Deformulation, also known as reverse engineering, is the separation, identification, and quantitation of ingredients in a pharmaceutical formulation. Successful launch of an oral thin film generic drug requires the developer to demonstrate comparability to the reference-listed drug (RLD) in terms of dosage form, route of administration, quality and performance characteristics, and intended use. Achieving this goal can be complex, especially when oral thin film drug products contain active pharmaceutical ingredients (APIs) with poor solubility or narrow therapeutic windows. As a leader in the field of oral thin film, CD Formulation not only has strong strength in developing oral thin film products but also has rich experience in the formulation analysis of oral thin film, which can provide customers with deformulation services for oral thin film drug development.

Our Oral Thin Film Pharmaceutical Deformulation Services

Our oral thin film pharmaceutical deformulation services involve the analysis and reverse engineering of commercially available thin film products. We use advanced analytical techniques to reverse-analyze the component, preparation process, physicochemical properties, biological properties, etc., of thin film samples, including drug release profile and stability under various conditions.

Fig.1 Our Oral Thin Film Pharmaceutical Deformulation Services. (CD Formulation)

Component Analysis

We perform a full composition analysis of the thin film sample to identify and quantify its active pharmaceutical ingredients, excipients, and other key components.

Preparation Process Analysis

We evaluate possible preparation methods through literature research and analysis results.

Physicochemical Properties Analysis

We conduct in-depth characterization of the physicochemical properties of the oral thin film, including its appearance, pH, flexibility, thickness, folding endurance, tear resistance, tensile strength, swelling properties, etc.

Drug Release Profile Analysis

We performed in vitro disintegration, in vitro dissolution, and release kinetics on thin film samples to understand how the active ingredients are released over time.

In addition, we can also reconstruct the original sample according to the analytical results of the thin film sample and compare the reconstructed sample with the original sample.

The Workflow of Oral Thin Film Pharmaceutical Deformulation

CD Formulation has a professional oral thin film formula analysis team and standardized analysis procedures, which can quickly respond to customers' testing needs. Our oral thin film pharmaceutical deformulation services process is as follows:

Fig.2 The Workflow of Oral Thin Film Pharmaceutical Deformulation Services. (CD Formulation)

Our Oral Thin Film Pharmaceutical Deformulation Services Capabilities

To best assist clients in reverse engineering their oral thin film pharmaceutical products, we are equipped with the most sophisticated analytical instruments, and we can help you with the reverse engineering of oral thin film products while providing tailored support.

• Gas Chromatography paired with Mass Spectrometry (GC-MS)
• Liquid Chromatography paired with Mass Spectrometry (LC-MS)
• Thermogravimetric Analyzer (TGA)
• ICP-MS and ICP-AES spectrometry
• X-ray Diffraction (XRD)
• Ion Chromatography (IC)
• Scanning Electron Microscopy paired with an EDX microprobe (SEM FEG EDX)
• Nuclear Magnetic Resonance (NMR)
• Infrared Microscopy (FTIR)
• ...

Advantages of Our Oral Thin Film Pharmaceutical Deformulation Services

• Full Report: Our clients receive a full report with supporting data and analysis details. Each deformulation project has a designated project manager, who provides regular updates and meetings.
• Professional: Our scientists have the skills and tools to successfully reverse engineer the most oral thin film pharmaceutical products.
• Rich Experience: Oral thin film reverse engineering analysis is a complex and demanding task that requires a high level of proficiency. Our scientists have practical experience in analytical chemistry.
• Advanced Analytical Equipment: We are equipped with state-of-the-art equipment to help customers provide accurate analysis of a wide array of oral thin film pharmaceutical products, allowing your business to benefit from reverse engineering.

CD Formulation has extensive experience in oral thin film pharmaceutical deformulation science. We can provide the latest technology and innovation to solve various complex problems. If you require our oral thin film pharmaceutical deformulation services, please contact us by phone or email, and our colleagues will get back to you within three working days.