Measure the mechanical properties of pharmaceutical and medical products

The measurement of both texture and mechanical properties in pharmaceutical and medical products assumes a critical role driven by the imperative of product stability, consumer acceptance, and safety within the healthcare industry. Achieving these objectives is particularly challenging in the development of new excipients and drug delivery systems, as their effectiveness and cost benefits can be compromised by quality control issues during manufacturing. To address this, manufacturers must rigorously and scientifically assess any potential alterations in product structure and characteristics throughout formulation, processing, and distribution phases. Texture analysis emerges as a pivotal tool, providing reliable and actionable test data pertaining to the physical quality of active ingredients, inactive ingredients, and finished products, including packaging for sterile items, tablets, tablet coatings, gels, and transdermal delivery systems.

In addition, the realms of Tissue Engineering and Regenerative Medicine research heavily rely on the mechanical function of engineered tissues as a primary endpoint for the successful regeneration of biological tissues. Characterising and comparing tissue function to initial benchmark standards are essential steps in establishing quality control criteria for the next generation of healthcare innovations. The scientific measurement of both texture and mechanical properties in pharmaceutical and medical products serves as an indispensable practice that ensures product quality, efficacy, and the advancement of healthcare solutions.

The use of a Texture Analyser in the pharmaceutical and medical industry is crucial for ensuring product efficacy, safety, and regulatory compliance and provides vital insights and advantages:

• R&D and innovation: In the formulation and design phase, Texture Analysers help researchers understand the effects of various ingredients or materials on product texture and performance, paving the way for innovative solutions.
• Quality control and consistency: In the pharmaceutical industry, consistency is vital. Regular texture and physical property assessments ensure that batches of products, from tablets to topical creams, maintain consistent properties, ensuring patient safety and therapeutic consistency.
• Implant materials testing: For medical implants like stents, pacemakers, or joint replacements, understanding material properties helps predict in-body performance and longevity.
• Packaging performance: Child-resistant caps, blister packs, or auto-injector devices must function consistently and effectively to ensure safety and proper dosing.
• Claims substantiation: If a wound dressing claims to provide "superior adhesion" or a gel promises "fast absorption," a Texture Analyser can offer empirical data to back up these claims, enhancing product credibility.
• Regulatory compliance: Regulatory bodies often require specific tests and data to ensure product safety, efficacy, and consistency. Texture Analysers can provide the quantitative data necessary for regulatory submissions, audits, and approvals.
• Comparative analysis: Benchmarking against competitor products can provide insights into market positioning and potential areas for differentiation.
• Shelf-life testing: Over time, products may change in consistency or mechanical properties, indicating potential degradation or stability issues.

In summary, the use of a Texture Analyser in the pharmaceutical and medical industry ensures that products and devices are not only safe and effective but also consistent and user-friendly. This rigorous quantification of properties is integral for patient outcomes, regulatory compliance, and the overall reputation of manufacturers in these critical sectors.

The physical properties of pharmaceutical and medical products can significantly impact their performance, stability, and user experience. Here are some of the key texture and mechanical properties that can be measured for pharmaceutical and medical products:

By understanding and optimising these properties, pharmaceutical companies and medical device manufacturers can ensure that their products are effective, safe, and user-friendly. Texture Analysers provide the quantitative data needed to make informed decisions during the product development process.

Whether its providing the solution for Reckitt Benkiser to measure their alginate raft strength, a means of characterising Allergan Pharmaceuticals soft gelatin capsule dosage form or offering a method for Aprecia Pharmaceuticals to measure tablet dispersion properties, a Texture Analyser is adaptable and flexible in its application to measure the bespoke mechanical properties of your product and then enable its quality to be controlled in your manufacturing to guarantee consistency and customer satisfaction.

With deep expertise in pharmaceutical and medical product mechanical analysis, we’re well equipped to support innovation in this sector – just ask our customers.

A wide range of probes and attachments an be integrated with our instruments, allowing testing to be precisely adapted to the material or product under evaluation. Applications include compression tests to compare tablet hardness and failure properties, burst tests to assess capsule rupture force or adhesion testing to measure mucoadhesive/bioadhesion properties. 

As the pharmaceutical industry innovates, so our materials analysis evolves, developing and adapting to provide new test solutions and methodologies for highly specific requirements. When a suitable solution did not already exist, we developed one – examples include the Tablet Disintegration Rig, Capsule/Loop Tensile Rig, and Granule Compaction Rig, all of which are part of our growing portfolio of Community Registered Designs.

The examples provided illustrate a selection of specialised attachments and commonly performed measurements within this application area. This list is not exhaustive; a wide range of additional options are available for the testing of pharmaceutical and medical products. All instruments in the Texture Analyser range can be used to perform the tests described.

Exponent Connect software includes a comprehensive range of test methods for pharmaceutical and medical products, all instantly accessible at the click of a button. We streamline your texture testing process, ensuring faster access to methods and ready-to-use analysis files for your product properties.

Pharmaceuticals and medical products are ever-evolving sectors with continuous research to improve efficacy, delivery mechanisms, and patient outcomes. Here are some of the newer ingredient and product ideas in pharmaceutical and medical research, development, and production and a typical academic reference to show how the Texture Analyser has already being applied:

As with all healthcare-related topics, the integration of these trends and innovations into the industry involves rigorous testing, regulatory scrutiny, and continuous monitoring for safety and efficacy. The aforementioned innovations provide a glimpse into the future of medicine and the direction in which medical care is heading.

Here is some recent interesting research in pharmaceutical and medical product development using the Texture Analyser:

• Development of a standardized method for measuring bioadhesion and mucoadhesion that is applicable to various pharmaceutical dosage forms
• 3D printed microneedles for anticancer therapy of skin tumours
• Challenges in the development of drug device combination products for biopharmaceuticals
• Texture analysis–a versatile tool for pharmaceutical evaluation of solid oral dosage forms
• 3D printed biodegradable multifunctional implants for effective breast cancer treatment
• A new approach to atopic dermatitis control with low-concentration propolis-loaded cold cream
• Texture Analysis and Bioadhesive of a Hydrogel as Platforms for Herbal Gel in Sports Massage
• Semi-solid extrusion 3D printing ODFs: an individual drug delivery system for small scale pharmacy