Thuc phun m

1- Trnh by nh ngha, -u nh-c im, phn loi 2- Trnh by -c thnh phn cu to 3- Phn tch -c cc yu cu chnh trong xy dng cng thc thuc phun m 4- Trnh by -c k thut bo ch 5- Nu -c yu cu kim tra cht l-ng.
1

i-i c-ng v thuc phun m 1. nh ngha: Thuc phun m (aerosol, kh dung) - Cp ng trong cc bnh chu p lc (kh nn, kh ha lng) - -c phun ra d-i dng cc tp rt mn (th-ng < 50 Qm) R (L) - DD, HD, NT, b t

u nh-c im

- -u im:
S dng thun tin, d dng hn ch -c cc tc ng bt li ca MT Hn ch au cho BN Tng SKD do KTTP nh, din tch tip xc ln Phn liu chnh xc (van nh liu)

u nh-c im

- Nh-c im:
- cn h-ng dn s dng ng - Bao b c bit - Bo ch, sn xut i hi thit b ring. - S dng cht y CFCs gy ph hu tng ozon. - Cc cht y hydrocarbon d chy n.

Phn loi Theo -ng dng: . Dng ti ch trn da, nim mc, cc hc ca c th nhtai, mi, d-i l-i, trc trng, m o, . Dng xng ht qua -ng h hp (inhaler). Theo cu trc h cha trong bnh: DD, HD, NT, bt siu mn, ng kh Theo thit b, dng c phun m.

Dng theo -ng xng ht

Dng theo -ng qua da

II-THNH PHN THUC PHUN M

1. CHT Y

2. Bnh cha

3. Van

4. u phun

II-THNH PHN THUC PHUN M

Kh nn (nito, carbon dioxyd, dinito oxyd). p lc nn gim dn, l-ng thuc phun k n nh, bnh ng ln 1. CHT Y Kh ha lng: gi -c p sut hng nh, chnh xc v liu v KTTP phun

Cht y 11 12 114 142 152

Tn ho hc Triclomonofluormethan Diclo difluormethan Diclo tetrafluor ethan Monoclo difluor ethan Difluor ethan

p sut hi (atm, 21oC) 0,91 5,78 1,87 2,36 5,19

tan trong n-c (%) 0,009 0,008 0,007 0,054 0,17

t c, tr v HH, khng d chy. Dng phi hp to p sut hi thch hp.

Cht y A 108 A 31 A 17 A 46

Tn ho hc Propan Isobutan Butan Propan/Isobutan

p sut hi (atm, 21oC) 7,34 2,11 1,16 3,12

T trng (21oC) 0,509 0,564 0,585 0,556

- u im: r, khng gy hi kh quyn, - Nh-c im: d chy n, c th khc phc bng cch dng hn hp vi cht y fluorocarbon.

Ngun: Pharmaceutical preformulation & formulation.2009

II-THNH PHN THUC PHUN M Bnh thy tinh bc polyme: ng p sut thp Bnh thp khng g: k b n mn, chu p sut cao, gi thnh cao Bnh thp m thic, bnh nhm trng vecni hoc polyme: tr v HH, nh, r Chu -c p sut cao, tr v HH v tc dng DL, gi r .

2. Bnh cha

II-THNH PHN THUC PHUN M

Van phun lin tc (spray valve)

3. Van Van nh liu (meter valve)

y kn v phn phi thuc .

4. u phun
- u phun c tc dng to ra cc tiu phn t-ng i nh bng cch cho hi y qua cc l h. - Hnh dng u phun, kch th-c l m, ming phun, bn cht ca cht y nh h-ng ti c im ca ch phm: to bt xp hay phun m phn tn. - Mt s loi u phun th-ng dng: . u phun m: c 1 - 3 l m, -ng knh 0,4 - 1 mm . u phun to bt xp: l thot kh rng 1,78 - 3,81 mm . u phun dng cho thuc bn rn (m, gel) . Cc u phun c bit: C hnh dng, cu to p ng -a thuc n v tr nh- yt hu, mi, tai, rng ...

spray

aerosol

Iii-thit k cng thc thuc phun m Xy dng cng thc tpm h dung dch + Chn DM c kh nng ho tan DC v cht y. + Cht y: . T l cht y: dung dch to ht mn hay th tu thuc vo t l cht y trong thnh phn ch phm. . Cht y khng t-ng tc, t-ng k vi cc thnh phn c trong ch phm. . c tnh thp.

Thnh phn
Hot cht Dung mi Cht lm tng tan Cht chng oxy ho Cht lm thm Cht y (ring hoc hn hp)

Cht in hnh
Rn, lng, kh ho tan -c Ethanol, glycol (PG, PEG), n-c Din hot Acid ascorbic Tinh du S 12, 12/11, 12/114, 12/11/114

Thnh phn
Nitroglycerine Dichlorodifluoromethane Dichlorotetrafluoroethane Cht lm thm, cht bo qun, dung mI v 0,41

L-ng (mg)
DC 10,66 16,01 22.92 Total: 50 mg

Vai tr

Cht y Cht y

BB nhm, van nh liu 50mg/liu

Thnh phn
Hot cht Dung mi Cht lm tng tan Cht chng oxy ho Cht bo qun Cht y (ring hoc hn hp)

Cht in hnh
Rn, lng, kh ho tan -c Ethanol, isopropanol, glycol (PG, PEG), isopropyl ester, n-c Din hot Acid ascorbic Paraben Isobutan,propan/butan, propan/isobutan, cht y 12...

