Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Powerpoint Templates
Powerpoint Templates
TABLETS
Powerpoint Templates
Weighing
Screening
Milling
Mixing
Granulation
Blending
Compression
Packaging
Labeling
Powerpoint Templates
Powerpoint Templates
I.
IPQC Parameters to be
measured
Physical Parameters:
a. temp
b. time
c. particle size & texture
d. pressure mm H2O
e. weight
f. hardness
g. thickness & diameter
h. disintegration
i. dissolution ( % release)
j. friability
k. moisture content %relative humidity
Powerpoint Templates
Powerpoint Templates
Time
Operation
Dispensing
Sifting
Room
No.
Temp
C
%RH
Diff. press
(mm H2O)
23
42
2.0
48
1.8
Milling
2.0
Blending
Compression
Coating
Powerpoint Templates
signature
Compression Parameters
10
Parameter
Limit
Observation
Machine speed
Wt. of 20 tabs
12.00g +2 (11.76-12.24g)
Theoretical weight/tab
600mg
Hardness
Thickness (av. of 10
tabs)
Length
Width
Disintegration time
NMT 15 mins
Wt. variation
+ 3% of Av. Wt.
Powerpoint Templates
11
Wt. of 20 tabs
Wt. variation
DT
Powerpoint Templates
CAPSULES
12
Powerpoint Templates
13
Powerpoint Templates
14
% purity of gelatin
Viscosity of gelatin solution 25-45 millipoise
Bloom strength of gelatin solution 150-250 gm
Iron content NMT 15 ppm
pH of gelatin A=9; B=4.7
Film Thickness
Color, surface, appearance of empty shells
Temperature of hot air, for drying of shells
Length of Capsule & Body of the shell
Moisture content 12-15%
Powerpoint Templates
15
16
AVG WT
%DEVIATION
<300mg
10%
>300mg or more
7.5%
Powerpoint Templates
17
APPEARANCE:
Inspection of capsules checked with a standard strip
SORTING DEFECTS:
Electronic automated or manual inspection is made
to sort out & reject the defected caps.
Overprinting
Powerpoint Templates
LOZENGES
Powerpoint Templates
20
Powerpoint Templates
Powerpoint Templates
POWDERS
22
Powerpoint Templates
Types of
Powders
Effervescent powders
Dusting powders
Insufflations (Inhalers)
Dentifrice
Oral powders
23
Powerpoint Templates
24
Powerpoint Templates
25
Powerpoint Templates
1. Effervescent Powders:
sample powder in 250ml of water
produces
effervescence & dissolves in 12sec.
2. Dusting Powder:
color, texture, density, particle size,
flow, fluffiness, spread ability
3. Insufflations:
flow, particle size, density
4. Dentifrice:
abrasion, texture, particle size, color
26
Powerpoint Templates
27
Powerpoint Templates
28
Flow
Texture
Caking
Cohesion
Flow Speed
Granule attrition
Compaction & Relaxation
Dusting
Surface Friction
Aggregation
Air-entrapment
Granulation
Powerpoint Templates
Parameters Measured:
(principle-slicing, shearing, compaction)
speed of rotor blade
blade angle
path of blade
resistance in speed and angle
axial force
time distance travelled
Measured by a sensitive transducer attached to rotor
blades.
29
Powerpoint Templates
Summary
30
Oral Solid dosage forms are some of the most popular and
convenient methods of drug delivery.
REFERENCES:
1. WHO Guidelines For Good Manufacturing
Practices
2. Guidance For Industry: Nonsterile Dosage Forms; US
Dept. of health & human services
3. Manohar A Potdar; current-Good Manufacturing
Practices, Edn-2003.
4. D.H.Shah; standard operating procedures.
5. Satish Maliya; WHO Guidelines; Issue-Jan-1922;2011.
6. WHO public inspection report of finished product
manufacturing
31
32
THA
NK
YOU