Pharmaceuticals

For pharmaceutical deformulation, it often involves the identification, quantification, and characterization of active pharmaceutical ingredients and all the excipients, both in the core and coating of a drug formulation^[1]. Deformulation makes use of physicochemical analysis tools to characterize, from the chemical point of view, the components integrating medicine pharmaceutical formulations and from the physical point of view, the morphological part of the pharmaceutical formulation. The project is of undeniable importance, since it is useful for developing generic drugs that meet bioequivalence requirements, identifying presumed counterfeit drugs, and other aspects related to drug development. While pharmaceutical deformulation may not seem very complicated, performing it in a lab can be very time consuming and complex. For many companies in the pharmaceutical industry, finding a specialist company that can perform this service effectively is critical. Alfa Chemistry has extensive experience in pharmaceutical deformulation and has completed the deformulation services for hundreds of drugs with different forms. We look forward to being your strategic partner.

Meet Our Services

The typical deformulation projects we undertake include, but are not limited to:

Development of generic drug products.
Identification of batch-to-batch variations.
Patent infringement or trade secret investigations.
Assessing and verifying the compliance of substances used in a pharmaceutical product compared to an SDS.

Characterization and investigation competitive product.
Comparative analysis of "good" and "bad" samples.
Improvement of an underperforming formulation.

We can offer pharmaceutical deformulation service for many prescription drugs, over the counter (OTC) drugs. They can be different formulation types, for example:

Gels
Lotions
Suspension
Inhalers
Emulsifiable granules
Oil-miscible liquids

Creams
Tablet
Controlled release products
Suppositories
Emulsifiable powders
...

Powders
Ointments
Capsule
Solutions
Granules

Even for the most complex drug formats such as injectable liposome drugs, injectable PLGA microsphere drugs and injectable nanoparticle drugs can be deformulated by Alfa Chemistry.

We offer two different types of pharmaceutical deformulation services to help you complete your project research:

Partial Deformulation

Some products are so complex that completely deformulate may not be cost-effective. For complex products, we can provide services to identify and quantify the major ingredients of the drug to gather critical information. This procedure we call a partial deformulation. The service is typically used to verify label claims and/or determine the ingredients specified by the customer.

Completely Deformulation

The service can identify and quantify all ingredients in pharmaceutical formulation. It mainly includes three main contents: (1) the identification of excipients, especially the identification of key excipients including solvents and dissolution regulators of BCS Class II or BCS Class IV drugs, wetting agents of hydrophobic drugs, pH regulators/buffers of pH sensitive drugs, and stability/antioxidant agents in readily oxidized and degraded drug formulation; (2) Separation/extraction of excipients and quantitative detection of excipients; (3) Solid state characterization of API, which may include rheology, particle size distribution, polycrystalline type, and crystallinity.

Our deformulation services are more than just identifying and quantifying ingredients, please contact us today to learn more about our services.

Techniques and Instruments

Alfa Chemistry uses various techniques and instruments for pharmaceutical deformulation, including but not limited to:

High Performance Liquid chromatography (HPLC)
Gas Chromatography (GC)
Gas Chromatography-Mass Spectrometry (GC-MS)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Atomic Absorption Spectroscopy (AAS)
Induced coupled Plasma (ICP-MS/OES)
Fourier Transform Infrared spectroscopy (FTIR)

Thermogravimetric Analyser (TGA)
X-Ray Diffraction Spectroscopy (XRD)
Scanning Electron Microscope (SEM)
ICP-MS and ICP-AES spectrometry
Ion Chromatography (IC)
Particle Size Analyzer
Microscopy
Karl Fisher
Nuclear Magnetic Resonance (NMR)

How We Proceed?

The workflow of deformulation service.

Please kindly note that our products and services are for research use only.