MC

MC TIU
TIU HC
HC TP
TP
1.

Nu c nh ngha, phn loi thuc nang.

2.

Ni c mc ch ng thuc vo nang.

3.

K c u, nhc im ca thuc nang.

4.

Vit c quy trnh bo ch nang mm theo 3

phng php: nhng khun, nh git v p
khun.

MC
MC TIU
TIU HC
HC TP
TP
5.

Trnh by c cch ch v nang cng v k

thut ng thuc vo nang.

6.

Nu c ch tiu cht lng v phng php

nh gi thuc nang.

7.

Trnh by c cc yu t nh hng n SKD

thuc nang v bin php nng cao SKD.

THUC
THUC NANG
NANG MM
MM

THUC
THUC NANG
NANG CNG
CNG

So snh nang mm v nang cng

Yu t

Nang mm (p khun)

Nang cng

C cht lm do
(glycerin, PG, sorbitol)

Khng c cht lm do

Rut

Lng, bt nho (i khi

rn)

Rn (i khi lng, bt
nho)

PP SX

To v v ng thuc
ng thi (v kn)

To v tch ri ng
thuc (np v thn ri)

Hnh dng v
a dng
kch thc

Gii hn

Cng ngh
SX

Lng

Rn

Bin thin
khi lng

1 3%

2 5% (/v my ng
nang hin i)

DUNG
DUNG DCH
DCH V
V NANG
NANG MM
MM
Gelatin: 35 45%

Khng c.

Tan trong cc dch sinh hc nhit c th.

Kh nng to mng tt.

Kh nng to gel tt.

bn gel: 150 250 g Bloom (rut c PEG:

cn bn gel cao hn).

nht: 25 45 mP.

St: 15 ppm.

DUNG
DUNG DCH
DCH V
V NANG
NANG MM
MM

Cht lm do: 15 20%

Glycerin: /v rut nang thn du.

Sorbitol c bit: /v rut nang cha nhiu PEG

(sorbitol khng tan trong PEG).
Sorbitol
40 - 55%
Sorbitol anhydrid 15 - 30%
Manitol
1 - 10%
T l cht rn
76%
nht (25oC)
300 cps
Khng b kt tinh li trong v nang.

DUNG
DUNG DCH
DCH V
V NANG
NANG MM
MM

Nc
Cc cht khc

T l glycerin/gelatin trong v nang

Glycerin/gelatin

ng dng

0,35

Vin nang cha dung dch du c v cng.

0,46

Vin nang cha dung dch du c v mm

do hn.

0,55 0,65

Vin nang cha dung dch du c thm cht

din hot hoc cht lng thn nc.

0,76

Vin nang c v c th nhai c.

Cc cht thm vo dung dch v nang mm

Cc cht c thm
vo khi gelatin
Nhm I
Methylparaben/
Propylparaben (4/1)
Cht mu
Titan dioxyd
Ethyl vanilin
Tinh du
Nhm II
ng knh
Acid fumaric

Nng
(%)
0,2
v
0,2 1,2
0,1
0-2
05
01

Mc ch

Bo qun
To mu
Lm c
iu hng
iu hng
iu v (vin nhai)
H tr ho tan, gim phn
ng gelatin + aldehyd

CNG
CNG THC
THC NG
NG NANG
NANG MM
MM
Cht lng nguyn cht: thn du (du c).
Dung dch: DC ho tan trong cht mang:
- Du: du u tng, Miglyol 812 (trung tnh, triglycerid ca
acid bo c mch trung bnh).
- PEG: 400 600.
- Dung mi khc: khng lm phn hu hoc ho tan v gelatin
(dimethyl isosorbid, cht din hot, diethylen glycol monoethyl
ether).
Cc cht khc:
- Nc, ethanol: 5 10% tng tan.
- Glycerin: 1 4% gim s mt glycerin v vo rut.
- PVP: < 10% (kt hp vi PEG) tng tan hoc gim s
ti kt tinh DC.

CNG
CNG THC
THC NG
NG NANG
NANG MM
MM
Hn dch: DC phn tn trong cht mang:
- C th cha n 30% cht rn.
- C th c ung nng n 35oC gim nht.
- KTTP < 80 mesh trnh tc kim (colloid mill).
Cht mang:
- Hn hp du:
Du u tng + sp ong (4 10%) + lecithin (2 4%).
Gelified oil (Geloil
- PEG: 800 1000:
1000 10000:

SC).
cho hn hp mm
cho hn hp rn

- Glycerid c mch di + cht din hot (Gelucire

33/01).

