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Nonnutritive Dietary Supplements in Pediatrics
Published in Fima Lifshitz, Childhood Nutrition, 2020
Michael B. Zimmermann, Norman Kretchmer
Newborns and children demonstrate a positive response to sweetness that appears to be a reflexive, innate reaction rather than a learned response.16,20 In school-age children, the percent of total calories from sucrose and other simple carbohydrates is estimated to be around 15%.17 Current recommendations are for reducing refined and processed sugars to 10% or less of total calories.18 Sucrose and high fructose corn syrups are the most frequently used nutritive sweeteners in foods and beverages. Fructose and polyols (sorbitol, mannitol, xylitol, and hydrogenated starch hydrolysate) are other nutritive sweeteners that can replace sucrose in foods and produce equivalent sweetness with lower caloric content. Recent reviews of nutritive sweeteners are available.34,35 Nonnutritive sweeteners are defined as substances having less than 2% of the caloric value of sucrose per unit of sweetening capacity.19 Nonnutritive sweeteners are the fastest growing segment of the food additive industry. Because of changing dietary habits and improving product quality, consumption of nonnutritive sweeteners is expected to exceed current levels by more than 50% by the late 1990s.37 Nonnutritive sweeteners include a heterogeneous group of natural and synthetic substances (Table 2). Currently approved nonnutritive sweeteners used in the United States include saccharin, aspartame, and acesulfame K. Cyclamates, alitame, and sucralose are nonnutritive sweeteners currently awaiting FDA approval.19
Capsule Shell Manufacture
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Brian E. Jones, Fridrun Podczeck, Paul Lukas
The move to replace gelatin in soft capsules started in the early 1990s and was stimulated by the need to reduce the costs by finding a cheaper alternative and to avoid the problems caused by bovine spongiform encephalopathy (BSE) and to expand the usage into other fields. Pharmacaps Inc. developed a chewable gelatin-based soft capsule by the addition of a hydrogenated starch hydrolysate.58 This capsule was claimed to be easy to chew and dissolved quickly in the mouth without leaving a sticky residue. An example w/w formulation for the shell was gelatin 32%, glycerin 25%, hydrogenated starch hydrolysate 20%, and water 23%. R.P. Scherer Corporation in 1992 patented the use of soft capsules containing a high-amylose starch.59 They claimed that the capsules had an improved surface finish, did not stick together, had strong seals, were resistant to shape change, and were cheaper to manufacture because of the lower raw material cost. Starches with high amylose content, preferably greater than 90%, were used to substitute up to 85% of the gelatin content. Solutions of gelatin and glycerin and suspensions of starch and glycerin were prepared, blended together, and heated. The capsules were manufactured on standard rotary die machines. The capsule surfaces had a frosted or satin finish and were rougher than gelatin ones, which was why they did not tend to stick together. A special application for gelatin/starch capsules was the subject of a further patent in 1996.60 This was for a capsule to contain medicaments to be applied external or administered by the rectal route. A requirement for this usage is for the patients to be easily able to grip them firmly and thus the surface texture of the capsule shells needed to be modified because standard capsules have a smooth slippery surface. The shell formulations consisted of blends of gelatin types (e.g., hydrolyzed or acetylated), starch derivatives (e.g., high amylose, esterified), polysaccharide thickening agents (e.g., carrageenan gellan gum), thickening agents (e.g., chitosan derivatives, cellulose derivatives), and plasticizers (e.g., polyglycerols, maltitol). An example of a w/w formulation was acetylated gelatin 49.6%, glycerol 26.1%, hydrogenated starch 14.0%, hydrolyzed gelatin 5.5%, and high-amylose starch 4.8%. This formulation was used on a standard soft capsule machine that had die rolls with special shaped cavities: the main body being oval with a tube from one end attached to a round knob-like structure. The medicament is released by turning the “knob,” which breaks off. The knurled surface of the capsules is applied to the films by means of special texturing rollers, which are applied to the outer surface of the ribbons after casting while they are still moldable and before passing between the rotary dies.61
Use of sorbitol as pharmaceutical excipient in the present day formulations – issues and challenges for drug absorption and bioavailability
Published in Drug Development and Industrial Pharmacy, 2019
Ranjeet Prasad Dash, Nuggehally R. Srinivas, R. Jayachandra Babu
Sugar alcohols, because of being produced from their respective aldose sugars, are also known as alditols. These are low molecular weight easily digestible carbohydrates obtained by substituting the aldehyde group with a hydroxyl group [1]. Primarily, sugar alcohols are classified as hydrogenated monosaccharides (sorbitol, mannitol), hydrogenated disaccharides (isomalt, maltitol, lactitol), and mixtures of hydrogenated mono, di, and/or oligosaccharides (hydrogenated starch hydrolysates) [2]. Amongst these sugar alcohols, sorbitol (Figure 1) has gained significant attention in the past few years because of its wide usage as a pharmaceutical excipient and its influence on the disposition and pharmacokinetics of certain drugs. Sorbitol (i.e. d-glucitol) is a six-carbon sugar alcohol that was discovered by a French chemist in the berries of the mountain ash in 1872. It is also found in fresh fruits such as apples, pears, peaches, apricots and nectarines as well as in dried fruits, such as prunes, dates, raisins, and in some vegetables [3]. Chemically, sorbitol can be produced from glucose or sucrose, by hydrogenation at high temperature [4]. Sorbitol can also be produced by bacteria such as Zymomonas mobilis and Candida boidini, by an enzymatic process [5,6].