Tablets & Capsules

TC0419

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Tablets & Capsules April 2019 39 NBE Private Label Oral Care • NBE Efferdent • NBE Polident NBE Polident NBE Polident OTC Drugs • NBE Alka Seltzer • NBE Alka Seltzer Plus Contract Manufacturing OTC • Supplements • Beverages Beverages • Cosmetics Cosmetics Cosmetics • Shower & Bath tablets Shower & Bath tablets Shower & Bath tablets • Tablets, Powders & Granulations Tablets, Powders & Granulations Tablets, Powders & Granulations Dietary Supplements ❖ In House Testing & Product Development ❖ Humidity Controlled Environment ❖ Humidity Controlled Environment www.towerlabs.com • Phone (860) 767-2127 • Centerbrook, CT • Clinton, CT • Montague, MI NBE Private Label Oral Care • NBE Efferdent ® • NBE Polident ® OTC Drugs • NBE Alka Seltzer ® • NBE Alka Seltzer Plus ® Dietary Supplements • NBE Airborne ® Contract Manufacturing OTC • Supplements • Beverages • Cosmetics • Shower & Bath tablets • Tablets, Powders & Granulations ❖ In House Testing & Product Development ❖ Humidity Controlled 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References 1. W. J. Jones 3 rd and J. J. Fran- cis. "Softgels: consumer perceptions and market impact relative to other oral dosage forms." Advances in Ther- apy (2000). Vol. 17, No. 5, pages 213-221. 2. Gabriele Reich. "Effect of sorbi- tol specification on structure and properties of soft gelatin capsules." Pharmazeutische Industrie (1996). Vol. 58, pages 941-946. 3. Jeffrey E. Browne. "Dosage Form Options for the Oral Delivery of Liquid Lipid-based Formulations: Key Considerations for Selection, Benefits, Limitations, and Future Prospects." Catalent Pharma. www. catalent.com/index.php/thinking. Xavier Parissaux is global market man- ager, pharma global business unit and Olaf Haeusler is global technical appli- cations specialist, pharma global busi- ness unit at Roquette (630 463 9430, www.roquette.com/pharma). An additional benefit of the lower moisture uptake is that it limits the capsule shell's oxygen permeability, improving stability for drugs sensi- tive to oxidation [3]. Sorbitol-sorbitan solution can be a key ingredient in developing a versa- tile softgel formulation that's well suited to a variety of fill composi- tions, including those designed to solubilize or suspend APIs (such as oil, PEG, and self-emulsifying sys- tems). Its unique properties allow it to not just plasticize softgels efficiently, but also to increase productivity and widen the stability conditions for this sensitive dosage form. T&C tions. Temperature and humidity fluctuations during storage are less likely to over-plasticize the gelatin shell causing softening, stickiness, and cold flow. Storage tests at increased humid- ity levels demonstrate that substitut- ing half of the glycerin in a softgel formulation with sorbitol-sorbitan solution reduces the shell's water uptake and limits its melting tem- perature reduction, as shown in Fig- ure 5. This can help prevent the shell's melting temperature from reaching a minimum temperature below which sticking begins to become a problem. Figure 5 Gelatin lm melting temperature after storage at 50 and 60 percent relative humidity (RH) 80 70 60 50 40 30 20 10 0 Melting temperature (°C) Initial 22°C/50% RH 25°C/60% RH Minimum melting temperature 33% glycerin 16.5% glycerin/16.5% Polysorb

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