How Tergus Leads the Industry with In Vitro Release Testing (IVRT)
Some of you may know that Tergus co-founder, Kailas Thakker, was involved in the development of in Vitro Release Testing (IVRT), recognized as an essential testing protocol for semi-solid dosage forms. Her work led to the development of the SUPAC-SS guidance document that the pharmaceutical industry follows. She is a member of the USP’s Advisory Panel and helped draft chapters 3 and 1724. She is also a member of USP’s Expert Committee on Dosage forms for the current revision cycle.
What you may not know is that the company does not stop there. Tergus has the largest bank of diffusion cells used for IVRT in the industry. The bank also features cells from a variety of manufacturers. This allows us to do tests that give better data and allows us to customize protocols to deal with challenging, hydrophobic APIs or formulations.
At the most recent AAPS annual meeting, scientists from Tergus presented a poster titles “Developing in vitro methods for petrolatum based semi-solid dosage forms.” The poster states that “due to the high viscosity of ointment formulations and low diffusion coefficients of drugs through these high viscosity ointments, they frequently create a substantial challenge during the development of adequate release rate methods.”
The experiments presented in the poster used standard vertical diffusion cells or immersion cells as described in USP and had receptor volumes ranging from 8-15 mL, with surface areas ranging from 1.0-1.767 cm. The experiments evaluated petroleum-based ointments with both hydrophilic and hydrophobic properties. The difficulties in obtaining optimal results with these formulations were overcome by implementing atypical IVRT method conditions and by selecting the cells most suited for the formulation.
The results demonstrated that success for these challenging formulations could be overcome by using stronger solvents and by using an immersion cell system. This methodology, developed by Tergus scientists, allows for “significantly higher release of the active ingredient than could be achieved with conventional vertical diffusion cells.”
Tergus stands out, not only for the deep expertise that we have in IVRT, but in the fact that we have worked to go beyond standard expectations, looking for novel solutions to difficult formulations and acquiring the right equipment. Additionally, we have developed an internal classification system, based on the Biopharmaceutics Classification System (BCS). The Tergus BCS system allows us to quickly classify how soluble or insoluble a formulation or API is and develop optimal strategies to obtain the best data. This internal system saves time and delivers the kind of results our clients need.
When you look for the kind of expertise needed to get optimal results the first time, look no further than Tergus.
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