Introduction Formulation and Development

By: Pharma Tips | Views: 4395 | Date: 17-Aug-2013

A formulation is a mixture that is prepared according to a specific procedure (called a “formula”). Formulations are made for particular applications and normally are more effective than their individual components when these are used singly.Formulations are commercially produced for drugs, cosmetics, foods, paints, coatings, cleaning agents, and many other things.

Introduction Formulation and Development

Introduction Formulation and Development

A formulation is a mixture that is prepared according to a specific procedure (called a “formula”). Formulations are made for particular applications and normally are more effective than their individual components when these are used singly.
Formulations are commercially produced for drugs, cosmetics, foods, paints, coatings, cleaning agents, and many other things.

Innovative Development
• Preformulation studies
• Formulation development
• CTM manufacturing
• Stability studies
• Evaluation of new delivery technologies
• Formula and process optimization through DOE

•  Physico-chemical characterization of drug substance
•  Polymorphism studies
•  Powder X-ray diffraction
•  Qualitative and quantitative thermal analysis
•  Solubility and partitioning studies
•  Salt form selection
•  Excipient compatibility studies
•  Packaging compatibility and extractability studies
•  Forced degradation studies

•  Tablets, capsules, liquids, suspensions and semi-solids
•  Reformulations and line extensions
•  Modified and controlled release tablets and capsules
•  Controlled substance (Schedule I-III)
•  Evaluation of packaging presentations based on formulation requirements
•  Bottle, blister, sachet and tube packaging
•  Clinical supply and placebo manufacture Phase I-III
•  Review of batch documentation by Quality Assurance team

Analytical Research
•  Method development and validation for Phase I-III
•  Process development support and release testing
•  Cleaning validations for manufacturing equipment
•  Non-compendial method development and validation
•  Drug substance impurity profiling (HPLC)
•  Dissolution studies (ICH guidelines and customer design)
      -  Validated environmental chambers
      -  25C/60%RH, 30C/65%RH
      - 40C/75%RH, 25C/40%RH
      - 40C/25%RH, 5C, photostability
•  Microbiological methods validation and testing method development and testing
•  Stability
Previous Page Next Page

People Searching On This Page:
  • formulation R and D
  • application of preformulation considerations in development of dosage forms
  • nmt4
  • introduction of preformuLations articles
  • stability studys
  • guideline for row market formulation development

Related Pages

Preformulation: In Development of dosage form

Preformulation: In Development of dosage form

Articles | F & D
21-Aug-2013  Views: 6408

Almost all drugs are marketed as tablets, capsules or both. Prior to the development of these major dosage forms, it is essential that pertain fundam ...
Introduction Research & Development

Introduction Research & Development

Articles | R & D
17-Aug-2013  Views: 3682

Research and development (R & D) is a process intended to create new or improved technology that can provide a competitive advantage at the business, ...
R&D Officer/ Executive ( Pharma - Formulation Development )

R&D Officer/ Executive ( Pharma - Formulation Development )

Jobs | R & D | Mumbai
26-May-2013  Views: 4945

(UG - B.Pharma - Pharmacy) AND (PG - M.Pharma - Pharmacy) AND ( Doctorate - Doctorate Not Required)M. Pharma/ B. Pharma with 2 - 5 years experience in ...
Formulation Development  Preformulation

Formulation Development Preformulation

Articles | F & D
05-Apr-2013  Views: 5570

Pharmaceutical preformulation is a stage of drug development during which the physicochemical properties of Active Pharmaceutical Ingredients (APIs) a ...
Formulation & Development - Anda Row

Formulation & Development - Anda Row

Jobs | F & D
08-Nov-2012  Views: 5401

Posted By - Job Tree. Keywords - ANDA, regulated market, ROW. Job Description -   1.      To develop products for ANDA filings as per the timelines/ ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

65  + 9 =     
People Searched About:
Formulation R And D   |   Application Of Preformulation Considerations In Development Of Dosage Forms   |   Nmt4   |   Introduction Of Preformulations Articles   |   Stability Studys   |   Guideline For Row Market Formulation Development   |  
Google : 306 times | Yahoo : 15 times | Bing : 130 times |