtara mkpughe sistemu (AUC) yiri 0.1 Octreotide acetate subcutaneous, mana itinye uche na plasma kacha elu (Cmax) bụ 33% belata site n'ụzọ ọnụ, na oge ka elu (tmax) rutere na 1.67 ka 2.5 awa ọnụ megide 0.5 awa subcutaneously. Ngosipụta bụ nha nha nha n'ofe 3 ka 40 mg.

Dakọtara AUC na obere ala, E mesịa, ọnụ ọgụgụ kasị elu adabaghị na pharmacokinetics na pharmacodynamics. Ma ọdịiche dị na-adabere ma ọ bụ na ọ bụ mkpughe zuru oke na-ebute nrụpụta ọrụ ma ọ bụ site na ntinye uche kacha elu, na nke ahụ bụ ajụjụ ọgwụ ọ bụla, ọ bụghị ọkwa-ụzọ.

Usoro nhazi na-edozi ibu ahụ. N'okpuru FDA's ANDA vs 505(b)(2) usoro mkpebi, ANDA na-achọ ka ọ dịrị n'otu n'otu n'otu aka ahụ edepụtara ọgwụ n'ime ihe na-arụ ọrụ, usoro onunu ogwu, uzo, ike, ọnọdụ ojiji na labeling, nwere naanị ndịiche ekwere ekwe omume. A 505(b)(2) onye na-arịọ arịrịọ nwere ike ịdabere na akụkụ na nchoputa mbụ mana ọ ga-enyerịrị data na-akwado ọdịiche ọ bụla, a na-ahụkarị bioavailability ma ọ bụ nchikota, nri-mmetụta, na data ụlọ ọgwụ ma ọ bụ na-abụghị nke ụlọ ọgwụ dị ka achọrọ.

Mmetụta nri bụ ebe ibu ahụ na-atakarị ike. Ihe ndekọ data mmetụta nri Mycapssa na-edekọ ihe dịka 90% mbelata na ọnụego na oke nke absorption na nri, nke mere eji ejikọta doses na usoro ibu ọnụ kama ịhapụ onye ọrịa.

Ebe ụzọ ọnụ ọnụ na-emeri, na ebe njikwa injectable ka na-emeri

Ụzọ ọnụ na-emeri ebe ihe mgbochi na-abụghị nsogbu. Maka ebumnuche nke eriri afọ, peptide na-arụ ọrụ ebe ọ dịlarị, ya mere, akụkụ nke etinye uche na ya na-akwụsị ịbụ metric na-ekpebi. Ọrịa Crohn, ulcerative colitis na ọrịa nje na-akpata n'ime eriri afọ na-anọdụ n'ime otu ahụ, na klaasị megharịrị kemịkalụ arụpụtara maka ya, peptides nwere okpukpu abụọ na cyclic, Jide ọdịdị ha megide mmebi nke enzymatic ogologo oge ka ọ dị mkpa. Ọchịchị na-adịghị emerụ ahụ na iji enyi na-enwe ndidi na-esote otu echiche ahụ.

Njikwa injectable na-emeri ebe ọ bụla windo ọgwụgwọ dị warara, ebe arụmọrụ kacha elu na-akwalite kama ikpughe mkpokọta na-akpali nzaghachi, ma ọ bụ ebe ebumnuche bụ sistemu yana ụmụ irighiri etinye uche na-anọ n'okpuru 1%. Ọnọdụ ikpeazụ ahụ abụghị ọdịda imewe, ọ bụ ókè ala ahụ na-agbaba: peptides na-arụ ọrụ nke ọma na-agbada n'okpuru 1% bioavailability ọnụ, na ọtụtụ ọrụ a kọrọ na-anọdụ ala na a 0.4 ka 1.0% band, dị ka e depụtara na pharmacokinetic ókè nke nnyefe peptide ọnụ. Calcitonin bụ ihe a na-atụ anya ya, mmemme ọnụ sistemu nke na-ewepụghị mmanya ahụ, A na-enyocha ya na nyocha nke ọdịda calcitonin.

