REFRANCES:
1. www.pubmed.com :
(1) Garg ,A., Gupta ,M., Bhargava ,H.N.. (2007). Effect of formulation parameters on the release characteristics of propranolol from asymmetric membrane coated tablets. European Journal of Pharmaceutics and Biopharmaceutics. 67(3), 725-731.
(2) Närvänen ,T., Lipsanen ,T., Antikainen ,O., Räikkönen ,H.,Yliruusi ,J.. (2008). Controlling granule size by granulation liquid feed pulsing. International Journal of Pharmaceutics. 357(1-2), 132-138.
(3) Ende ,T.a.m., Moses ,K., Carella ,j., Gadkari ,A., Graul ,W., Otano ,L., Timpano ,J. .( 2007). Improving the Content Uniformity of a Low-Dose Tablet Formulation Through Roller Compaction Optimization. Pharmaceutical Development and Technology. 12(4), 391 – 404.
(4) Alkhatib ,H.S., Aiedeh ,K.M., Bustanji ,Y., Hamed ,S., Mohammad ,M.K., Alkhalidi ,B., Najjar ,S.. (2008). Modulation of buspirone HCl release from hypromellose matrices using chitosan succinate: Implications for pH-independent release. European Journal of Pharmaceutics and Biopharmaceutics.
(5) Brodka-Pfeiffer ,K., Langguth ,P., Grass ,P., Häusler ,H.. (2003). Influence of mechanical activation on the physical stability of salbutamol sulphate. European Journal of Pharmaceutics and Biopharmaceutics. 56(3), 393-400.
(6) El-Sabawi ,D., Price ,R., Edge ,S., Young ,P.M.. (2006). Novel temperature controlled surface dissolution of excipient particles for carrier based dry powder inhaler formulations. 32(2), 243-51.
(7) Bacher ,C., Olsen ,P.M., Bertelsen ,P., Sonnergaard ,J.M.. (2008). Compressibility and compactibility of granules produced by wet and dry granulation. International Journal of Pharmaceutics. 358(1-2), 69-74.
(8) Bock ,T.K., Kraas ,U.. (2001). Experience with the Diosna mini-granulator and assessment of process scalability. European Journal of Pharmaceutics and Biopharmaceutics. 52(3), 297-303.
(9) Badawy ,S.I., Menning ,M.M., Gorko ,M.A., Gilbert ,D.L. (2000). Effect of process parameters on compressibility of granulation manufactured in a high-shear mixer. International Journal of Pharmaceutics. 198(1), 51-61.
2. advanced pharmacetics: physicochemical principle . cherng-ju Kim.publisher,CRC press.ISBN:0849317290.
3. ansels pharmaceutical dosage form and drug delivery system.loyd V.allen Howard C.Ansel Nicholas G.povich.puplisher:Lippincott William &wilkin.8 th edition.ISBN:0781746124.
4. physical pharmacy , Alfred martin ,ph.d. .
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Influence of manufacturing process on physical and flow characteristic and compatibility of powder
1. Influence of manufacturing process on
physical and flow characteristic and
compactibility of powder
Ghazwa shawash
2. Influence of manufacturing process
on physical characteristic
What is manufacturing process?
We have a lot of manufacturing process
according to the type of drug we deal
with; solid or liquid ,but in general
manufacturing process (when we talk a
bout solid drug) is blending ,
compression , temperature , granulation
, drying ,coating , milling , carrying the
material from one place to Another.
3. Influence of manufacturing process
on physical characteristic
What is physical characteristic?
Physical characteristic of the drug is the
dissolution ,disintegration, hardness
thickness , content uniformity , particle
size distribution , water content
, organic liquid content , Friability .
4. Influence of manufacturing process
on physical characteristic
1)In pharmaceutical preparation we use coating
for modifying the drug release , coating can be
achieved by precipitation. Propranolol tablets
are coated with a cellulose acetate and
glycerin , in a study they found that modifying
preparation parameters like temperature of
the precipitation path and polymer
concentration, pore former concentration give
us Asymmetric membranes and a desired
release rates can be obtained (A zero order
release of propranolol was obtained from the
coated tablets) .the release was independent
of the pH and the rate of agitation of the
dissolution medium .
5.
6. Influence of manufacturing process
on physical characteristic
In pharmaceutical industries we prefer
granulation instead of direct
compression , so many studies are done
for manufacturing processing of
granulation, they study the influence of
various granulation parameters and
formulations on granule size
distribution.
7.
