 |
| |
 |
Anti - Ulcerative
- Potency as per request |
|
 |
Omeprazole
EC Pellets |
|
Lansoprazole EC Pellets |
|
Esomeprazole Magnesium
EC Pellets |
|
Pantoprazole EC Pellets |
|
Mesalazine Pellets |
|
| |
|
Anti fungal |
|
|
|
Itraconazole
Pellets 22.5% |
|
| |
|
Immuno Suppresants |
|
|
|
Tacrolimus
Pellets |
|
Sirrolimus (Rapamycin)
Pellets - Under Development |
|
Mycophenolate Mofetil
Pellets - Under Development |
|
| |
| Specifications |
| We are manufacturers
of Pellets / Granules. The semi finished formulations
are based on specialized coating technology and
are intended for the following release patterns: |
|
Enteric
Release |
|
Sustained Rrelease |
|
Delayed Release |
|
Extended Release |
|
Controlled Release |
|
| The release
profile of the products is customized to suit requisite
specification. Similarly the mesh sizes offered
are in the range of 12-24 mesh. The Products comply
with Specifications laid down by the following Pharmacopoeias
IP, EP ,USP 23 / USP 29 and CP 2005. |
| |
| Drug Master
Files |
| The Drug master
files for the following Products are available in
both the EDMF format and USDMF format |
|
Omeprazole
Pellets |
|
Lansoprazole Pellets |
|
Itraconazole Pellets |
|
The DMF file
for Omeprazole Pellets 8.5% is submitted to the
USFDA and is awaiting review.
The EDMF file for Omeprazole Pellets 8.5% is submitted
with the National Authorities is Greece and Romania
and is awaiting review.
Omeprazole Pellets 8.5% BA/BE Studies are under
process. |
| |
| Development
and Targated Area for Deliveries |
Murli Krishna
Pharma Pvt Ltd (MKPPL) manufactures formulations
based on specialized coating techniques. The delivery
systems targeted are enteric release, extended release,
delayed release, sustained release and controlled
release.
MKPPL supplies semi-finished forms of anti-ulcer
ants for the regulatory market as well as the non-regulatory
market. The company plans to target other molecules
that could be administered in novel dosage forms
such as sustained / controlled release types or
micro / nano encapsulated forms.
Omeprazole, Lansoprazole, Esomeprazole, Pantoprazole
have as anti ulcerants revolutionized ulcer treatment
by directly blocking the proton pumps responsible
for the secretion of the acid. These molecules tend
to be sensitive to stomach acid. The formulation
is designed so that the drug is released in the
small intestine.
MKPPL's product range includes E.C. Pellets of Omeprazole,
Lansoprazole, Esomeprazole , Pantoprazole and Anti
Fungal Itraconazole, Pellets, Deodorized Pellets
of Fish Oil strong in Omega 3 Fatty Acids. |
| |
| Enteric Coating |
| Release is controlled
through a process known as enteric coating wherein
the formulation contains a polymer that is resistant
to the stomach acid. The selection of the type of
polymer and its molecular weight requires in depth
study. The polymer selected should be non-infringing,
as patents tend to be strict in terms of use of
excipients. |
| |
| Binders |
| MKPPL uses the aforementioned
process to choose polymers. They experiment with
novel binders that have been isolated from natural
sources. MKPPL aims to conduct more extensive studies
and file for a type III DMF. MKPPL's objective is
get these excipients approved in the regulatory
market which will help them to overcome the patents
covering certain key excipients. |
| |
| Omeprazole Proton
Pump Inhibitor |
Omeprazole is a widely
used proton pump inhibitor that is used in the treatment
of peptic ulcers. The drug commands a market size
of $7 billion and is marketed as an enteric release
formulation.
The product is offered as a semi-finished formulation
in a pelletized form. The API is manufactured under
a strict control with stringent specifications on
the impurity profile. The polymers used are specifically
chosen and are non-infringing. The pellets are offered
in the strengths of 9.0%, 8.5% and 7.5%. The product
can also be offered in a pellet size suitable for
use in a suspension. |
| |
| Esomeprazole |
| Esomeprazole is the chiral
form of omeprazole. The product is also manufactured
as enteric coated pellets. The API is manufactured
under MKPPL's control and has a low impurity profile.
MKPPL is currently developing a non-infringing process
for API and pellets. |
| |
| Lansoprazole Proton
Pump Inhibitor |
Lansoprazole is a second-generation
proton pump inhibitor. The API used for manufacture
is synthesized using a non-infringing route. The
use of non-infringing excipients and aqueous coatings
makes it aptly suitable for the regulatory market.
The semi-finished dosage form is available in the
same strengths as omeprazole and is intended for
use in capsule as well as in suspension. |
| |
| Itraconazole Pellets |
| We have manufactured Itraconazole
pellets containing 22% active substance using a
technology that involves the use of aqueous media
in the drug layering as well as coating. We can
also manufacture micro pellets using the same technology
for use in suspension. |
| |
| Microencapsulation |
Microencapsulated DHA
and EPA are under development. The microencapsulated
omega III fatty acids are used in the treatment
of arthritis and are extracted from fish oil.
Omega III fatty acids emit an unpalatable odor that
makes the formulation distasteful. Micro encapsulation
effectively masks the odor. Micro encapsulation
also minimizes the oxidation of the double bonds
present in the fatty acids. This formulation is
specifically designed for solid and liquid dosage
forms.
The semi-finished formulations are designed for
solid as well as liquid dosage forms. The semi-finished
formulations are offered as conventional sized pellets
(16-18 mesh or 18-22 mesh) or as micro or nano encapsulated
form. |
| top |
| This
website is not and should not constitute an offer
for sale in territories where it is not permitted
by Patent Law. |
