Dissolution Testing Services

Avivia Pharmaceutical Development Services, dissolution support

 

The experience and knowledge-based pharmaceutical dissolution development platform within Avivia focuses primarily on supporting formulation development and problem solving.

For us, dissolution testing is never a routine test, but an essential tool in pharmaceutical formulation development to:

      • evaluate the physico-chemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation)
      • perform biorelevant in-vitro tests to mimic fed and fasted state conditions
      • compare prototype formulations (preclinical selection)
      • elucidate drug release mechanism (diffusion, erosion, etc.)
      • as an indicator of stability (e.g., temperature, humidity)
      • as an indicator of the robustness of the manufacturing and
      • assure safe release and reproducibility of the products to the market.

 

Dissolution testing should be a discriminatory method that is sensitive to variables affecting release rate and ideally has a predictive value for bio-performance.

It takes a lot of skills, knowledge and experience to design dissolution testing methods that contribute to the development of safe, robust and successful pharmaceutical dosage forms.

Avivia Dissolution Services: dissolution apparatus IV flow through cell

Dissolution Apparatus Equipment

Within Avivia dissolution testing development services laboratory we have a complementary range of dissolution testing equipment available:

USP 1 / apparatus I / apparatus 1 / Basket dissolution apparatus
USP 2 / apparatus II / apparatus 2 / Paddle dissolution apparatus
USP 3 / apparatus III / apparatus 3 / Reciprocating cylinder dissolution apparatus / BioDis
USP 4 / apparatus IV / apparatus 4 / Flow through cell dissolution apparatus

Pion µDiss Profiler (low volume in situ fiber optic UV monitoring dissolution and solubility system)

Intrinsic dissolution testing and other dissolution techniques

As intrinsic dissolution apparatus both the Pion µDiss Profiler and Wood apparatus are present. Specific flow cells for our flow through cell dissolution apparatus are used for apparent dissolution testing of powders, like granules and active pharmaceutical ingredients.

And if required, other less common or more academic dissolution testing techniques are accessible in our network, or we design a custom made dissolution setup.

But most important we know how and when to apply all these systems in support of formulation development, troubleshooting and optimization.

USP Apparatus III
Reciprocating Cylinder/BioDis in action
USP Apparatus IV
Flow Through Cell apparatus
USP Apparatus IV
Different types of flow cells:

(from left to right)

Flow cell for powders and granules

Flow cell for small tablets

Flow cell for large tablets
Pion µDiss Profiler
Low volume in situ fiber optic UV monitoring dissolution and solubility system
Previous
Next

Dissolution Case Study: drug vs hypromellose release

The specific analytical methodologies from the Avivia excipient expertise center Excipia allows us to determine not only drug release, but also other relevant drug product characteristics, such as, for example, hypromellose (HPMC) release from a controlled release hypromellose matrix tablets. 

Drug and hypromellose dissolution profile

In this particular case, drug and HPMC release was monitored with the USP apparatus III (BioDis). The HPMC release was found to be faster than that of the drug itself; the release mechanism was primarily controlled by erosion. The diffusion-controlled release mechanism was almost absent, making the pharmaceutical formulation extremely sensitive to the HPMC properties. These properties were investigated extensively experts of Excipia and subsequently controlled by defining in-house specifications. Read more.

 

In cooperation with our clinical research partners we have successfully established in-vitro in-vivo correlations (IVIVC) for several modified release dosage forms.

 

in-vitro in-vivo correlation (IVIVC)