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Excipients and Their Attributes in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Isomalt, a relatively new excipient is a mixture of polyols – glucopyranosyl-sorbitol and glucopyranosyl-mannitol – and by varying the relative ratios of the two components in the mixture as well as varying the particle size grades and granular grades, the resulting products are designed to address several formulation and processing challenges. Like the other polyols, isomalt is non-cariogenic, and has a negative heat of solution producing a cooling effect in the mouth. It has a sweetness level about half that of sucrose and is also used in preparations for diabetics because of its low glycemic index. It is used in tablets, capsules, coatings, sachets, and suspensions, and effervescent tablets and can be processed by direct compression and wet granulation depending on the grade. Isomalt is quite compactible, as can be seen in Figure 5.7. It is non-hygroscopic, relatively inert, and quite stable, and therefore makes an ideal filler-diluent-binder regardless of the tablet manufacturing process to be used.
The Rational Use of Dietary Supplements, Nutraceuticals, and Functional Foods for the Diabetic and Prediabetic Patient
Published in Jeffrey I. Mechanick, Elise M. Brett, Nutritional Strategies for the Diabetic & Prediabetic Patient, 2006
Dark chocolate consumption (100 g/day) has been associated with improvements in insulin sensitivity, blood pressure, blood flow, and LDL-c levels [108,109]. Cocoa powder flavorings have also been associated with increased postprandial insulinemia [110]. Experimentally, these clinical findings are thought to be mediated by NO-synthase regulation, immunomodulation, and 1κB/NF-κβ activation [111]. These effects have been attributed to the flavanol class of polyphenols (catechins, epicatechins, and procyanidins) in cocoa products (derived from Theobroma cacao) though over 600 phytochemicals have been identified in dark chocolate. High concentrations of flavanols are also found in tea, grapes, and grapefruit. The total polyphenol content of dark chocolate is approximately 500 mg/100 g and flavanol content is 88 mg/100 g. Moreover, chocolate is a magnesium-rich food (≈ 100 mg/100 g) which could also account for beneficial effects on glycemic control and the cardiovascular system. The sugar content of dark chocolate may be replaced by sorbitol or isomalt to reduce the glycemic effect of diabetic confectioneries, though increased gastrointestinal symptoms, such as flatulence, may be observed [112,113]. Pre-clinical data from rats has also demonstrated that antioxidative activity in cocoa might also decrease cataract formation [114]. Potential adverse effects of dark chocolate include dental caries, obesity, calciuria, and oxaluria [115]. Thus, even with emerging data supporting a potential clinical benefit of dark chocolate on glycemic control and cardiovascular health (evidence level 3), the high fat and high caloric content, as well as unknown optimal dosing, precludes an evidence-based prescription for diabetic patients to eat dark chocolate (grade C: no objection to limited consumption provided body weight, glycemic control, and lipid status are controlled).
Synbiotic supplementation for glycemic status in pregnant women: a meta-analysis of randomized clinical trials
Published in Gynecological Endocrinology, 2021
Cheng Luo, Jinxing Wan, Zichen Rao, Yiming Zhang
The baseline characteristics of the four eligible RCTs were summarized in Table 1. The four studies were published between 2014 and 2018, and the total sample size was 272. There were similar characteristics at baseline. The methods of synbiotic supplementation were different in each RCT. Three included RCTs involved pregnant women with diagnosed diabetes [22,24,30], while the remaining RCT involved pregnant without known diabetes [7]. The detail compositions of synbiotic capsule were different in each study. The study conducted by Nabhani et al. reported L. acidophilus, L. plantarum, L. fermentum, L. gasseri and fructooligosaccharide for 6 weeks [30]. Karamali et al. reported Lactobacillus acidophilus strain T16, L. casei strain T2, and Bifidobacterium bifidum strain T1 plus inulin (HPX) for 6 weeks [22]. Ahmadi et al. reported Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum plus inulin for 6 weeks [24], while Taghizadeh et al. reported Lactobacillus sporogenes, inulin as prebiotic with isomalt, sorbitol and stevia as sweetener for 9 weeks [7].
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].
Design and optimization of a child-friendly dispersible tablet containing isoniazid, pyrazinamide, and rifampicin for treating tuberculosis in pediatrics
Published in Drug Development and Industrial Pharmacy, 2020
Javier Suárez-González, Ana Santoveña-Estévez, Mabel Soriano, José B. Fariña
INH (Acofarma®), PZA (Sygma-Aldrich®), and RFP (Fagron®) have been used as the API to develop a FDC Tablet for TB treatment. The following excipients were used: AcDiSol® (Croscarmellose Sodium, FMC Corp., Philadelphia, PA), Avicel® PH102, (Microcrystalline Cellulose, FMC Corp., Philadelphia, PA), Explosol® (Sodium Starch Glycolate, Blanver, Taboão da Serra, Spain), CompactCel® (Isomalt, sucralose, betadex, carboxymethylcellulose sodium, Biogrund GmbH, Hünstetten, Germany), Luzenac® (talc, Imerys Talc, Paris, France) and CabOSil® (fumed silica, Cabot CorporaFon, Boston, MA). Purified water was obtained from a water purification system (Puranity TU 12, VWR, Radnor, PA).