CNG
CNG THC
THC NG
NG NANG
NANG MM
MM
Cc cht khc:
- Cht din hot: polysorbat, lecithin
- DC thn du/TD thn du: cht din hot c HLB = 10
Tng SKD

CNG
CNG THC
THC NG
NG NANG
NANG MM
MM
Tng k:
- Cc aldehyd: lm bin cht gelatin (cross-linking) Ko di
thi gian r.
- DC nhy cm vi nc c th b phn hu (Ranitidin) hoc b
hin tng a hnh (Terazosin).
- DC (c bit l loi d tan trong nc) d chuyn t rut vo
v hoc b gi trong ct thn du lm gim SKD.
- Khng nn c nhng cht tan trong nc c phn t lng
thp v cc cht d bay hi.
- Nc trong cng thc ng nang 5%.
- pH 2,5 7,5
- Hn hp ng nang phi chy lng nhit di 35oC.

Khun nhng nang mm

Thit b to nang nh git

S bo ch nang mm bng
phng php p khun
Cht mu
Cht bo qun
Cht ph khc

Nc

Ho tan/Phn tn
Gelatin

Ngm trng n

Glycerin/CLD
un nng

Ho tan
Lc

Thit b to nang p khun

Thit b to nang p khun

Thit b to nang p khun

Nang mm Vitagreen (Chungbo Health Co.LTD)

Natri chondroitin sulfat
Riboflavin butyrat
Pyridoxin hydroclorid

100 mg
6 mg
12 mg

- Oryzanol

5 mg

Fursultiamin

50 mg

Nicotinamid

50 mg

Calcium pantothenat

15 mg

Ergocalciferol

200 I.U

Cao ti (100:1)

10 mg

Du rum

21 mg

Du anh tho
Du u tng

6 mg
400 mg

Lecithin

16 mg

Sp ong vng

29 mg

Du da hydrogen ho

86 mg

Quinoline Yellow WS

Vin nang mm Pharmaton (Boehringer Ingelheim France)

Deanol bitartrat
26 mg
Cao nhn sm
40 mg
Retinol palmitat
2000 IU
Thiamin mononitrat
2 mg
Riboflavin
2 mg
Pyridoxin hydroclorid
1 mg
Cyanocobalamin
1 g
Acid ascorbic
60 mg
Nicotinamid
15 mg
Ergocalciferol
400 IU
DL -tocoferol acetat
10 mg
ng sulfat monohydrat
2,8 mg
Mangan sulfat monohydrat
3,1 mg
Km oxid
1,250 mg
Calci fluorid
0,420 mg
Kali sulfat
9 mg
Magnesi sulfat
50,7 mg
St sulfat
50 mg
Dicalci phosphat
352 mg

VIN NANG MM IBUPROFEN

Ibuprofen 200 mg
PEG 400 1000 mg
V nang:
Gelatin

40%

Sorbitol

Polyol 10%

Glycerin 10%
Nc ct 40%

VIN NANG MM GLYCERYL GUACOLAT,

PSEUDOEPHEDRIN HYDROCLORID,
DEXTROMETHORPHAN HYDROBROMID
Glyceryl
200 mg
Pseudoephedrin
30 mg
Dextromethorphan
10 mg
PEG
559 mg

guacolat

hydroclorid

hydrobromid

400

VIN NANG MM VITAMIN E

Vitamin E (D- tocopherol 1000 n v E/g) 400,00 mg

Du u tng

25,00 mg

V nang: gelatin, glycerin, nc, t dc mu.

VIN NANG MM METHYLCOBALAMIN

Methylcobalamin

0,5 mg

Du u tng, sp ong trng, lecithin

V nang:
Gelatin, Sorbitol Polyol, glycerin, titan dioxyd,
st oxyd , kali sorbat, nc tinh khit

VIN NANG MM CLOTRIMAZOL

Clotrimazol 100 mg
Du u tng 800 mg
Sp ong 40 mg
Lecithin 24 mg
V nang:
Gelatin, glycerin, nipagin, nipagin, nc tinh khit.

VIN NANG MM AMPRENAVIR

Amprenavir

150,00 mg

D- tocopheryl polyethylen glycol 1000 succinat (TPGS) 400,00 mg

Polyethylen glycol 400
V nang: gelatin, glycerin, sorbitol, nc, t dc mu.

