Novel Oral Dosage Forms : Granules, Sprays & Sachets

GRANULES
 
Orally disintegrating granules (ODG) score highly in regard to ‘opening the packaging’ and ‘integration into everyday routine’.

They are already available for allergy and pain relief. In addition to those ODGs suitable for adults, singular paediatric 4mg granules are suitable for children aged 6 months to 5 years. The granules can either be given directly into a child's mouth, or mixed with a spoonful of cold or room-temperature soft food (eg apple sauce, ice cream, carrots or rice). They can be taken either with or without food, increasing their popularity from those looking for easy administration.

Multi Granule Compression – Measuring Friability/ Compressibility

Granule Compaction Rig

Granule hardness/compressibility testing provides an important measure of physical strength and breakdown characteristics. 

Where granules are irregular in form the testing of single granules is discouraged as repeatability is compromised. In this instance, the testing of a fixed area of sample is advised so as to create an averaging effect over a larger number of granules and therefore improve the quality of the results. 

The Granule Compaction Rig provides a circular testing area in which the sample is contained before compression with a cylinder probe of similar diameter to the testing area. Normally, the maximum force and energy (area under the curve) are taken and used as an indication of hardness/compressibility.

SPRAYABLE DRUGS

Oral sprays deliver drug-containing aqueous droplets to the mouth. 

It is currently a suitable drug delivery method for sufferers of angina, insomnia and multiple sclerosis, and an alternative to injectable insulin formulations for those with diabetes. On actuation, the drug-containing mist is sprayed in the oral cavity and deposits in the buccal and sublingual mucosal membranes. 

Metred Dose Inhaler Rig

Self-administration implies an even greater need for the safe and accurate delivery of any drug. Metering valve systems can be affected by alterations to design and product performance is dependent on the interaction between the elastomeric components and the drug formulation. 

Texture analysis instruments can imitate the downward movement of the finger, measuring the force needed to actuate the spray and administer the dose. A simple TA.XTplus test, using the Metered Dose Inhaler Test Rig which mimics the movement of the finger onto the inhaler, can measure the force needed to administer the dose. 

SACHETS

Sachet/Tube Extrusion Rig
fitted to the TA.XTplus
Texture Analyser

A large proportion of pharmaceutical, cosmetic and personal care products are often produced in sachet or tube portions for quick and convenient use, as well as to facilitate long-term storage. 

Removal of the contents relies on the consumer’s ability to squeeze the packaging, and on the consistency of the product, assuming the aperture of the tube/sachet remains constant. By testing the force required to extrude the contents of a sachet or tube at regular intervals over a long period of time, product developers can analyse changes in a product’s consistency throughout its shelf-life and adapt formulations accordingly. The new attachment also enables manufacturers to assess the suitability of packaging material and its construction.

Assessment of sachet
extrusion characteristics

The Sachet/Tube Extrusion Rig positions the product vertically between two rollers, clamping the closed end at the top with a grip. This grip then pulls the sachet/tube upwards through the rollers, forcing the contents out. The higher the force recorded during this test, the more difficulty a consumer would experience in squeezing out the required amount. As the contents’ consistency is fundamental to effective extrusion, the instrument can help manufacturers create optimum product formulations.

Conclusion
 
At Stable Micro Systems, we see the laboratory as the heart of the pharmaceutical operation.

It is crucial, from discovering new drugs and formulations to testing their efficacy and the final product’s ease of use, as well as securing regulatory compliance. 

If the lab isn’t functioning optimally, there may be a major (and potentially debilitating) impact on all other areas of the business. It is therefore vital not only to attract top employees and to utilise optimal procedures, but also to ensure the lab equipment fulfils all the needs of the business, today and preferably tomorrow.

Despite a generally more optimistic economic climate, capital investment is still being intensely scrutinised and often remains restricted. Demonstrating suitability for use, adaptability, performance and, where possible, futureproofing, can help secure funds, guarantee required functionality and ensure return on investment. 

As a result, multifunctional lab equipment such as the TA.XTplus Texture Analyser is becoming more popular – and in some cases almost a necessity. The ability to test multiple parameters with one instrument is an attractive proposition, as it saves lab space, time, training and expense. Accurate, repeatable and objective analysis of powder handling, textural and mechanical properties must not be underestimated. 

So whether fitting out a completely new lab, updating older equipment or starting the development of new products, leading-edge multifunctional instruments like texture analysers make sense both operationally and financially. Today, the best equipment and protocols in the lab offer the best opportunity for overall commercial success.

A summary of how to perform texture analysis on the alternatives to traditional tablet-form medications using a TA.XTplus Texture Analyser can be viewed in this video...

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We can design and manufacture probes or fixtures for the TA.XTplus texture analyser that are bespoke to your sample and its specific measurement.

Once your measurement is performed, our expertise in its graphical interpretation is unparalleled. Not only can we develop the most suitable and accurate method for the testing of your sample, but we can also prepare analysis procedures that obtain the desired parameters from your curve and drop them into a spreadsheet or report designed around your requirements.

For more information on how to measure texture, please visit the Texture Analysis Properties section on our website.

The TA.XTplus texture analyser is part of a family of texture analysis instruments and equipment from Stable Micro Systems. An extensive portfolio of specialist attachments is available to measure and analyse the textural properties of a huge range of food products. Our technical experts can also custom design instrument fixtures according to individual specifications.

No-one understands texture analysis like we do!

To discuss your specific test requirements click here...