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Green Granulation Utilizing Environmentally Friendly Binders

Concerns about sustainability are leading pharmaceutical and nutraceutical scientists to evaluate processes that are efficient, economical and friendly to the environment. Regulatory changes regarding the use of solvents and their emissions are also directing manufacturers to search out these “green” production processes. Not only should the granulation and tablet production process be environmentally friendly, but the excipients used and the source of the excipients should be considered. Are they from renewable resources? Are they environmentally friendly ingredients?

Global health care relies on the many active pharmaceutical ingredients, vitamins, minerals and herbal products that are delivered to the consumer in the form of tablets and capsules. These active ingredients are often manufactured in powder form, having a fine particle size distribution and poor flowability and compression properties. Often, these active ingredients are a large portion of the tablet or capsule, compounding the problem, since good flowability and compression properties are essential in making the final dosage form. This can make it impossible to manufacture viable tablets or capsules from these powders without using some type of granulation process.

Economical issues are also at the forefront of pharmaceutical and nutraceutical product development. With changes in health care costs, drugs coming off patent and rapidly growing competition, the formulator must consider the cost of all products and processes used in the development of a dosage form.

Roller compaction is an environmentally friendly, economical and easy granulation process. It is not a new technology, but is a re-emerging dry granulation process. The technology has been used for many years for water-sensitive active ingredients, such as analgesics. Some active ingredients may lose potency if they are exposed to water for a long period of time. This becomes a problem for the stability of the drug and the dosage delivered to the consumer. Roller compaction transforms fine powders into flowable granules by compacting and densifying the powder, thus changing the particle size of the granules to ensure effective flow and compression properties. A basic process is to blend the active ingredient and binder together, compress the powder mixture between the roller compaction rolls, mill and screen to desired size, and compress the granules using a tablet press. This process does not use water or organic solvents, so it is ideal for ingredients that are not compatible with water and it is friendly to the environment.

MALTRIN® maltodextrins and corn syrup solids are excellent binders for the roller compaction process. They are functional excipients manufactured from corn, a renewable resource. MALTRIN® products are GRAS (generally recognized as safe) and environmentally friendly ingredients. All of the products in the MALTRIN® carbohydrate line are effective binders in the roller compaction process and will produce strong roller-compacted ribbons and viable tablets. The properties of the roller-compacted ribbons and the resulting tablets will vary depending on the MALTRIN® product selected for the process. MALTRIN® maltodextrins and corn syrup solids are available in a range of DE (dextrose equivalence). As the DE changes, the binding properties will change consequently changing functionality of the roller-compacted ribbons, and also the resulting granules, tablets or capsules. Depending on the hardness, plasticity, etc., desired for the compressed ribbon or tablet, the formulator can select the MALTRIN® product right for the process.

Starches are also used as binders in roller compaction granulation.

Please visit the nutraceutical section of our website to learn more about MALTRIN® maltodextrins and corn syrup solids and PURE-DENT® Corn Starches for roller compaction.

Please contact us for more information on the roller compaction process using MALTRIN® products or if you would like to receive a copy of our poster on this subject.

MALTRIN®, PURE-DENT® and INSTANT PURE-COTE® are registered trademarks of Grain Processing Corporation.