| (
I ) Manufacturing Process : |
| The
manufacturing process of spray dried co-processed excipients
involves coprocessing at the preliminary stage to achieve
a mechanical and chemical bonding before spray drying
. The resultant slurry is spray dried to achieve the particle
size distribution and flow properties. |
| (
II ) Coprocessed Excipients - Grades |
i>RanExplo-
C
--Microcrystalline
Cellulose-USP/NF + Colloidal Silicon Dioxide-USP/NF +
Crospovidone-USP/NF
ii>RanExplo - S
--Microcrystalline
Cellulose-USP /NF + Colloidal Silicon Dioxide-USP/NF +
Sodium Starch --Glycollate
- USP/NF |
| (
III ) Advantages of Coprocessed Spray Dried Excipients. |
|
(A)
Technical Advantages :
----1. Improves Hardness
and Compressibility.
----2. Better Uniformity
than granulated inactives.
----3. - 60 # powder with
superior flow properties.
----4. Enhanced machine
tableting speed.
----5. Lower D.T.
----6. Consistent physical
parameters of excipients ensuring sturdy formulation.
----7. For Dispersible
formulation : For compliance with the uniformity of
dispersibility test
----with the standard practice
of granulation at # 40 ( 425 -500 micron ) results in
poor flow ----properties
thus reducing machine speed. With coprocessed excipients
the particle size of ----250
micron and less gives superior flow properties and enhanced
machine speed. Due to ----fine
particle size , formulation compliance with dispersibility
test of less than 710 micron is ----easily
achieved.
(B
) Commercial Advantages :
----1. No
need to maintain inventory of various excipients.
----2. Cost saving due
to elimination of wet granulation production steps.
----3. Productivity increase
due to increased machine speed.
----4. Cost saving in rework
expenses.
|
| (
IV ) Regulatory Affairs: |
| RanExplo-
C & RanExplo-S are being manufactured under license
from FDA as proprietary Excipients formulations. |
| (
V ) Project Report on Coprocessed excipients : |
| A
detailed study made for various formulation using RanExplo-C
& RanExplo-S is available on request. |
| (
VI ) About RanQ |
|
RanQ
has been in the business of manufacturing spray dried
Microcrystalline Cellulose and Sodium Starch Glycollate
for over 8 years now and has earned credibility of supplying
a quality product. RanQ customers today include almost
all major formulators in India. RanQ has a modern up-to-date
dedicated manufacturing facility for the manufacture
of excipients following cGMP , Schedule M ( for Inactive
bulk drugs ) and operating under FDA license.
RanQ
is therefore in the best situation to undertake the
development of coprocessed excipients to give substantial
advantage to the pharma industry.
|
