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Binders in Pharmaceutical Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Pregelatinized starch is classified as modified starch. Chemical and mechanical treatment is used to rupture all or part of the native starch granules. Pre-gelatinization enhances starch cold-water solubility and also improves compactibility and flowability. PGS is marketed as a multifunctional excipient, providing binding, disintegration, good flow, and lubrication. PGS monographs can be found in the United States Pharmacopeia/National Formulary (USP/NF), European Pharmacopeia (Ph. Eur.), and JPE [15]. It is typically used from solution in wet granulation; it can also be dry added, but this reduces efficiency significantly. Furthermore, at 15% to 20%, use levels are usually higher for PGS relative to other binders. PGS is not compatible with organic solvents and thus is used only in aqueous binder systems. While it tends to have high equilibrium moisture levels (Figure 4.2), starch is known to hold water in different states, that is, only a portion of the sorbed water will be available as “free” water. This property can be exploited by using starch as a stabilizer or moisture sequestrant. Partially pregelatinized starch is the most frequently used form of PGS, but fully pregelatinized starch is also available. The degree of pre-gelatinization determines cold water solubility. Commercial partially pregelatinized starch typically has around 20% pregelatinized or water-soluble content. The cold-water soluble part acts as a binder, while the remainder aids tablet disintegration. For this reason, fully pregelatinized starches tend to have higher binder efficiency, but not necessarily good disintegrant properties.
Capsule Shell Manufacture
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Brian E. Jones, Fridrun Podczeck, Paul Lukas
In 2002, R.P. Scherer Technologies, Inc. proposed the use of carrageenan mixtures to produce soft capsules using a standard rotary die machine.66 The film composition was a mixture of iota-carrageenan and a modified starch, which was required to have a hydration temperature <90°C. The mixture ratio of these two materials was critical to produce a wet film with the correct characteristics: a fusion pressure of >207 kPa at a temperature from 25°C to 80°C with a film melting temperature of preferably 4°C to 9°C above its fusion temperature, which is when the films are brought into contact will blend to form a solid structure. The preferred modified starch was a hydroxypropylated acid modified grade. The dry shell w/w composition was iota-carrageenan 12–24%, modified starch 30–60%, plasticizer (glycerin) 10–60%, and a dibasic sodium phosphate buffer 1–4%. It was noted that the sealing of these capsules occurred at a substantially lower pressure than for mammalian gelatin and that this would result in less wear and tear on the machines and in energy cost savings. The iota-carrageenan acts to make the starch film more elastic, resulting in capsules with good mechanical properties. The main difference in the machine settings between these capsules and gelatin is that their ribbon casting and the wedge sealing are carried out at higher temperatures. These capsules are sold under the trademark Vegicaps Soft by Catalent.67 Their advantage over conventional gelatin soft capsules was that they could be filled with materials at significantly higher temperatures. This enabled excipients such as polyethylene glycol 6000, which is solid below 60°C, to be used as an excipient for liquid-filling. In a following patent, Scherer described a method of improving the process of producing films from this mass to accommodate the higher casting temperatures required for iota-carrageenan/starch films.68 The film forming material was prepared and then was chilled and stored if it is not required immediately. When required, this material was transferred to a melt-on-demand device and heated to the correct temperature in 15 to 30 min. These film-forming materials have a high viscosity compared to gelatin, up to 20 MPa s. When ready, it is pumped under pressure into an extrusion device. This could either have the form of a “coat-hanger” die with an extrusion slot or a valved injection wedge. The extruded ribbon is applied to the casting drum at a tilt angle of c. 5°. The system was enclosed, thus reducing water loss compared to a standard spreader box, able to be operated at higher temperatures, up to 90°C, which could be easily regulated.
