Services - Oral Thin Film - CD Formulation

One-stop Integrated Solutions for Oral Thin Film Formulation

CD Formulation is an expert in oral thin film, working with our scientists on projects covering the entire formulation development and manufacturing, including pre-formulation studies, formulation design, material selection, process optimization, packaging and manufacturing, and regulatory compliance. Our integrated approach allows for a seamless transition from early development stages to commercial production, ensuring quality and efficiency throughout the entire process.

API Screening and Characterization

We can provide early-stage API find, screening, purchasing, testing, and characterization services for your oral film formulation development, accelerating the development and launch of your final product.

Inactive Ingredient Evaluation

We offer a wide range of inactive ingredient screening and evaluation services for your oral film dosage form development, including film-forming materials, plasticizers, flavorings and sweeteners, saliva stimulants, surfactants, super disintegrants, colorants, etc.

Characterization of Appearance and Physicochemical Properties

Relying on first-class equipment and fast and efficient internal general methods, we fully support the appearance and physical and chemical properties testing of oral film preparations, including but not limited to sensory evaluation, surface pH value...

Evaluation of Biological Properties

We perform complete biological characterization of oral film formulations as required by ICH Q6B guidelines, from in vitro disintegration and dissolution testing to in vivo release kinetics testing.

Stability Testing

Our state-of-the-art cGMP-compliant facility can assist you in conducting a wide range of your stability testing storage testing. Our stability testing services include long-term stability testing, intermediate stability testing, accelerated stability testing...

Process Development and Transfer

We support one-stop services from oral thin film process design to transfer, including process development, process optimization, process characterization and process verification, process transfer, etc., to ensure that your products obtain stable quality and efficient production efficiency during the production process.

Tests Performed to Support Your Oral Thin Film Formulation Development

Thanks to our deep expertise in oral film formulations, CD Formulation continuously explores, optimizes, and improves our in-house testing methods and equipment to meet the needs of the development of the pharmaceutical industry. With experience from hundreds of successful projects, our oral film experts can provide you with customized solutions and develop your unique oral film formulations with precision and efficiency.

Oral Thin Film Characterization

Mechanical properties characterization, e.g. folding endurance, tear resistance, tensile strength, thickness, breaking elongation, and Young‘s modulus.
Absorption performance testing.
Swelling properties testing.
Dispersion testing.
Content and content uniformity testing.
Moisture loss ratio testing.
In vitro disintegration testing.
In vitro dissolution testing.
Tack testing.
Release kinetics testing.
...

Quality Control Testing

Analytical method development and optimization.
Analytical method validation and transfer.
Release Testing, raw materials, intermediates, and finished products.
Process testing.
Controlled substance storage testing.
Long-term stability testing.
Accelerate stability testing.
In-use stability testing.
Forced degradation studies.
...

Instrumentation

High-performance liquid chromatography (HPLC).
UV/Vis Spectrophotometer.
X-ray diffraction (XRD).
Differential scanning calorimetry (DSC).
Thermogravimetric analysis (TGA).
Fourier transform infrared spectroscopy (FTIR).
Dissolution bath.
Disintegration bath.
pH meters.
Viscometers.
...

Why Choose CD Formulation?

Professional knowledge and advanced technology in oral thin film formulation development, process development, method development and validation, and packaging manufacturing.
Integrated testing services that can be coordinated support your drug development timeline.
Extensive experience in oral film the development of formulations and delivery systems and a track record of hundreds of successful projects.
Closely connect with external partners and regulators to accelerate the release and launch of your products.
End-to-end workflow from preformulation studies to commercial cGMP manufacturing.
Flexible analytical methods and process transfer capabilities allow for continuing to be developed in-house or transferred to your designated laboratory.
Fast and efficient internal general method, no need to start from scratch, saving time and cost.