Attapulgite 1 Nonproprietary Names BP: Arcapulgite 2 Synonyms Acapulite; Ataclys Amacote, Atagels aapulgsspalyporscites palygorskite; Pharmaor® Regular. 3. Chemical Name and CAS Registry Number Ateapulite (12174-11-7] 4 Empirical Formula and Molecular Weight Aveapulgite is purified native hydrated magnesium aluminum silicate “consisting of the clay mineral palygorskite, with the empirical formula Mg(Alp 5 Feo oSOxa(0H} 4F1,0. 5 Structural Formula See Section 4 6 Functional Category Adsorbent 7 Applications in Pharmaceutical Formulation or Technology Areapulgite is widely used as an adsorbent in solid dosage forms, Colloidal clays (such a atapuigite) absoris considerable amounts of water co form gels and in concentrations of 2-5% wl usually form. oil-in-water emulsions. Activated attapulgite, which is ateapulgite that has been carefully heated to increase its absorptive capacity, is used therapeutically as an adjunct inthe management of dacthea 8 Description Atcapulgite occurs as a light cream colored, very fine powder Particle size ranges depend on the grade and manifactarer, 9 Pharmacopeial Specifications See Table I. See also Section 17. Test 2009 idenicaton Choraces + Acidiy or alkalinity (5% w/v aqueovs wspenion) ——7.0-9.5 ‘drorive copay ar drsone 8 ppm Heavy metals 220 ppm ‘eid nslsble moter ei Water soable motor =05% tos on dying £170% os on ignition 15.0-27.0% 10 Typical Properties AcidityValkalinity pit = 9.5 (5% we aqucous sspension) “nel of repose 372-45." Density 2.2 g/cm! Density (tapped) 0.33 glen?" Flowability 20.9-29.6% (Cart compressibility index)'" Particle sige distribution <2 um in size for powders 2-Sm in sie for aggregate. 11 Stability and Storage Conditions Acaplte can adsorb wate. should be stored in an aiiht 12 Incompatibiliies Anapulgte ay decrease the bjoavailabilty of some drugs such as loperamide" and riboflavin.” Oxidation of hydrocortisone is increased in the presence of artapuleit. 13 Method of Manufacture Artapulgite occurs naturally as the mineral palygorskte 14 Safety Anapulgite is widely used in pharmaceutical formulations and is generally regarded 38 an essentially nontoxic and_nonictant matesial. Its not absorbed following oral administration. In oral preparations, activated attapullite upto 9 gis used in daily divided Goses as an adjunct in che management of ciarehea! LD so (ras, IP) 0.34 g/kg Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection, gloves, and a dust mask are recommended. Attapulgite should be handled in a well- ventilated environment and dust generation should be minimized. When heated to decomposition, atapulgite emits acrid smoke and irritating fumes. 16 Regulatory Status Included in nonparenteral medicines licensed in a number of countries worldwide including the UK and USA. 17. Related Substances Activated attapulgite; magnesium aluminum silicate Activated attepulgite Comments Activated attapulgite is a processed native magnesium ‘aluminum silicate that has been carefully heated to increase ts adsorptive capacity. Monographs for activated atapulgite are included in the BP 2009, USP 32, and other pharmacopeias. The USP 32 also includes 'a-monograph for colloidal activated atapulgite. 18 Comments The EINECS number for attapulgite is 302-243-0, 19° Specific References 1 Viseras C, Lépez Galindo A. Characteristics of pharmaceutical grade phyllosilcate powders. Pharm Dev Technol 2000; S(1} 47-82. 2. Moya SA, Bhargava HIN. Adsorpsion and desorption of loperamide hydrochlocie by activated accapulgtes. Am J Health Syst Pharm 1995; 52; 2816-2818. 