Any substance that can make a substance show the color required by the design is called a colorant, which can be organic or inorganic, natural or synthetic. Medicinal colorants should be edible, harmless to the human body, stable in physical and chemical properties, and not react with other ingredients in the drug. According to the application characteristics of oral thin films, colorants are often added in the process of preparing oral thin films, and their dosage is less than 1%. CD Formulation will select different colorants according to different populations and different age groups of patients, and screen suitable colorants to improve patient compliance.
Since the number of colorants used in the oral thin film is very small, it generally does not affect the physical and chemical properties of the oral thin film. However, the safety of the colorants is a concern that every pharmaceutical company must pay attention to. Our colorant screening services for oral thin film mainly includes but are not limited to the following:
Including the assessment of allergic reactions, toxicity, and carcinogenicity that may be caused by colorants. The toxicity and safety of colorants are usually determined through animal testing as well as human clinical trials.
Mainly related to the stability of the colorants in the ecosystem, bioaccumulation, water quality, and soil pollution. Environmental monitoring and simulation experiments are used to evaluate the potential hazards of colorants in the environment.
According to international safety standards and regulations, the use limit of colorants is also an important part of assessing safety. Different types of oral thin film have different limits for the use of colorants and generally require that the daily intake of the human body does not exceed a certain limit.
Safety evaluation is not a one-time process, the use of colorant safety needs to be long-term monitoring and evaluation.
Technologies & Platform | Description |
Analysis Platform | We carry out comprehensive physical and chemical testing of colorants, including pH, heavy metals, microorganisms, etc. |
Screening Platform | We are familiar with the nature of various colorants, according to the preparation process of the oral soluble film, choose the right colorant, but also according to the flavor agent used in the oral soluble film, match the best colorant. |
Safety Evaluation Platform | The safety assessment of colorants is mainly concerned with effects on human health and potential hazards to the environment. Our human health risk assessment and environmental risk assessment mainly involve the assessment of allergic reactions, toxicity assessment, carcinogenicity assessment, pollution to the ecosystem assessment, etc. |
Technology: Colorant
Journal: Pharmacy and Pharmaceutical Sciences Commons
IF: 3.7
Published: 2022
Results: Colorants may be incorporated to enhance the aesthetic characteristics of oral thin films and to provide an opportunity to differentiate and market one's products. Coloring agents should be incorporated below concentration levels of 1% w/w.
CD Formulation can bring the most professional colorant screening technical guidance for customers. If you have a requirement about our colorants screening for oral thin film services, please contact us by phone or email, and our colleagues will reply to you within three working days.
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