PRODUCT DEVELOPMENT TECHNOLOGY CONTROLLED RELEASE PELLETS GELATIN BEADS HOT MELT EXTRUSION MOUTH DISSOLVING FILM Umang Pharmatech Pvt. Ltd. STANDARD FEATURES : STANDARD FEATURES : STANDARD FEATURES : STANDARD FEATURES : Survey No. 146, H. No.1 (PT), Vasai Phata Highway Junction, Pelhar, Nh8, Vasai (E) - 401 208, Maharashtra (India). Tel. : (+91-22) 30018900 / 30018915 - 98, Mob. : (+91) 986 723 6594, Fax : (+91-22) 30018908 / 30018913 E-mail : [email protected], Website : www.umangpharmatech.com / www.umangpharmaceuticals.com www.umangpharmaceuticals.com Consists of Strip forming polymers, plasticizers, API, flavoring & coloring agent, etc. The delivery of drug via film, in-process onset of action, tailored to meet your requirements. Enhance efficiency & safety profile of medicament. Thin film is more stable, durable & quick dissolving than other forms. Thin film improves dose accuracy empowered to liquid / syrup dosage form. Ease of administration, beneficial for pediatric, geriatric & neurode generation disease. Dissolving without made of water like patients with disorders / nausea. Potential to develop sensitive drug targets. Sublingual film delivers a convenient, quick dissolving therapeutic dose. Drug contained by film, rapidly absorbs under the tounge to ensure compliance. From commercial prospective it offers extend revenue life cycle for drug patent expiring soon. Formulation development on a bench & pilot scale development. Short term accelerated physical stability studies before a full scale development program. Dossier preparation per product with scale up parameters for pilot and production scale. Contract manufacturing for the products in our GMP approved facility. Non-exclusive / exclusive arrangement to deliver treatments for your molecule. Complete Technology transfer from product to pilot to large scale production possible. Innovative, advanced IR & MR formulation & process technology. Dedicated project management with method development and validation. Internal Technology transfer from laboratory to pilot plant to commercial technology. Identifying the right key process parameters. Full scale production of at least three batches. Extended release (XR) or Long lasting (LA) allows for a decrease in dosing frequently. SR- specific amount of drug release at time intervals. Delayed or Enteric release formulation development is possible. API release at a specific point in body based on PH or other char. depending on drug profile. Drug release in the intestine formulated to release at a higher PH (more basic) or drug release in stomach (more acidic). Specific release pattern as per customer requirement can be developed. Short term accelerated physical stability studies before a full scale development program. Dossier preparation per product with scale up parameters for pilot and production scale. Contract manufacturing for the products in our GMP approved facility. Non-exclusive / exclusive arrangement to deliver treatments for your molecule. Complete Technology transfer from product to pilot to large scale production possible. Formulation development on bench scale. Bench & pilot scale development for your products. Heat sensitive molecules also can also be processed with special processing attachments. Dossier preparation per product with scale up parameters for pilot and production scale. Contract manufacturing for the products in our GMP approved facility. Technology transfer with equipment purchase & support if needed. Non-exclusive / exclusive arrangement to deliver treatments for your molecule. Hot melt pellets are also possible by attaching axillary equipments to the hot melt extruder. Complete Technology transfer from product to pilot to large scale production possible. Enhance solubility, bio for purely soluble drugs. Ability to incorporate taste masking. Broad selection of down stream process technology. Granules for end in solid dosage form, incl. CR delivery formulations. Tailored to meet your product requirements. Short term accelerated physical stability studies before a full scale development program. A range of proto type formulations are prepared under different process conditions. Analytical techniques applied as appropriate to determine formulation & process parameters. Improves the bio availability of purely water soluble & purely permeable compounds. Enhance dose uniformity of potent compounds and minimize variability. Reduce due time & benefit from a proven dosage form with stringent commercial success. Oil and pellets can be encapsulated by this technology. Gelatin and other core pellets can be made as per project needs. We work strictly under confidentiality agreements with customer defined time lines. Formulation development on a bench & pilot scale development. Tailored to meet your product requirements. Short term accelerated physical stability studies before a full scale development program. A range of proto type formulations are prepared under different process conditions. Analytical techniques applied as appropriate to determine formulation & process parameters. Dossier preparation per product with scale up parameters for pilot and production scale. Contract manufacturing for the products in our GMP approved facility. Technology transfer with equipment purchase & support if needed. Non-exclusive / exclusive arrangement to deliver treatments for your molecule. Customer defined pellets can be made with customer ingredients / actives . Complete Technology transfer from product to pilot to large scale production possible.
