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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.

Dosage Form
Challenge

Tablets (immediate and modified release)

Even for simple formulations such as tablets and capsules, dissolution can be very challenging when it comes to obtain a discriminative method, able to correlate with in vivo performance or addressing technical issues such as coning effect or poor API solubility.

Capsules, pellets

Some dosage forms are inducing a lot of analytical artefacts especially such as floating material or capsule interference. It is critical to use appropriate technical solutions to address these issues and ensure reproducibility of results.

API's, powders, granules

Although dissolution testing of powders dosage forms is described since years, its use for API characterization is growing together with the out-sourcing of raw material. It allows to compare the dissolution of both API and dosage form and to assess their relative importance.

Soft-gelatin capsules, suppositories

Due to their poor solubility, more and more API are formulated using lipophilic dosage forms. The presence of lipidic excipients may add complexity to the corresponding dissolution methods and require extra-attention when developing them.

Medical devices, stents, implants, coated lenses

Developing medical devices combined with drugs can be challenging due to the respective regulations. Having a good understanding of the behavior of both drug and device, expectations of the Authorities and available technical solutions allows to tackle such complicated testing with simple and robust methods.

Microspheres, nano-suspensions

Microspheres are part of a growing field related to the use of dispersed dosage forms for the administration of poorly soluble compounds or highly potent drugs. Being frequently used at low dose or with nano-particles as carrier, their in vitro testing may be very challenging with yet no standardized methods.

Injectable suspensions

Dissolution testing was thought only for oral dosage forms. Injection getting more and more importance for the administration of drugs,in vitro testing is now required to characterize in vitro the behavior of injectable products. Though it is very challenging to obtain discriminating methods using conventional solutions and without expertise.

Semi-solids, gels, creams

The characterization of topical forms such as creams and gels is gaining importance with the recent publications related to the TCS(Topical Classification System) with in vitro release testing becoming a key stone. However, the method to use may vary depending on the properties of the dosage forms and requires special attention for its development.

Transdermal patches

The methods to be used are well known but their development is not yet completely straight forward, especially because of the various types of patches and the relatively poor solubility of the API used.