R&D Services –
For your formulation.

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Thanks to our unique know-how, based on decades of experience in the development of methods for pharmaceutical products, we offer a wide range of R&D and QC services to help customers overcome the various challenges associated with the development of robust analytical methods in a fully GMP compliant environment. This expertise relates to both analytics and formulation and includes specialized knowledge of small and large molecules, immediate and modified release dosage forms, and oral and parenteral routes of administration.

API Screening & Characterization

API Screening
& Characterization

Analysis of how API characteristics impact on processability of the powder, dissolution of the drug, bioavailability, and stability.

 

An examination of the effects that the properties of the API have on the powder's processability, the drug's solubility, bioavailability, and stability.

Microdialysis-based IVRT

Microdialysis-based
IVRT

IVRT studies based on a novel in-vitro technique for complex formulations such as liposomes, injectables, or ophthalmic suspensions.

 

IVRT investigations for intricate formulations like liposomes, injectables, or ocular solutions that rely on a revolutionary in-vitro methodology.

Solubility Studies

Solubility
Studies

Evaluation of the solubility of your API in one or more aqueous media mimicking the physiological conditions and allowing to fulfil sink conditions.

 

An assessment of your API's solubility in one or more aqueous mediums that replicate physiological settings and meet sink requirements.

IVPT of Oral Dosage Forms

IVPT
of Oral Dosage Forms

In-vitro permeation testing to assess bioequivalence (BE). Predict IVIVC and rank order formulations to increase the success rate of your BE study.

 

Bioequivalency (BE) evaluation using in vitro permeation testing. To improve the likelihood that your BE study will be successful, predict IVIVC and rank order formulas.

Method Development

Method
Development

From quickly evaluating the technical feasibility of a method to optimization and executing all required steps for filing a complete finalized method.

 

From swiftly assessing a method's technical viability to optimising it and carrying out all necessary procedures to submit a fully developed method.

IVPT of Topical Dosage Forms

IVPT
of Topical Dosage Forms

In-vitro permeation testing to evaluate drug delivery into the various skin layers and to select formulations for topical and transdermal application.

 

To assess medication transport into the different layers of the skin and choose formulations for topical and transdermal use, in-vitro permeation testing is used.

In-Vitro Release Testing (IVRT)

In-Vitro
Release Testing (IVRT)

Dissolution testing with different apparatus types, methods, automation levels and test setups to determine the most robust method.

 

Dissolution testing to identify the best reliable approach using various apparatus kinds, techniques, automation levels, and test configurations.

Deformulation

Deformulation /
Reverse Engineering

Reverse engineering to determine the formulation composition of a reference drug for generic pharmaceutical companies.

 

Reverse engineering is used by generic medication manufacturers to ascertain the formulation composition of a reference drug.

Q3 Characterization

Q3
Characterization

Achieve Q1 / Q2 similarity and perform Q3 characterization to obtain a biowaiver for your complex generic product approval.

 

Attain Q1/Q2 similarity and carry out Q3 characterization to secure a biowaiver for the approval of your complex generic product.

Analytical Method
Automation

Analytical Method
Automation

Complete method transfers from manual to automated platforms with comparison studies and final transfer report.

 

Complete method transfers, including comparison studies and a final transfer report, from manual to automated systems.

IVIVC (In-Silico Simulation)

IVIVC
(In-Silico Simulation)

Develop IVIVC models, evaluate predictability, establish specifications for dissolution, and apply IVIVC as a surrogate for in-vivo bioequivalence studies.

 

Create IVIVC models, assess predictability, set dissolution requirements, and use IVIVC as a stand-in for in vivo bioequivalency testing.

Cleaning Validation

Cleaning
Validation

Analysis of cleaning swabs to develop a robust manual or automated method for regular cleaning validation by the customer.

 

Analysis of cleaning swabs to provide a reliable manual or automated process for the customer's regular cleaning validation.

Experts in Flow-Through Cell Dissolution.

SOTAX is built on flow-through cell dissolution and a true pioneer in this field since 1972. While the flow-through cell technology excels with excellent bioequivalence and allows researchers to see things that may otherwise remain unnoticed with conventional paddle & basket dissolution methods, it has remained an area of limited scientific expertise at many R&D laboratories. That's where Pharma Services can help to accellerate product development by assisting in the development of robust flow-through cell dissolution methods.

Advantages of flow-through cell dissolution:
 

  • Maintain sink conditions for poorly soluble compounds
  • Ideal whenever low-volume dissolution media is required
  • Compendial testing of novel dosage forms (e.g. LNP, liposomes, etc.)
  • Easily perform pH changes for IVIVC studies
  • Solves many challenges of conventional paddle methods such as floating or sticky products, and inherent sampling issues
  • Can be used for API characterization (apparent dissolution in Ph.Eur. 2.9.43)
  • Recommended method for injectable suspensions

Contact us now to learn more about flow-through cell dissolution and how to expedite your product development.

Need help with your Dissolution Method?

Method Development

Method Development

Entrust the development of your method to a true dissolution expert. Our Pharma Services are based on 50 years of experience with complex dosage forms. Typically starting with a feasiblity study, finding the right testing parameters for your product is one of our core competencies - and has resulted in the development of robust and reliable methods for customers all over the world.

Using the same tried-and-true quality management system, three labs—one in Europe, one in the USA, and one in India—offer best-in-class services in an FDA-inspected and GMP-certified setting.

Method Optimization

Method Optimization

You already developed a method on your own, but you’re not fully satisfied with its robustness or reproducibility? Our team of dissolution experts performs Design of Experiment (DOE) studies and empirically establishes how small changes of method parameters can positively impact on the reliability of drug release processes - making your dissolution results more conclusive and improving repeatability.

Comprehending the requirements of multiple disciplines is fundamental to our Pharma Services.

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