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Applications for Efficacy Evaluation of Oral Thin Film

Inquiry

Oral thin films offer a convenient and easy-to-use method of drug delivery, making them particularly suitable for pediatric and geriatric populations. 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.

Fig.1 Development and evaluation of buccal films.Fig.1 Development and evaluation of buccal films for treatment of oral candidiasis. (Derya Arslan, et al., 2023)

Importance of Oral Thin Film Efficacy Evaluation

Oral thin film is an increasingly popular pharmaceutical dosage form, known for its convenience, ease of administration, and rapid onset of action. The efficacy evaluation of oral thin film formulations is essential for ensuring patient safety, treatment efficacy, medication adherence, regulatory approval, and informed clinical decision-making, it provides support and basis for safe drug use in patients.

  • Oral thin film efficacy evaluation is to determine the bioavailability and pharmacokinetics of the active drug ingredient.
  • Oral thin film efficacy evaluation helps determine whether oral thin film is effective in treating the targeted condition or disease.
  • Oral thin film efficacy evaluation helps assess any potential adverse effects, drug interactions, and toxicity.

Our Oral Thin Film Efficacy Evaluation Services

Oral thin film efficacy evaluation projects typically involve preclinical investigations, pharmacokinetic and pharmacodynamic evaluation and stability studies to determine the safety and effectiveness of the thin films.

  • Preclinical Investigations: Our preclinical investigations process includes physical stability, water resistance, film thickness, folding endurance, surface pH, flavor, average weight, disintegration time, etc.
  • Pharmacokinetic Evaluation: Our pharmacokinetic evaluation includes the absorption, distribution, metabolism, and excretion of thin film in the body.
  • In Vitro and In Vivo Studies: Testing the performance of oral thin film in laboratory settings and in animal models can provide data on its dissolution rate, bioavailability, and efficacy in delivering the drug.
  • Stability Studies: 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.

Our Capabilities for Evaluating Oral Thin Film Efficacy

  • FT-IR study
  • Mechanical properties evaluation
  • Drug content and uniformity analysis
  • In vitro disintegration time
  • In vitro dissolution study
  • Kinetic modeling of oral thin film
  • Pharmacokinetic and pharmacodynamic evaluation
  • Stability testing

Our Advantages in Evaluating Oral Thin Film Efficacy

  • We have created an advanced oral thin film formulation development technology platform that allows us to develop high-quality oral thin film drugs.
  • We conduct rigorous quality control as well as a regulatory environment throughout drug development and efficacy evaluation.
  • We understand that each oral thin film formulation is unique, and we can provide tailored evaluation services to meet the specific needs and requirements of our clients.
  • We work closely with our clients and provide ongoing support and communication throughout the evaluation process.

Published Data

Technology: In Vitro/In Vivo Evaluation

Journal: AAPS PharmSciTech

IF: 3.3

Published: 2017

Results: In this study, designed mucoadhesive buccal film containing fluticasone and selected formulations with adequate properties were further examined by differential scanning calorimetry (DSC) and X-ray diffraction (XRD) and subjected to in vivo evaluation. Films containing hydroxypropyl methylcellulose (HPMC)/ethyl cellulose (EC) showed acceptable physicochemical properties, homogenous drug distribution, convenient mucoadhesion time, moderate swelling as well as sustained drug release up to 12 h. The biological performance of these formulations was assessed on healthy human volunteers and compared with a prepared mouthwash which showed enhanced pharmacokinetic parameters for the selected films in comparison to the mouthwash.

Fig.2 Release profiles of fluticasone propionate from mucoadhesive film.Fig.2 Release profiles of fluticasone propionate from mucoadhesive film. (Hussein O. Ammar, et al., 2023)

CD Formulation insists on innovation and continuous improvement, and always remains at the forefront of the oral thin film industry. We provide reliable oral thin film efficacy evaluation services to help our customers enhance the development of oral thin film products. If you have a requirement about our oral thin film efficacy evaluation services, please contact us by phone or email, and our colleagues will reply to you within three working days.

References

  1. Derya Arslan, Özlem Akbal Dağıstan, et al. Development and Evaluation of Combined Effect Buccal Films for Treatment of Oral Candidiasis. AAPS PharmSciTech. 2023, Vol(24).
  2. Hussein O. Ammar, Mahmoud M. Ghorab, et al. Design and In Vitro/In Vivo Evaluation of Ultra-Thin Mucoadhesive Buccal Film Containing Fluticasone Propionate. AAPS PharmSciTech. 2017, Vol(18): 93-107.
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CD Formulation, an expert in novel oral thin film delivery systems, is dedicated to supporting pharmaceutical companies in developing and commercializing innovative drug formulations...

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