Efficacy Evaluation of Oral Thin Film

Oral thin films are a new type of oral preparation, which has been attracting attention in recent years because of its lightweight, simple process and good compliance. Oral thin films do have some definite advantages for some special populations, such as no need to swallow, high drug compliance, easy adjustment of film dosage, buccal membrane absorption effect, etc. Based on the multiple advantages of oral films, the development of oral thin films as a novel drug delivery system is being pursued by several pharmaceutical companies. Therefore, evaluation of oral thin film efficacy has also become an important part of the development of oral thin film drug delivery systems.

CD Formulation has many years of research and service experience in the development of novel drug delivery systems. We provide oral thin film efficacy evaluations that can effectively determine the therapeutic efficacy and safety of a drug for a specific disease, and by evaluating the efficacy of a drug, we can determine the effectiveness of a specific disease. We can evaluate the safety of a drug, including the assessment of possible adverse reactions in patients. The efficacy evaluations of oral films that we provide play an important role in advancing research on oral thin film drug delivery systems and helping researchers obtain the desired films faster and better.

Our Process for Efficacy Evaluation of Oral Thin Film

Preclinical Studies

We carry out extensive preclinical investigations to ascertain the safety and effectiveness of our oral thin films. To provide solid data for the next development phase, we concentrate on assessing critical characteristics such as drug release kinetics, absorption, metabolism, and possible toxicity during the preclinical stage.

Pharmacokinetic and Pharmacodynamic Evaluation

At this stage, we meticulously evaluate the absorption, distribution, metabolism and excretion of oral film drugs by employing advanced analytical techniques, including mass spectrometry and biomarker analysis. In addition, we analyze the pharmacodynamic response to assess the expected therapeutic effect and provide guidance for further formulation optimization and clinical decision-making.

Stability Testing

We aim to evaluate the physical, chemical, and microbiological stability of the oral films under different environmental conditions to ensure shelf life and continued effectiveness.

Applications for Efficacy Evaluation of Oral Thin Film

• Efficacy evaluation of oral thin films ensures optimal drug release, bioavailability, and pharmacokinetic profiles to improve patient experience and therapeutic outcomes.
• Oral thin films offer a convenient and easy-to-use method of drug delivery, making them particularly suitable for pediatric and geriatric populations. With our service of efficacy evaluation of oral thin film, we can assist in the formulation of age-appropriate oral thin films to ensure accurate dosing, ease of use, and improved patient compliance.

Figure 1. FTIR spectra of rizatriptan, Proloc, HPMC F4M and drug-loaded buccal film. (Nair AB, et al., 2021)

Highlights of Our Oral Thin Film Efficacy Evaluation Services

• Specialized research team. Our research team has extensive knowledge and experience in designing custom oral films aimed at developing oral films that optimize drug release, stability and efficacy.
• Comprehensive efficacy evaluations. We conduct rigorous preclinical and clinical studies to evaluate the safety and efficacy of oral film formulations. Our comprehensive evaluations include pharmacokinetics, pharmacodynamics, bioavailability and overall therapeutic effect.
• Rigorous regulatory system. We conduct rigorous quality control as well as a regulatory environment throughout drug development and efficacy evaluation.

CD Formulation is an industry leader in oral film development and efficacy evaluation, providing accurate and efficient services in drug efficacy assessment studies. If you are interested in us, please feel free to contact us.

Reference

1. Nair AB, et al. Development of Mucoadhesive Buccal Film for Rizatriptan: In Vitro and In Vivo Evaluation. Pharmaceutics. 2021,13(5):728.