pharmaceutical product development technology

2
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.

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Page 1: Pharmaceutical Product development technology

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.

Page 2: Pharmaceutical Product development technology

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.