Transcript
1. PRODUCT DEVELOPMENT TECHNOLOGY CONTROLLED RELEASE PELLETS
GELATIN BEADS HOT MELT EXTRUSION MOUTH DISSOLVING FILM Umang
Pharmatech Pvt. Ltd. STANDARD FEATURES : STANDARD FEATURES :
STANDARD FEATURES : STANDARD FEATURES : Survey No. 146, H. No.1
(PT), Vasai Phata Highway Junction, Pelhar, Nh8, Vasai (E) - 401
208, Maharashtra (India). Tel. : (+91-22) 30018900 / 30018915 - 98,
Mob. : (+91) 986 723 6594, Fax : (+91-22) 30018908 / 30018913
E-mail : [email protected], Website :
www.umangpharmatech.com / www.umangpharmaceuticals.com
www.umangpharmaceuticals.com Consists of Strip forming polymers,
plasticizers, API, flavoring & coloring agent, etc. The
delivery of drug via film, in-process onset of action, tailored to
meet your requirements. Enhance efficiency & safety profile of
medicament. Thin film is more stable, durable & quick
dissolving than other forms. Thin film improves dose accuracy
empowered to liquid / syrup dosage form. Ease of administration,
beneficial for pediatric, geriatric & neurode generation
disease. Dissolving without made of water like patients with
disorders / nausea. Potential to develop sensitive drug targets.
Sublingual film delivers a convenient, quick dissolving therapeutic
dose. Drug contained by film, rapidly absorbs under the tounge to
ensure compliance. From commercial prospective it offers extend
revenue life cycle for drug patent expiring soon. Formulation
development on a bench & pilot scale development. Short term
accelerated physical stability studies before a full scale
development program. Dossier preparation per product with scale up
parameters for pilot and production scale. Contract manufacturing
for the products in our GMP approved facility. Non-exclusive /
exclusive arrangement to deliver treatments for your molecule.
Complete Technology transfer from product to pilot to large scale
production possible. Innovative, advanced IR & MR formulation
& process technology. Dedicated project management with method
development and validation. Internal Technology transfer from
laboratory to pilot plant to commercial technology. Identifying the
right key process parameters. Full scale production of at least
three batches. Extended release (XR) or Long lasting (LA) allows
for a decrease in dosing frequently. SR- specific amount of drug
release at time intervals. Delayed or Enteric release formulation
development is possible. API release at a specific point in body
based on PH or other char. depending on drug profile. Drug release
in the intestine formulated to release at a higher PH (more basic)
or drug release in stomach (more acidic). Specific release pattern
as per customer requirement can be developed. Short term
accelerated physical stability studies before a full scale
development program. Dossier preparation per product with scale up
parameters for pilot and production scale. Contract manufacturing
for the products in our GMP approved facility. Non-exclusive /
exclusive arrangement to deliver treatments for your molecule.
Complete Technology transfer from product to pilot to large scale
production possible. Formulation development on bench scale. Bench
& pilot scale development for your products. Heat sensitive
molecules also can also be processed with special processing
attachments. Dossier preparation per product with scale up
parameters for pilot and production scale. Contract manufacturing
for the products in our GMP approved facility. Technology transfer
with equipment purchase & support if needed. Non-exclusive /
exclusive arrangement to deliver treatments for your molecule. Hot
melt pellets are also possible by attaching axillary equipments to
the hot melt extruder. Complete Technology transfer from product to
pilot to large scale production possible. Enhance solubility, bio
for purely soluble drugs. Ability to incorporate taste masking.
Broad selection of down stream process technology. Granules for end
in solid dosage form, incl. CR delivery formulations. Tailored to
meet your product requirements. Short term accelerated physical
stability studies before a full scale development program. A range
of proto type formulations are prepared under different process
conditions. Analytical techniques applied as appropriate to
determine formulation & process parameters. Improves the bio
availability of purely water soluble & purely permeable
compounds. Enhance dose uniformity of potent compounds and minimize
variability. Reduce due time & benefit from a proven dosage
form with stringent commercial success. Oil and pellets can be
encapsulated by this technology. Gelatin and other core pellets can
be made as per project needs. We work strictly under
confidentiality agreements with customer defined time lines.
Formulation development on a bench & pilot scale development.
Tailored to meet your product requirements. Short term accelerated
physical stability studies before a full scale development program.
A range of proto type formulations are prepared under different
process conditions. Analytical techniques applied as appropriate to
determine formulation & process parameters. Dossier preparation
per product with scale up parameters for pilot and production
scale. Contract manufacturing for the products in our GMP approved
facility. Technology transfer with equipment purchase & support
if needed. Non-exclusive / exclusive arrangement to deliver
treatments for your molecule. Customer defined pellets can be made
with customer ingredients / actives . Complete Technology transfer
from product to pilot to large scale production possible.
