DEFORMULATION/REVERSE ENGINEERING FOR PHARMA AND CONSUMER PRODUCTS
Do you want to save time and money while developing a version of a generic product? Whether you have intellectual property issues, analytical issues, safety issues, generic formulation design and development or you are looking to innovate your products as part of a new research and development (R&D) cycle we provide you deformulation/reverse engineering services for pharma and consumer products.
De-formulate to formulate
Reverse engineering or de-formulation is the analysis of a product where our lab breaks down a material or product to determine the identity, quantity and morphology of its components. The reports ensure the customers with sufficient information to allow them to recreate the product or make further changes to prepare a product that meets their needs. This is a crucial process to create generic versions of drug and consumer products.
Advantages of Reverse Engineering or de-formulation
- Reduced risk of product failure in stability and bio studies
- Minimize negative impact on environment
- Get to know how competitors’ products work
- Improvement in design of defective products
- Enhance parts design, optimize manufacturing techniques and select the right material.
- After the de-formulation of a product, the data can be used by an expert to explore how the ingredients are combined to make the pharmaceutical product.
Need for Reverse Engineer Medications
The generic companies usually require to demonstrate a bioequivalent product and discover a manufacturing method for a new medication in order to get approval for ANDA (Abbreviated New Drug Application) . The pharmaceutical is essential to prove bioequivalence and discover manufacturing methods for new medication.
The methods used to de-formulate a product are varied and depend upon the type of product and its complexity; usually methods applied from simple titrimetric to sophisticated instruments methods to identify & quantify the ingredients of products.
Why is this service important?
Deformulation/Reverse-engineering is applied for product development process and benchmarking, including competitor product analysis/to develop generic versions of products or to identify functional replacements for banned or obsolete ingredients.
For analytical purposes the minimum sample quantity required will be as per the study design, in case of clinical study the sample quantity may vary. Primarily, the sample quantity depends on the parameter. However, for competitors, the sample quantity increases.
We provide quick and diligent services with minimal turnaround time and sometimes, it also depends on the product’s complexity.
Purpose of testing
There are many industry purposes
- Get to know how competitors’ products work,
- Cost saving while developing a version of generic products,
- Identifying hazardous/impurity substances/design flaws in products
- Enhance parts design, optimize manufacturing techniques and select the right materials.
Experiments design varied based on product type and desired parameters of the customer. Broadly experimental design is based on the following category of analysis.
- Physical analysis
- Chemical Analysis
- Surface analysis
- Product performance analysis
There is no particular regulatory guidance for these kinds of studies. These studies are usually based on customer requirements. However, in pharmaceuticals generic drug development, de-formulation studies are carried out by Qbd approach as per ICH guidelines.
How are results used?
Industry used these results in improvising in the design of defective products, to recreate generic versions of RLD listed drug products. To enhance product performance by optimizing manufacturing techniques and selecting the right materials. Product patent infringements studies, etc.
Major equipment used
Auriga has a comprehensive array of Instrumentation facility for the de-formulation studies
- High Performance Liquid chromatography (HPLC)
- Liquid Chromatography and Mass Spectroscopy (LC-MS)
- Gas Chromatography (GC)
- Gas Chromatography- Mass Spectroscopy (GC-MS)
- Atomic Absorption Spectroscopy (AAS)
- Induced coupled Plasma (ICP-MS/OES)
- Fourier Transform Infrared spectroscopy (FT-IR)
- Thermogravimetric Analyser (TGA)
- Particle Size Analyzer
- X-Ray Diffraction (XRD)
Industries we serve
De formulation is widely used to support the development of new products in the Pharmaceuticals, Cosmetics and OTC Products, Household Products, Foods and Beverages industries.
There are limitations/challenges in de-formulation studies since there are no defined methods for the studies; however our expert team overcomes these challenges using their experience in analytical chemistry.
Our testing research centre is approved by ISO.
A glance at Deformulation / Reverse engineering at Auriga Research
Reverse engineering analysis is a complex and demanding task that requires a high level of proficiency. Scientists at Auriga have practical experience in analytical chemistry. We are equipped with state of the art equipment to provide accurate analysis of a wide array of retail products allowing your business to benefit from reverse engineering. We have an expertise in product active ingredient/component analysis in vitro product performance testing and physical characterization.
We identify hazardous /impure substances/design flaws in products. Besides, we also provide testing and analysis of competitor products.
Contact us for Reverse Engineering/De-formulation for pharma and consumer products.