Inhalation Drug Product Analysis and Testing

CD Formulation offers analytical testing services for inhalation products including extractables/leachables testing for inhalation sprays, delivery dose homogeneity testing, droplet size testing, and quality studies of excipients. With years of experience in pharmaceutical formulation development, we offer a truly flexible and expert resource in inhalation product testing and development support.

Our Services

CD Formulation offers analytical services for specialized inhalation sprays, and we support inhalation drug product development for a variety of products, such as dry powder inhalers, nebulizers, or soft mist inhalers. We specialize in analytical testing for method development and validation, product performance testing, chemical analysis/impurity content, physical characterization, and moisture content determination.

Services contents

Delivery dose homogeneity testing

Delivery dose uniformity testing is divided into two categories: intra-device and inter-device: multi-dose inhalation spray intra-device delivery dose uniformity, which assesses whether the same product delivers the labeled dose uniformly throughout its life cycle, and it can also be used to assess whether the inhalation spray delivers the total number of doses consistent with the label instructions. Dose uniformity between devices for the same batch of product is used to assess the overall performance of a batch of product, including the prescription, manufacturing process, and delivery device.

• Droplet size testing

Droplet size testing by laser diffraction provides a rapid screening tool that can provide valuable performance data, which is particularly useful in early formulation development.

• Extractables/Leachables testing for inhalation sprays

With our unparalleled expertise and knowledge of the materials used in rubber and plastic inhaler components, we conduct controlled extraction studies to establish extractables/leachables profiles and achieve control of leachables.

• Quality studies of excipients

The quality of excipients has a very important impact on the safety, quality, stability, performance and efficacy of the formulation. In many cases, mere compliance with the medicinal requirements is not sufficient for excipients for inhalation delivery. Given that pharmaceutical excipients for inhalation sprays are high-risk excipients, they should be given special attention. Factors such as contamination, adulteration and inadequate performance of excipients can introduce risk.

Considerations in development

There are three main factors influencing formulation performance: the design of the inhalation device, the nature of the prescription of the inhalation spray, and patient use such as inspiratory airflow and inhalation technique. Therefore, the design and development of inhalation spray products are highly complex endeavors that require holistic consideration of the interplay between prescription, device, and patient.

Advantages of Inhalation Formulations

• Easy to carry and use, good patient compliance when used in combination therapy with 2 drugs.
• Relatively stable drug prescriptions that do not require refrigerated storage or solution formation prior to use.
• Larger doses can be delivered.
• No hand and breathing coordination is required for use, avoiding synergistic difficulties in patient use.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.