2. MICRO PELLETS BEADS IN BEAD TECHNOLOGY
www.umangpharmaceuticals.com Umang Pharmatech Pvt. Ltd. PRODUCT
DEVELOPMENT TECHNOLOGY Survey No. 146, H. No.1 (PT), Vasai Phata
Highway Junction, Pelhar, Nh8, Vasai (E) - 401 208, Maharashtra
(India). Tel. : (+91-22) 30018900 / 30018915 - 98, Mob. : (+91) 986
723 6594, Fax : (+91-22) 30018908 / 30018913 E-mail :
[email protected], Website : www.umangpharmatech.com /
www.umangpharmaceuticals.com STANDARD FEATURES : STANDARD FEATURES
: STANDARD FEATURES : Micro pellets technology for 100 / 200 / 300
/ 400 / 500 micron sizes. Dedicated project management with method
development and validation. Internal Technology transfer from
laboratory to pilot plant to commercial technology. Identifying the
right key process parameters. Full scale production of at least
three batches. Controlled drug delivery of the products is possible
with micro pellets. Can be compressed into tablets. Delayed or
Enteric release formulation development is possible. API release at
a specific point in body based on PH or other char. depending on
drug profile. Micro pellets have a higher bulk density compared to
API or granules. Fill weight of the product is higher in the
capsules due to smaller size. Dedicated equipments for development.
Short term accelerated physical stability studies before a full
scale development program. Dossier preparation per product with
scale up parameters for pilot and production scale. Contract
manufacturing for the products in our GMP approved facility.
Non-exclusive / exclusive arrangement to deliver treatments for
your molecule. Complete Technology transfer from product to pilot
to large scale production possible. Pulsed drug delivery is a
mixture of different release pattern are mixed. Dedicated project
management with method development and validation. Internal
Technology transfer from laboratory to pilot plant to commercial
technology. Identifying the right key process parameters. Full
scale production of at least three batches. Controlled drug
delivery of the products is possible with micro pellets. Dedicated
equipments for development. Short term accelerated physical
stability studies before a full scale development program. Dossier
preparation per product with scale up parameters for pilot and
production scale. Contract manufacturing for the products in our
GMP approved facility. Non-exclusive / exclusive arrangement to
deliver treatments for your molecule. Complete Technology transfer
from product to pilot to large scale production possible. Tailored
to meet your product requirements. A range of proto type
formulations are prepared under different process conditions.
Analytical techniques applied as appropriate to determine
formulation & process parameters. PULSED DRUG DELIVERY STANDARD
FEATURES : MUPS TECHNOLOGY Micro pellets technology for 100 / 200 /
300 / 400 / 500 micron sizes. The pellets are being put into
another large pellet size by a special process. This technology
avoids interaction between molecules. Dedicated project management
with method development and validation. Internal Technology
transfer from laboratory to pilot plant to commercial technology.
Identifying the right key process parameters. Full scale production
of at least three batches. Controlled drug delivery of the products
is possible with micro pellets. Can be compressed into tablets.
Delayed or Enteric release formulation development is possible. API
release at a specific point in body based on PH or other char.
depending on drug profile. Micro pellets have a higher bulk density
compared to API or granules. Short term accelerated physical
stability studies before a full scale development program. Dossier
preparation per product with scale up parameters for pilot and
production scale. Contract manufacturing for the products in our
GMP approved facility. Non-exclusive / exclusive arrangement to
deliver treatments for your molecule. Complete Technology transfer
from product to pilot to large scale production possible. Micro
pellets technology for 100 / 200 / 300 / 400 / 500 micron sizes.
The pellets are being put into another large tablet. This
technology avoids interaction between molecules. Dedicated project
management with method development and validation. Internal
Technology transfer from laboratory to pilot plant to commercial
technology. Identifying the right key process parameters. Full
scale production of at least three batches. Controlled drug
delivery of the products is possible with micro pellets. Can be
compressed into tablets. Delayed or Enteric release formulation
development is possible. API release at a specific point in body
based on PH or other char. depending on drug profile. Micro pellets
have a higher bulk density compared to API or granules. Short term
accelerated physical stability studies before a full scale
development program. Dossier preparation per product with scale up
parameters for pilot and production scale. Contract manufacturing
for the products in our GMP approved facility. Non-exclusive /
exclusive arrangement to deliver treatments for your molecule.
Complete Technology transfer from product to pilot to large scale
production possible.