The launch of a successful generic drug is a meticulous process that hinges on proving comparability to the innovator Reference Listed Drug (RLD) in several key aspects: dosage form, route of administration, quality and performance characteristics, and intended use. This requires that generic drugs must exhibit equivalency in qualitative (Q1), quantitative (Q2), and critical material attributes (Q3) to RLD. Achieving this equivalency is inherently complex, especially as many drug products contain APIs with poor solubility or have a narrow therapeutic window, and it requires a deep understanding of the original drug's formulation. Therefore, the heart of successful generic drug development is the necessity for formulators to "decode" the critical material attribute of both the APIs and excipients in RLD. This process is known as reverse engineering or deformulation. Generally, reverse engineering involves extracting vital information about the drug's chemical, physical, and biological properties. Our company has established itself as a leader in the reverse engineering of pharmaceuticals, with years of experience in pharmaceutical research and development. Our team comprises skilled scientists, formulation experts, and regulatory specialists dedicated to providing reverse engineering services to accelerate the development of generic pharmaceutical products.
Our Services
We offer a comprehensive suite of analytical services focused on understanding the composition and functionality of excipients and APIs to meet the stringent demands of generic drug development. Details are shown below.
Excipients Composition and Dosage Analysis
Our services include detailed analysis of the type and amount of excipients used. This process involves:
- Detailed Profiling: Identifying each excipient and understanding its specific role within the formulation.
- Dosage Quantification: Accurately determining the quantity of each excipient.
Quality Research of Functional Excipients
Our services extend to the quality assessment of functional excipients. This includes:
- Quality Metrics: Assessing purity, potency, and functional performance of excipients.
- Impact on Drug Properties: Analyzing how functional excipients influence drug polymorphism, rheology, and other critical quality attributes.
Physical and Chemical Properties Evaluation Evaluating the physical and chemical properties of both the test product and inactive ingredients used in RLD products is a pivotal aspect of our service. This includes appearance and pH testing, particle size and rheological behavior, and drug release profiling.
Solid State Characterization of API
Our services include extensive characterization of APIs, focusing on rheology, particle size distribution, polycrystalline type and crystallinity.
We are equipped to provide reverse engineering service for a diverse array of drug formulations, including:
- Oral Solids: Tablets, capsules, powders and others.
- Oral Liquids: Solutions, suspensions, syrups and others.
- Topicals: Creams, ointments, gels and others.
- Parenterals: Injections, IV formulations and others.
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Each category entails specific challenges and requirements, and our team possesses the in-depth understanding needed to navigate these complexities.
Instruments and Equipment
Our state-of-the-art laboratory is equipped with cutting-edge instruments that facilitate precise analysis and determination. Key equipment includes:
- High-performance liquid chromatography (HPLC)
- Differential scanning calorimetry (DSC)
- Fourier-transform infrared spectroscopy (FTIR)
- Gas chromatography (GC)
- Gas chromatography-mass spectrometry (GC-MS)
- Liquid chromatography-mass spectrometry (LC-MS)
- Atomic absorption spectroscopy (AAS)
- 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)
These instruments, operated by our skilled technicians, provide the accuracy and reliability necessary for successful reverse engineering projects.
Our Advantages
- Expertise and Experience: We leverage our deep understanding of pharmaceutical science to deliver exceptional reverse engineering solutions, consistently achieving high levels of customer satisfaction.
- Compliance and Quality Assurance: We prioritize compliance with regulatory standards, ensuring that every stage of the reverse engineering process meets guidelines, and we perform rigorous quality assurance protocols to delivering accurate result.
- Collaborative Approach: We will form strong partnerships with our clients, maintaining open lines of communication throughout the project lifecycle.
- Cost-Effective Solutions: Our efficient methodologies and strategic planning allow us to offer competitive pricing without compromising quality.
Our reverse engineering services provide a robust framework for the successful development of generic drugs. Through comprehensive analysis, advanced equipment, and unwavering dedication to quality, we empower pharmaceutical companies to expand their product offerings and meet the ever-growing demand for affordable healthcare solutions. If there is any need, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
