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Dissolution testing is a requirement for solid oral dosage forms throughout the development life-cycle and commercial manufacturing. Our services for dissolution testing help understand the process in which a substance forms a solution and measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc.

Understanding the bioavailability and therapeutic effectiveness

The dissolution studies help to identify the significant changes (change of dosage form, qualitative formulation changes) likely to require bioequivalence studies and demonstrate the similarity between batches. Also, to determine the changes in the manufacturing process/excipient change (minor).

Our scientific team have experienced to analyze and report the results as per current regulatory requirements.

Aurigene provides the following GMP services

  • Development and validation of dissolution procedures
  • Dissolution/Drug release tests of different dosage forms
  • Two -stage dissolution with bio relevant media Small scale dissolution study at preclinical stage

A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes four standardized devices: basket, paddle, reciprocating cylinder, and flow-through cell. devices: basket, paddle, reciprocating cylinder, and flow-through cell.

  • Basket: Used to determine the drug release from solid oral dosage forms.
  • Paddle: Used to determine the drug release from solid / /liquid oral dosage forms.
  • Diffusion cell: Used to determine the drug release from semi solids, derma products, etc.

The release of the drug can be analyzed by UV or HPLC instruments.

Aurigene Pharmaceutical Services is

one of the leading contract research organization (CRO)

provides the best contract research manufacturing

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