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Content

For
Experts
By
Experts.

The unique application know-how and experience of SPS Pharma Services continues to help pharmaceutical companies worldwide in overcoming the various challenges associated with dissolution and release testing from pharmaceutical dosage forms. Being the only company specialized in dissolution testing, SPS Pharma Services has a proven track record of finding the most suitable method for products ranging from APIs and tablets to implants, semi-solids, and many more. Set in a cGMP-compliant environment with strict quality management processes, the scientific expertise of our staff paired with state-of-the-art instrumentation ensures best-in-class services and ease of regulatory compliance for our customers.

Understanding
inter-disciplinary
needs.

Currently, there is no standardized pharmaceutical development process. The development strategy depends greatly on whether it is a new chemical entity or generic, or if the product is developed by a startup versus Big Pharma.

Dissolution is a critical and essential test for drug development and production. It is not only used for solid oral products like tablets and capsules but also for many other dosage forms such as microspheres, suspensions for injection, and implants.

With dissolution being an analytical tool related to API properties, formulation composition, manufacturing process, and biopharmaceutical performance, it requires a strong understanding of these various fields in order to utilize its complete potential.

SPS Pharma Services brings unique knowledge and expertise to its clients and is able to take all your requirements into account. Our inter-disciplinary approach, emphasizing exchange of information between analysts, formulators, or clinicians, helps to empower the use of dissolution testing. With this powerful approach we overcome problems such as lack of know-how about special products, limited literature available, or no obvious or established testing method.

API

Formulation

Analytics

Instrumentation

Clinical

Regulations

Production

360°

Finding the
most suitable
method.

Dissolution has gained significance because of its importance as a Critical Quality Attribute (CQA), a major surrogate for pharmacokinetic performance and bioavailability. It is used throughout the product lifecycle, from discovery of the active molecules and their selection until marketing of the drug product and post-approval monitoring.

An understanding of the mechanisms of dissolution constitutes the basis for determining the potential factors affecting drug substance release when screening candidate formulations (selection of drug substances, excipients, manufacturing processes, and dosage forms).

However, the use of the dissolution test and its prerequisites can vary considerably throughout the product lifecycle.

Our know-how about both, pharmaceutical dosage forms and release testing equipment enable us to offer customized development strategies in order to fulfill your requirements and make sure the developed method is fit-for-purpose – be it in formulation screening, IVIVC, or Quality Control.

A) Challenge

Complex dosage form, failed bioequivalence study, manufacturing issue

B) Equipment

Dissolution
(USP 1, 2, 3, 4, 5, 6, 7)

Content testing
(uniformity, assay)

Automated platforms

C) Know-how

Formulation properties, methods, analytics, instrumentation capabilities

D) Solution

The most suitable method for your product

Our
Services.

API screening &
characterization

  • Comparison of API sources and supply chain assessment
  • Identification of possible first candidates
  • Intellectual property protection for new chemical entities

Feasibility studies

  • Selection of the most suitable method for your application by testing possible candidates & first formulations
  • Comparison of all compendial dissolution methods described in Pharmacopeias (US, EU, JP, etc.)

Method development

  • Optimization of the operating parameters to achieve a robust, validatable, and acceptable method
  • Understanding of the authorities’ expectations with regards to method justification
  • In-vitro pharmaceutical equivalency testing

Method validation & revalidation

  • Validation of new methods and revalidation of existing methods with clearly defined protocols as well as detailed validation reports
  • Post-marketing re-testing (SUPAC, lifecycle management, etc.)

Routine Analytical Services

SPS Pharma Services is an established organization able to fulfill the need of its clients for a one-stop solution from method development to routine GMP testing. This complete solution minimizes the risks inherent to method transfers.

Method automation

  • Assessment of method transfers to automated platforms for dissolution and sample preparation
  • Complete method transfer from manual to automated platforms with comparison studies and final transfer report

Method transfer

  • Complete analytical method transfer from R&D to QC or from site to site
  • Preparation of transfer protocols with clearly defined acceptance criteria, comparison studies, and final transfer report

Routine Analytical Services

SPS Pharma Services is an established organization able to fulfill the need of its clients for a one-stop solution from method development to routine GMP testing. This complete solution minimizes the risks inherent to method transfers.

Method validation & revalidation

  • Validation of new methods and revalidation of existing methods with clearly defined protocols as well as detailed validation reports
  • Post-marketing re-testing (SUPAC, lifecycle management, etc.)

API

API Screening

  • Intrinsic dissolution
  • Apparent dissolution
  • Processability

Formulation

API & Excipients

  • Dissolution
  • Analytics (UV, HPLC, UPLC)
  • Particle size
  • Binary mixture stability
  • Excipients comparison
  • Powder properties

Final Dosage Form

Final Dosage Form

  • Dissolution
  • Content testing
  • Physical testing
  • Feasibility PAT/NIR

GMP Batch Testing

  • All testing
  • Analytical method validation
  • Systematic stability testing

Manufacturing of
Commercial Batches

Routine Testing

  • Dissolution
  • Content testing
  • Physical testing

Post-approval Monitoring

  • Periodic stability testing
  • Scale-up & post-approval changes
  • Lifecycle management
  • Biowaivers

Your
Applications.

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