Thnh phn Isoproterenol Acid ascorbic Alcol ethylic Dichlorodifluoromethan Dichlorotetrafluoroethan Cht lm thm, cht bo qun, dung mI v

Amount (g) 0.25 0.01 33.00 33.37 33.37 100.00

Type

Iii-thit k cng thc thuc phun m Xy dng cng thc tpm h dung dch Ch :
-AH

ca HHDM, cht y n ha tan, n nh

DC
-KTTP

v sc cng b mt cht lng -Kh nng gy kch ng ca cht ph

-Cht

ph tng tan phi chuyn ha, k b l-u gi mng nhy ca -ng HH.

Xy dng cng thc tpm h hn dch

1. Hm m ca thnh phn c trong ch phm. 2. Kch th-c tiu phn phn tn: trong khong 1- 5 mcm. i vi thuc dng ngoi, KTTP trong khong 40-50 mcm. 3. tan ca d-c cht: ph hp 4. T trng d-c cht v cht y 5. Cht din hot v cht gy phn tn.

Thnh phn
Hot cht

Cht in hnh
Bt siu mn

Cht gy phn tn hoc cht Sorbitan trioleat, lecithin v dn din hot Cht y (ring hoc hn hp) cht ca lecithin, acid oleic, alcol oleic, ethanol. S 12, 12/11, 12/114, 12/11/114

Thnh phn Epinephrine bitartrate (1 - 5 mcm) Sorbitan trioleate Cht y 114 Cht y12

L-ng (%) 0.50

Vai tr

0.50 49.5 49.5

Thnh phn Hp cht steroid Oleic acid Cht y11 Cht y12

Khi l-ng 8.4 mg 0.8 mg 4.7 g 12.2 g

Vai tr

Thnh phn Salbutamol Acid oleic Cht y11 Cht y 12

Khi l-ng 20 mg/ l, cha 200 liu, mi liu 100 mcg.

Vai tr

Bit d-c cyclohanler: vin nang cng cha 200 mcg salbutamol, km theo dng c xng ht.

Thnh phn Formoterol fumarat 2H2O Budenosid Lecithin Cht y 11 Cht y 12 6 mcg

Khi l-ng

Vai tr

100 mcg & 200 mcg 5,562 mg 18 750 mcg 48 125 mcg

Xy dng cng thc tpm h nh t-ng

Thnh phn
Hot cht Cht nh ho Cc thnh phn khc Cht y (ring hoc hn hp)

Cht in hnh
Ho tan trong acid bo, du thc vt, glycol X phng ca acid bo hoc x phng amin, polysorbat... Cht lm trn, chng dnh, bo qun, lm thm... 12/114 (ch dng khi -c php), hydrocarbon, 22/152a, 22/142b, 152a/142b.

Thnh phn
Glycol hoc t d-c thn du Cht nh ho (th-ng dng: glycerin monostearat) Cht y hydrocarbon hoc propelant

T l %
91,0-92,5 4,0 3,5-5,0

Thnh phn
Hot cht Cht din hot N-c Ethanol Isobutan

T l %
khng qu 25 0,5-5,0 28-45 15-20 3,0-5,0

Thnh phn Acid mirystic Acid stearic Alcol cetylic Lanolin Isopropyl mirystat Triethanolamin Glycerin Polyvinyl pyrolidon N-c tinh khit 1,33 5,33 0,50 0,20 1,33 3,34 4,70 0,34 82,93

T l %

Vai tr

La chn cht y, bnh cha, van, u phun

- Cht y:
. Fluocarbon: ch dng cho TPM yu cu cht l-ng c bit nh- xng ht. . Hydrocarbon dng thch hp cho TPM c n-c trong TP. . Kh nn dng cho TPM dng ti ch. . Th-ng dng phi hp cht y p ng -c cc yu cu v t trng, p sut hi v hn ch chy n - Tu theo yu cu v c im s dng ca ch phm TPM m chn bnh, van, u phun cho thch hp.

Iii-k thut bo ch aerosol

1. Pha ch thuc np vo bnh S dng KTBC chung i vi DD, HD, NT thuc. 2. ng np thuc v cht y vo bnh thuc - Ph-ng php ng p sut: . Np thuc vo bnh cha . t van, vng m vo ming bnh, ng kn . Np kh y qua van vo bnh d-i p sut cao . Gn u phun - Ph-ng php ng lnh . Thao tc nhit thp, th-ng dng tuyt carbonic . Np thu c v kh ho lng vo bnh . t van, ng kn, t gn u phun.

V tr t nang cng cha d-c cht

Nghin cu bt xng ht cha beclomethason

1. Thnh phn: Beclomethason dipropionat bt siu mn, lactose kch th-c < 38 mcm, PEG 400, 3000 v 6000. 2. Ph-ng php: Beclomethason dipropionat bt siu mn -c trn u vi lactose v PEG phun sy. ng nang cng s 2, cha 29 1 mg hn hp bt, t-ng ng 425 5 mcg DC. 3. nh gi:
. Kch th-c tiu phn, t trng bt, hm m . Tnh cht: dng pp knh hin vi in t ct lp, phn tch nhit vi sai, ph nhiu x tia X, ph hng ngoi. . nh l-ng DC bng HPLC, NC n nh...

iV- kim tra cht l-ng Tpm

1. Kim nghim nguyn ph liu - Cht y - Van (van nh liu), nt bm, ng nhng - Bnh cha 2. Kim tra trong qu trnh sn xut 3. Kim nghim thnh phm: . bt la v chy . Tnh cht vt l: p sut hi, t trng, hm m... . chnh xc phn liu, kch th-c tiu phn.. . Ch tiu sinh hc, hot lc...