Effect of formula factors on the properties of HPMC plant hollow capsule film
Published in Drug Development and Industrial Pharmacy, 2021
Huipu Ding, Shulei He, Wenqin Luo, Liping Liu, Sa Wang, Xuhan Chen
Capsule is the main type of drug preparation. The quality of hollow capsule (capsule shell) and its material will directly affect the safety and effect of capsule clinical use [1]. Hollow capsules are mainly divided into gelatin hollow capsules and plant hollow capsules. With the ‘Chinese Pharmacopoeia’ (2020 edition) increasing the number of hollow vegetable capsules (in addition to the existing starch hollow capsules, pullulan and cellulose hollow capsules will be added), indicating that plant hollow capsules will be the development trend of the industry [2]. Compared with gelatin capsule film, the capsule film made of modified starch is stable, not easy to absorb moisture, and does not cross-link with drugs [3]. The key is that starch is cheap, but the mechanical properties and strength of the capsule membrane prepared by starch are low [3]. The capsule film made by pullulan has the advantages of low air permeability (oxygen, carbon dioxide and other gases are almost impermeable), low moisture absorption and high gloss. However, the mechanical strength of the film is not satisfactory, and the price is relatively high [4]. The capsule film made of cellulose has low water content and high chemical stability, which is especially suitable for the filling of herbal medicine products [5]. Its water vapor and oxygen permeability are better than gelatin too [5]. Among the three kinds of plant hollow capsules, hydroxypropylmethylcellulose (HPMC) is the most studied and accepted by the market. In the global hollow capsule Market, the annual growth rate of HPMC hollow capsule is more than 25% [6].
Cassava toxicity, detoxification and its food applications: a review
Published in Toxin Reviews, 2021
Anil Panghal, Claudia Munezero, Paras Sharma, Navnidhi Chhikara
Starch is considered as a multibillion dollar business worldwide and it can be used in several industries. Cassava starch cake with 40% moisture can be used in wafer formation with different shape and size. Wafers have good expansion quality and expand two-three times on frying (Bagalopalan 2002). In the textile industries, oxidized starch (modified starch) is used for dyeing, sizing, and impression of design on fabrics which make the finished textile products look harder, brighter, and with increased weight. Cassava starch is usually chosen over other starches for sizing coarse yarn (wool) and also used as thickening agents in printing inks (Srinivas 2007). In pharmaceutical industries, starch is used as fillers and binding agent for tablets, gelatin capsules, and powder formulations (Singh and Nath 2012). Cassava starch, being cheap, is used as filler in making soap; the particles of soap are mixed with the starch before milling for better shelf life (Tonukari 2004). In this application, the performance of cassava starch is similar to other starches but can be preferred being cheap and high availability in Africa (Tonukari et al.2015).
Design of minocycline-containing starch nanocapsules for topical delivery
Published in Journal of Microencapsulation, 2018
J. M. Marto, L. F. Gouveia, L. M. D. Gonçalves, H. M. Ribeiro, A. J. Almeida
Minocycline hydrochloride (MH), alcohol, pre-gelatinized starch (Starch 1500), wheat starch and corn starch were obtained from Laboratórios Atral S.A. (Portugal). Ethoxydiglycol (Transcutol® CG) and caprylocaproyl macrogol-8 glycerides (caprylocaproyl) (Labrasol®) were a gift from Gattefossé (Lyon, France). Caprylic/capric triglycerides (Miglyol® 812) were a gift from Sasol Olefins & Surfactants GmbH (Hamburg, Germany). Phenoxyethyl caprylate (Tegosoft® XC), PEG-7 glyceryl cocoate (Tegosoft® GC), ethylhexyl stearate (Tegosoft® OS), diethylhexyl carbonate (Tegosoft® DEC), isopropyl myristate (Tegosoft® M) and decyl oleate (Tegosoft® DO) were a kind gift from Evonik Industries AG (Essem, Germany). Pregelatinized modified starch (Instant Pure-Cote® B793) was a kind gift from Grain Processing Corporation (Washington, USA). Modified starches (Pure-Gel® B990, Pure-Gel® B994, Pure-Cote® B790 and Instant Pure-Cote® B793) were a kind gift from Grain Processing Corporation’s (USA). Polyethylene glycol (Lutrol® E 400) was a gift from BASF (Rheim, Germany). Cetrimonium bromide (cetrimide) was a gift from DS Produtos Químicos (São Domingos de Rana, Portugal). Polysorbate 80 (Tween® 80) was obtained from Merck (Kenilworth, USA). Ethanol was obtained from Carlo Erba Reagents (Cornaredo, Italy). Purified water was obtained by reverse osmosis and electrodeionization (Millipore, Elix 3, Oeiras, Portugal) being afterwards filtered (pore 0.22 µm).