Ntugharị igodo: Họrọ ọnụ ọnụ mgbe ebumnuche bụ mpaghara na mkpughe abụghị nke kachasị mkpa. Debe njikwa injectable mgbe ihe mgbaru ọsọ bụ sistemu yana akụkụ nke etinye uche ya nọdụrụ ala 1%. Ọ bụrụ na nke ọ bụla dabara, azịza ziri ezi bụ ụzọ dị iche ma ọ bụ usoro dị iche, ọ bụghị mmemme ọnụ mmanye.

Ogo na usoro nyocha nke na-eme ka atụnyere ma ọ bụrụ na ọ ziri ezi

Nkwukọrịta ntunyere dị mma ka ngwugwu nyocha dị n'azụ ya. Otu nkwụsi ike na-egosi ntọala nke na-akọwapụta onye na-aga ọnụ bụ ihe na-eme ka nchịkwa injectable bụrụ njikwa ziri ezi: na-enweghị oke nrụgide matrix, abụọ datasets na-akọwa dị iche iche ụmụ irighiri ihe dị iche iche n'okpuru ọnọdụ dị iche iche na enweghị ntụnyere ejide. Ọnụ ego nke ICH Q1A(R2) matriks na-anwale nrụgide na-ekekọrịta ntọala maka mmebi mmanye, na FDA endotoxin ịgba mgbakọ na mwepụ nnabata-uru uru USP na-agbatị ya na nchekwa na nha nha., ya mere onye nleba anya nwere ike wepụta ọnụọgụgụ ọ bụla na usoro karịa nchịkọta.

Nchọpụta anyị: MOL Mgbanwe bụ ngwakọta organic-kemistrị na bayoloji R&D nzukọ na-emepụta omenala na peptides gbanwetụrụ n'okpuru klaasị 100 ọnọdụ ime ụlọ dị ọcha na HPLC, Nyocha MS na ịmụ nwa. Ngwungwu ahụ na-akwado nkwụsi ike na-egosi ọrụ nke mmemme mmepe peptide ọnụ chọrọ, na enwere ike iji ya kọwaa njikwa injectable n'otu ụzọ ahụ, nke bụ ihe na-eme ka ntụnyere ahụ bụrụ ihe ziri ezi kama ịbụ naanị ihe yiri ya.

Ajụjụ a na-ajụkarị

Bụ peptide ọnụ na-agbanwe agbanwe yana njikwa injectable?

Ọ bụghị na ike nke AUC naanị. Ntụle otu dose nke akara Mycapssa na-egosi mkpughe zuru oke megide njikwa injectable, ma ọnụ ọgụgụ kasị elu na-agba ọsọ 33% gbadaa wee bịarute Peptides sịntetik na 1.67 ka 2.5 awa karịa 0.5 awa. Mgbanwe mgbanwe na-atụgharị na ihe ojiji ụlọ ọgwụ dabere na ya: ọgwụgwọ chọrọ ngwa ngwa, elu elu anaghị eje ozi site na profaịlụ na-adaba ma na-egbu oge.

Enwere ike iji onye na-achọ ọnụ tụnyere nke ọma ma ọ bụrụ na bioavailability ya dị n'okpuru 1%?

Ee, mana ọ bụ naanị na mkpughe sistemu dakọtara karia ka usoro ọgwụgwọ dabara adaba. Nyochaa oke-PK na-etinye peptides ọnụ ugbu a na a 0.4 ka 1.0% bioavailability band, ya mere a na-agbaji ogwe aka ọnụ 10 ka 100 ugboro elu iru otu ekesa ọkwa. Mmụba nke ahụ bụ nsonaazụ mgbakọ na mwepụ nke ụzọ ahụ, ma ọ bụ ya mere ngbanwe dose maka peptides ọnụ na-aghọ nsogbu siri ike. Ihe gbasara

Kedu ihe kpatara eji eji ọnụ peptides na-ebu ọnụ?

