Advanced rAPSD and Dissolution Testing Services
Advanced rAPSD and Dissolution Testing Services
Why Choose Our Testing Services?
At Emmace, we specialize in providing cutting-edge Realistic Aerodynamic Particle Size Distribution (rAPSD) and Dissolution Testing services, crucial for the development of generic inhaled drug products (OIDPs) and claiming bioequivalence. Our comprehensive testing solutions are designed to meet the highest standards of accuracy and reliability.
Realistic Aerodynamic Particle Size Distribution (rAPSD)
Key Benefits:
- Accurate Lung Deposition Insights: Our rAPSD testing uses anatomical mouth-throat models and realistic breathing profiles to closely mimic in vivo conditions. This provides precise data on how drug particles are distributed within the lungs, crucial for ensuring effective drug delivery and therapeutic outcomes.
- Patient-realistic Approach: By incorporating patient-specific variability, our rAPSD testing offers a more accurate representation of how different patient anatomies and inhalation efforts impact drug deposition. This helps in optimizing formulations and devices.
- Regulatory Compliance: Our rAPSD testing methods align with the latest FDA guidelines (PSGs) and scientific consensus, providing robust data that supports regulatory submissions and approvals.
- Establishing Bioequivalence: The data generated from our rAPSD testing is critical for demonstrating bioequivalence between generic and reference products. This ensures that your generic product performs equivalently in-vitro to the brand-name counterpart.
Dissolution Testing
Key Benefits:
- Critical for Low Solubility APIs: Our dissolution testing is particularly valuable for APIs with low solubility, where dissolution rate can significantly impact drug release and bioavailability.
- We also provide a dissolution method approach for highly soluble APIs, capable of detecting differences between test batches against the reference product.
- Comprehensive Formulation Analysis: Dissolution is useful to evaluate the impact of formulation composition, manufacturing processes, and aerosolization on drug release. This holistic approach helps in identifying potential issues early in the development process, saving time and resources.
- Support for In Silico Models: Dissolution outcomes can serve as critical input parameters for in silico models, enhancing the predictive accuracy of drug behavior in the lungs and PK performance.
- Proving Bioequivalence: Our dissolution testing provides essential data to demonstrate that your generic product releases the active ingredient at a rate and extent similar to the reference product.
Our Team
- Our team of experts is at the forefront of inhalation product testing, continuously innovating to provide the most accurate and reliable data.
- Some of Emmace personnel have more than 20 years of expertise in these analytical approaches
- Customized Solutions: We understand that each product is unique. Our testing services are tailored to meet the specific needs of your formulations and devices as well as the patient target group.