240,00 mg

V NANG CNG
V nang: hn hp gelatin A (im ng in: pH 9, skin
gelatin) v B (im ng in: pH 4,7, bone gelatin).

c tnh gelatin:

bn gel (gel strength, Bloom strength): 150 280 g.

nht: dung dch 6,67% c nht 25 45 millipoise.

m: t 12 15%.

Cht mu (titan dioxyd).

Cht gy ng (thch).

Cht tng dai (methyl cellulose).

Nc.

V NANG CNG

V NANG CNG

PHNG PHP NG THUC VO NANG

Powder filling

Auger fill principle: dng phu: bt phi trn chy tt,

tnh ton cng thc.

Vibratory fill principle: c a nha c l rung.

Piston-tamp principle: dosing disk, dosator

Nonpowder filling

MY NG NANG TH CNG

NHNG
NHNG K
K THUT
THUT C
C BIT
BIT
In trn v nang.
Thay i tan ca v nang:
Hi formalin: kh kim sot.
Bao: salon, shellac, CAP, nha.

Tch ring nhng DC tng k: ng nang 2 giai

on.
ng cht lng v bt nho vo nang.

NANG CNG CHA CHT LNG

V
V NANG
NANG CNG
CNG C
C BIT
BIT
Nang HPMC (Vegicaps v nhng loi khc):
Trnh dng gelatin: oesophagebovine spongiform
encephalopathy (BSE), tn gio...
L tng /v DC b hng bi m (hm m trong nang
HPMC l 30 50%, thp hn nang gelatin).
HPMC khng cha nhng nhm chc d phn ng
ho hc vi DC nh gelatin.
t dnh vo thc qun hn.
D bao kim sot gii phng.
t
Nang starch hydrolysate: Capill

VIN NANG CNG PIROXICAM

Piroxicam (KTTP 60 m) 20 mg
Explotab 16 mg
Lactose 150 mg
Cellulose vi tinh th
Natri lauryl sulfat

150 mg

4 mg

Natri lauryl fumarat 2 mg

Magnesi stearat2 mg
ng nang s 1.

VIN NANG CNG PARACETAMOL

Paracetamol

500,00 mg

Sodium starch glycolate

30,00 mg

Aerosil 200 1,00 mg

Magnesi stearat

2,00 mg

Tinh bt (sy kh) 15,00 mg

ng nang s 0.

VIN NANG CNG ACYCLOVIR

Acyclovir (bt siu mn)
Natri lauryl sulfat
Tinh bt ng

3,00 mg

20,00 mg

Lactose monohydrat
Magnesi stearat
Ethanol

212,00 mg

52,00 mg

2,00 mg

VIN NANG CNG FENOFIBRAT

Fenofibrat (bt siu mn, 5 m) 100,00 mg
Natri lauryl sulfat

2,00 mg

Polyvinyl pyrolidon K-25 (100400 m) 100,00 mg

Nc tinh khit 1750,00 mg
Lactose monohydrat (100400 m) 114,28 mg
ng nang s 1.

VIN NANG CNG DOXYCYCLIN HYCLAT

Doxycyclin hyclat 122,00 mg
Avicel PH 102 26,00 mg
Tinh bt ng

4,00 mg

Natri lauryl sulfat

0,60 mg

Aerosil 200 0,60 mg

Magnesi stearat
ng nang s 3.

2,00 mg

VIN NANG CNG GEMFIBROZIL

Gemfibrozil 100,00 mg
Lactose khan

248,80 mg

Tinh bt ng

100,00 mg

Sodium starch glycolate

Povidone

25,00 mg

5,00 mg

Polysorbat 80

15,00 mg

Colloidal silicon dioxide

Magnesi stearat

5,00 mg

Nc tinh khit va
ng nang s 0.

1,25 mg

So snh SKD ca vin nn v nang mm ibuprofen

So snh SKD ca dung dch ung v nang mm

theophylin

So snh SKD ca vin nn v nang mm digoxin

nh hng ca KTTP DC n SKD ca nang cng

nh hng ca TD n n SKD ca nang cng

Phenytoin Phenytoin
(Lactose) (CaSO4)

Phenytoin
(Lactose)

nh hng ca TD trn n ho tan

ca nang cng

nh hng ca kiu my ng nang n

ho tan ca nang cng