8. Influence of manufacturing process
on physical characteristic
1)they studied the influence of various
granulation parameters ; they found that
a.Increasing inlet air humidity and
b.granulation liquid feed rate resulted in
greater median granule size as expected but
when a. liquid feed Pulsing is used they found
that median granule size decreased clearly.
This effect was strong, especially with a. high
inlet air humidity and b. rapid liquid feed rate
processes, Granulation liquid feed pulsing is
an effective way to modify the particle size of
final granules
9. Influence of manufacturing process
on physical characteristic
We use granulation for many purpose one of
them is to over come segregation problem,
but we must control granule size so that we
will not face the same problem. in the study
they found that the a. new roller compaction
and b. milling conditions reduced the
potential for segregation by minimizing the
granulation potency variability as a function
of particle size and so Improving the content
uniformity of a low-dose tablet formulation
10.
11. Influence of manufacturing process
on physical characteristic
Chitosan succinate was proved effective in modulating
buspirone HCl release from HPMC matrices for pHindependent release through ionic complex
formation.
1) In the study they found that The extent of the
interaction of Chitosan succinate and buspirone HCl
was highest in wet mixtures and was found to be
dependent on the pH of the granulation liquid.
2) But when Chitosan succinate in high amount
(depending on the level and mode of incorporation)
was incorporated in buspirone HCl –containing
(HPMC) matrices, tablets using dry mixing and wet
granulation this modulating buspirone HCl release
from HPMC matrices for pH-independent release
through ionic complex formation
12. Influence of manufacturing process
on physical characteristic
Another manufacturing process is the
temperature dissolution, in the study they
found that novel temperature controlled
surface dissolution of excipient particles for
carrier based dry powder inhaler formulations
they found that at :
1) 30 degrees C ; the level of lactose fines was
reduced .
2) 35 degrees C, there was an increase in fine
particle fraction .
13. Influence of manufacturing process
on physical characteristic
1)In order to obtain the optimal particle size
distribution for pharmaceutical powders in dry
powder inhalers the particles have to be
micronized. In most cases the process of
micronisation is connected with a high input of
energy such as 1.feed pressure, 2.feed rate and
3.grind pressure ,which may induce disorder and
defects on the surface of the drug particles and as
a result changes in the crystallinity Consequently,
changes in the physical stability of the powders
may occur ; they studied that on salbutamol
sulphate , and found that the 1.feed pressure and
2.rate have negligible influence on the powder
quality but the 3.grind pressure is of utmost
importance with respect to particle size distribution
and the physical powder stability
14. Influence of manufacturing process
on flow characteristic
What is flow characteristic?
Ability of powder to flow on its own
gravity in the uniform way to the die to
get a tablet that has the desired weight
of excepient and drug.
15. Influence of manufacturing process
on flow characteristic
We say that pharmaceutical preparation
prefer granulation instead of direct
compression , but we have wet and dry
granulation , in the study they found
that Granules from both granulation
methods possessed an acceptable flow
characteristics .
16. Influence of manufacturing
process on flow characteristic
1)Many powders , because of their small size or surface
characteristic , are cohesive and do not flow well.
poor flow will often result in a wide weight variation
within the final product due to variable fill of tablet
dies , so to improve flow properties, granulation is
used , in the study they found that if we a. Increase
the granulation time ,b. the impeller speed c. and the
amount of binder all resulted in an increase in
granule size, whilst a. high fill ratios resulted in an
increased proportion of fines .
2)The speed of the chopper did not affect granule size
distribution for the formulations tested .
3)They found that larger scale machines, resulted in
granules which were smaller than those prepared in
the laboratory-scale equipment .
17.
18. Influence of manufacturing process
on compactibility of powder
What is compactibility?
compactibility is a synonym for
compressibility which is the measure of
the relative volume change of solid as a
response to a pressure change and it is
affected by porosity
19.
20. Influence of manufacturing process
on compactibility of powder
We say that we have tow types of granulation
wet and dry , in the study of effects of the
compactibility of granules produced by wet
and dry granulation The wet processed
granules showed in general larger
compression properties ;This was explained
as these granules were mechanically stronger
and had a higher initial porosity .
21. Influence of manufacturing process
on compactibility of powder
As we said before that porosity affect on
compressibility , in the study they found that
1)increasing moisture content of the
granulation and decreasing wet massing time
or impeller speed increased granulation
compressibility.
2)But increasing impeller speed and/or wet
massing time decreased granule porosity,
which led to decreased granulation
compressibility.