N'ihi na nri anaghị adị ngwa ngwa, o nwere ike wepu ya. Ihe achọrọ na-ebu ọnụ ugbu a gafee usoro peptide ọnụ na-egosipụta nchọta na-agbanwe agbanwe na iji nri were were na-ebuga bioavailability gaa na efu efu., na ndekọ data mmetụta nri nke Mycapssa label dị ka a 90% mbelata ma ọnụego na oke nke absorption.

Kedu ụzọ mmebi iwu kacha mkpa maka peptide ọnụ?

Oxidation, deamidation, hydrolysis na nchịkọta bụ ụzọ anọ nke kemịkalụ na nke anụ ahụ, na ICH Q1A(R2) Matriks na-anwale nrụgide bụ nyocha nke edobere maka ịmanye ha n'oge. Onye na-azọ ọkwa ọnụ na-eburu otu ụzọ njikwa injectable ya agaghị ezute: proteolysis nke eriri afọ, ebe enzymes digestive na-awakpo peptide tupu ya erute ebe nnabata.

Ọ ka bara uru ịchụso mmepe peptide ọnụ?

Maka ụmụ irighiri ihe dị n'okpuru ọnọdụ dosing akọwapụtara, ndekọ akwadoro kwuru ee: Oral semaglutide ruru 0.795% bioavailability zuru oke na nyocha PK ọnụ nke semaglutide ọnụ. The counterweight bụ ezigbo. Nyocha nke ọdịda calcitonin na-edepụta mmemme na-adị ndụ, na nleba anya nke mgbagwoju anya nke mbipụta-biashụnanya caveat pụtara akwụkwọ na-akọ banyere ihe ịga nke ọma, Ya mere, a naghị amata ọnụ ọgụgụ isi n'ezie site na ọrụ bipụtara.

Mmechi

Mkpebi ọkwa ọkwa na-agbanwe agbanwe n'ofe ntụnyere. Njikwa injectable na-emeri na nkwụsi ike nke dose yana na ihe akaebe atụnyere, n’ihi na a na-atụ mkpughe ya ma kọwaa ụkpụrụ ntụaka ya. Onye na-azọ ọkwa ọnụ na-emeri ebe ebumnuche bụ mpaghara ma ọ bụ windo ọgwụgwọ obosara, na ọ dị mfe iji mara mgbe ngwaahịa na-emebi emebi mara na nyocha. Nkwụsi ike na ikike na-anọgide na-abụ njirisi abụọ ebe ụzọ ọnụ na-ebu ibu ihe akaebe dị arọ.

Nke ahụ na-enye iwu mkpebi. Họrọ ọnụ mgbe ebumnuche bụ mpaghara ma ọ bụ mpio obosara yana ngwugwu ihe akaebe zuru oke. Họrọ njikwa injectable mgbe windo dị warara, A na-ebute arụmọrụ kacha elu, ma ọ bụ ụmụ irighiri ihe etinye uche na ya na-anọdụ ala n'okpuru 1%, Uko ụlọ sara mbara nke klaasị akọwara na ntụle ala-PK. Ebe ọ dịghị dabara, gbanwee ụzọ ma ọ bụ ụkpụrụ kama ịmanye ntụnyere ahụ. Gụọ ntụnyere otu dose akara Mycapssa dị ka akara maka ihe dabara na mkpughe ya na a 33% obere Cmax na emesia tmax chọrọ n'ezie, ma were akwụkwọ nleba anya nke mgbagwoju anya - nhụsianya anya dị ka ịdọ aka ná ntị megide ịgụ akwụkwọ dị ka bọọdụ dị ọcha.. Mmepụta Peptide

Mmasị azụmahịa: MOL Mgbanwe na-enye njikọ peptide na ọrụ nyocha, ya mere ọ nwere mmasị azụmahịa na ụkpụrụ àgwà peptide. Edemede a bụ ihe teknụzụ maka otu mmepe, ọ bụghị ndụmọdụ ahụike.

Ọ bụrụ na ị na-atụ onye nyocha ọnụ, malite site na ntule ikike nka nka wee rịọ ngwungwu akwụkwọ: data nyocha na akwụkwọ ịmụ nwa maka ọrụ peptide ị na-enyocha.