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Tableting by Design

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K2VITAL®
Tableting by Design Tableting by Design

Tableting is a broad term used to describe methods of compressing a powder formulation into a solid dosage form using a tablet press or tableting machine. Tablet manufacturing can be challenging due to the physical nature of the ingredients and the number of active ingredients present in nutraceutical formulations.

The correct tablet design process is critical in production, improves patient adherence and drives market growth. It’s important to look at all aspects of the process to ensure that the tablet is robust enough to withstand the rigors of ingredient compaction, has a proper shape, taste and is marketable, while considering the global movement toward natural ingredients in the process. Market demands combined with new regulations, such as with TiO2, are bringing attention to ingredient safety and quality.

Undeniably, the perfect design can make or break a tablet … in every way.

The Equipment

Choosing a tableting machine for a production line can be a daunting and stressful task. Consideration for technical aspects like formulation, output capacity and scalability are equally as important as the machine manufacturer and technical service that come with it.

Consulting with an expert early in the planning stages is beneficial and can help to prevent unforeseen circumstances, and obtain tablet design assistance and technical support.

A clear understanding of the three critical parts in the tablet production process: tablet press (the manufacturing machine), granulation (powder, pellet, grain), and punches and dies (tablet press tooling) are imperative to a successful design.

Benefits of Tablet Coatings

Tablet coating not only physically strengthens the tablet but also protects against light and moisture, provides branding/aesthetic recognition, improves swallowability and shelf-life/stability, masks odor or taste, and controls the rate of release.

Tablet Coating Methods

Sugarcoating: Originating in the confectionery industry, sugar coating is one of the oldest processes and still widely used. The process involves the deposition of aqueous sugar solutions onto the surface of the core tablet.

Film Coating: Introduced in the 1950s, film coating is the process of applying a thin layer of fil-forming polymeric material on the tablet core. Advantages include reduced processing times, capacity to include organic solvents, increased process efficiency and output flexibility in the choice of film-forming polymers. Film coatings have also seen a “natural” overhaul with synthetic materials being replaced with natural colorants such as carmine, spirulina or riboflavin.

Compression/Press/Dry Coating is the process by which a fine dry granulation is compressed onto a tablet core. Although traditionally a less popular process, compression coating has gained increased interest in recent years as a means of creating specialized modified-release products.

Microencapsulation is considered to be one of the most innovative techniques. The process involves the application of a relatively thin coating to a small particle of solids, liquids or even gases in a micron dimension. Benefits of tablet microencapsulation include protecting the core materials from moisture, heat, light and air, controlling the rate of release, improving shelf life of the tablet, and improving compatibility between different materials within the same microcapsule.

Enteric Tablet Coating

Enteric coating is a polymer applied to tablets. It serves as a barrier to prevent the gastric acids in the stomach from dissolving or degrading ingredients after ingestion.

Applying enteric coatings to supplements, such as fish oil tablets, helps to prevent the fishy reflux or burping that often follows taking fish oil pills.

TiO2 In Tableting

For more than 100 years titanium dioxide (TiO2) also referred to as E171 (additive number in the food industry), has been widely used for its ability to confer whiteness and opacity on various products in the pharmaceutical, nutraceutical, paint, paper, cosmetic, food and plastic space—just to name a few.

TiO2 performs several important functions that apply to all stages of a product’s lifecycle—from protecting the ingredients, to making a product easier to identify or ingest. With TiO2 being used for pigment, coating and packaging, this has made the product indispensable to manufacturers with top researchers constantly finding new uses for the mineral.

TiO2 is considered an inert and safe material, but with the development of nanotechnologies TiO2 nanoparticles have increased human and environmental exposure, which has put TiO2 nanoparticles under toxicological scrutiny. The regulation discussion, which originated in France more than three years ago, has resulted in a decision to classify titanium as a category 2 suspected carcinogen by inhalation under E.U. regulation. With the now published regulation that will come into effect on Oct. 1, 2021, labeling will be required for every mixture that contains more than 1 percent TiO2.

TiO2 Replacement in Tablet Film Coating

Finding a suitable alternative to TiO2-based coating formulations can be difficult as many alternatives such as carbonates, phosphates and starches don’t provide equal functionality, brightness and opacity. TiO2 also has a higher refractive index and brightness than other white pigments, so even a small amount can significantly influence a product’s appearance. This means that increased amounts of alternative pigments will be required to achieve the same result as with TiO2.

Future of Tablet Design

The customer demand for natural ingredients continues to drive and change the nutraceutical market, as well as the tablet design process. Consumers are requiring that manufacturers not only provide nutritional information but transparency in all ingredients on the label.

The physical aspects and formulation of a tablet design are not the only considerations of a successful end product. For a market demanding natural ingredients, it’s what’s on the inside and outside that count.

As a result, nutraceutical manufacturers are exploring alternatives to critical solid dosage excipients, including flow agents, lubricants, binders, fillers and pigments. TiO2 manufacturers are currently evaluating alternatives to synthetic colors, iron oxides, silicon dioxides, magnesium stearates and talc.

Future tablet designs will require even more due diligence and advancements at every step. Innovation is no longer enough; today’s consumer demands natural innovation and design. NIE

References:

Tablet Coatings Market by Polymer (Cellulosic, Vinyl, Acrylic), Functionality (Delayed Release, Sustained Release), Type (Sugar Coated, Film Coated, Enteric Coated), End User (Pharmaceutical, Nutraceutical), COVID-19 Impact – Global Forecast to 2025.

www.pharmapproach.com/tablet-coating-process-concepts-and-advancements-2/.

www.naturalproductsinsider.com/manufacturing/high-efficiency-tablet-coating-aids-gmp-compliance-supplement-manufacturers Microencapsulation: A promising technique for controlled drug delivery.

M.N. Singh, K.S.Y. Hemant,* M. Ram, and H.G. Shivakumar, www.ncbi.nlm.nih.gov/pmc/articles/PMC3093624/.

www.pharmapproach.com/tablet-coating-process-concepts-and-advancements-2/https://tdma.info/.what-you-should-know-about-eu-titanium-dioxide-regulations/.

Titanium dioxide in our everyday life; is it safe? Matej Skocaj,1 Metka Filipic,2 Jana Petkovic,and Sasa Novak.

www.ncbi.nlm.nih.gov/pmc/articles/PMC3423755/.

https://tdma.info/the-crucial-role-of-titanium-dioxide-in-modern-pharmaceuticals/.

www.biogrund.com/tio2-replacement-in-tablet-film-coating/?lang=en.

Evelyn Reinson is an international marketing manager at ACG, responsible for global marketing strategies of the company’s product range of capsules, films & foils, engineering, and inspection worldwide. For more information, visit www.ACG-world.com.

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