3. Kall SAH et. fet of atapulgite onthe bioavalabily of a model Tor dose dug riboflavin) in oman. Drug Deo Ted Phare 198713 369-382 5152 Attopulgite 44 Conejo J eral. Oxidative degradation of hydrocortisone inthe presence ‘of atapalgice ) Pharm Sci 1980; 69: 945-948, 5 Sweeeman SC; ed. Martindale: The Complete Drug Reference, 36th fen. Landon: Pharmaceutical Press, 200951708. 20 General References Anonymous. The silicates: atapugie, Kaolin, Kiselgu, magnesium ‘wslicate, pumice, ale. Int] Pharm Compound 1998; 212: 162-163, Viseras C al Characteristics of pharmaceutical grade phyliosiicate ‘compacts, Pharm Dev Techol 2000; (1 53-58 21° Author A Palmieri 22. Date of Revision 10 February 2009,Bentonite 1 Nonproprietary Names BP: Bentonite JP: Beatonite PhEue: Bentonite USP-NP: Bentonite 2 Synonyms Albagel; bentonitam; F558; mineral soap; Polargel; soap clay; taylorite; Vegi HS; wilkinite. 3 Chemical Name and CAS Registry Number Bentonite [1302-78-9] 4 Empirical Formula and Molecular Weight AlOs4SiO,H,O 359.16 Bentonite is a native colloidal hydrated aluminum silicate consisting mainly of montmorillonite, AlLO,-45i0,-H.0; it may. also contain calcium, magnesium, and iron. The average chemical Analysis is expressed as oxides, see Table I, in comparison with ‘magnesium aluminum silicate Bentonite Magnesiom clin siicote Silicon dioxid 59.92% 61.1% ‘Aluminum oxide 19.70% 93% Mgreslum oxide 153% 137% Fore oxide 296% ose Golem oxide Osa 27% Sedivm oxide 208% 29% Potassium oxide ose 3% 5 Structural Formula ‘The PhEur 6.4 describes bentonite as a natural clay containing a high proportion of montmorillonite, a native hydrated aluminum silicate in which some aluminum and silicon atoms may be replaced by other atoms such as magnesium and iroa, ‘The USP32-NE27 describes bentonite, purified benonie, and bentonite magma in three separate monographs. Bentonite is described as 2 native, colloidal, hydrated aluminum silicate; and purified bentonite is described as a colloidal montmorillonite that hhas been processed (0 remove grit and nonswellable ore compounds: ‘See aleo Section 4 6 Functional Category Adsorbent; stabilizing agent; suspending agent; viscosity increasing Agent 7 Applications in Pharmaceutical Formulation or Technology Bentonite i a naturally occurring hydrated aluminum silicate used. primarily in the formulation of suspensions, gels, and sols, for topical pharmaceutical applications. It is also used to suspend. powders in aqueous preparations and 0 prepare cream bases Containing oil-in-water emulsifying agents, Bentonite may also be used in oral pharmaceutical preparations, cosmetics, and food products, see Section 18, In oral preparations, bentonite, and other similar silicate clays, can be used to adsorb ionic drugs and so retard their release!”~" Adsorbents are also used to mask the taste of certain drugs. See Table I. Bentonite has been investigated as a diagnostic agent for magnetic resonance imaging,” “Therapeutically, bentonite has been investigated as an adsorbent for lithium poisoning." Use Concentration tt) ‘Adserbent (clarying ager) 1020 Emulsion stobiizor 10 ‘Suspending agent 05-50 8 Description Bentonite is a crystalline, claylike mineral, and is available as an ‘odorless, pale buff, or cream to grayish-colored fine powder, which is free from grit. consists of particles about SO-150 um in size ‘long with numerous particles about 1-2 im. Microscopic exam- ination of samples stained with alcoholic methylene blue solution reveals strongly stained blue particles. Bentonite may have a slight ‘earthy taste 9 Pharmacopeial Specifications See Table it. Test JPxv Pheur 64 —_USPS2-NF27 idenifcaion + + Chorecers ; ; = ‘kali, = ; = ‘Microbial it = E1%cb/e = Cooree ports = 205% > 2kw/v suspension) 90-105 = Ewerdyng Soleo% 98.0% __ 99.0-100.5% 10 Typical Properties Acidity/alkalinity pH =3.8-4.2 (4% wly aqueous dispersion) and 3.5-4.0 (10% wiv aqueous dispersion} for Cab-O-Sil MSP. Density (bulk) "0.029-0.042 pier’ Density (tapped) "see Tables Ill, 1V, and V. ‘Melting point 160°C Moisture content see Figure 1.2" Particle size distribution Primary particle size is 7-16 nm. Aerosil forms loose agglomerates of 10-200 yum. See also Figure 2. Refractive index 1.46 Solubility Practically insoluble in organic solvents, water, and. acids, excep: hydrofluoric acid; soluble in hot solucions of alkali hydroxide. Forms a colloidal dispersion with water. For Aerosil, solubility in water is 150 mg/L at 25°C (pH 7} Specific gravity 2.2 Specific surface area 100-400 m°/g depending on grade. See also Tables Il, [Wand V. Several grades of colloidal silicon dioxide are commercially available, which are produced by modifying the manufactur- ing process. The modifications do not affect the silica content,Colloidal Silicon Dioxide 187 librium moisture (7) Grade Specific surface area! Density tapped g/m") neva) 130 130 +25 0.05 1300 130 525 012 200 200 1 25, 0.05 200 200 + 25, 012 4300 300+ 30 0.05 300 30030 oz 380 380+ 30 0.05 380 380 + 30 12 lo) BET meted | rode ic sroce ore Deny Hopped) g/en?) 1 poi (ma °o 10 20-30 4080 6070 80 9D 00 | MS 13025 0.08 so 130 1 23 O04 Relative humidity (6) Ms 200 38 Ooe HS 35225 O04 re 1: Sorption detorption shorn for coloda sicon donde. EHS 390 = 40 0s Faure Sten docen chen cod son dot Bis 390 40 908 (0 BET noth %0 | sate itoring = 7 rode Spectic wrfoce ore" Deny Hopped (a/em"} ge (m?/a) 2% si3 125 +15 0.05 g vis 150220 803, 3 N20, 200 + 30 0.04 2 130 4005 30, O04 3, 40 149 4002.40 004 3 Kis 120 = 20 O04 = 2 20 17020 doe #30 250: 30, 004 20 #2000 140 + 30 022 004 2102 30, 0.08 10) F015 Tos 30, 0.20 2050 NO #30 820 n 010-2030 405060 70 80 90 100 — I8ET meted Particle size (ym) Figure 2: Patil sina dtibton cold ticon donde aoa A 1200, Evonik Degussa Corp. specific gravity, refractive index, color, or amorphous form, Tlowever, particle size, surface areas, and densities are affected. ‘The physical properties of three commercially available colloidal silicon dioxides, Aerosil (Evonik Degussa Corp), Cab-O-Sil (Cabot Corporation}, and Wacker HDK (Wacker-Chemie GmbH) are shown in Tables Il, IV and V, respectively 11 Stability and Storage Conditions Colloidal silicon dioxide is hygroscopic but adsorbs large quantities ‘of water without iquefying. When used in aqueous systems ata pH 0-7.5, colloidal silicon dioxide is effective in increasing the viscosity cof a system, However, at a pH greater than 7.5 the viscosity increasing properties of colloidal silicon dioxide are reduced; and 3¢ pH greater shan 10.7 this ability is lost entirely since the silicon dioxide dissolves to form silicates.""" Colloidal silicon dioxide powder should be stored in a well-closed container 12 Incompatibiliies Incompatible with diethylstilbestrol preparations." 13 Method of Manufacture Colloidal silicon dioxide is prepared by the flame hydrolysis of chlorosilanes, such as silicon tetrachloride, at 1800°C using a hydrogen-oxygen flame. Rapid cooling from the molten state during manufacture causes the product to remain amorphous. 14 Safety Colloidal silicon dioxide is widely used in oral and topical pharmaceutical products and is generally regarded as an essentially ‘nontoxic and nonirrtant excipient, However, intraperitoneal and subcutaneous injection may produce local usu seactions and/or fzanulomas. Colloidal silcon dioxide should therefore not be ‘administered parenterally LD go (rat, IV}: 0.015 /kg"® LDso (ra, orall: 3.16 8/8188 Colloidal Silicon Dioxide 15. Handling Precautions Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye. protection and gloves are recommended, Considered a nuisance dust, precautions should be taken to avoid inhalation of colloidal silicon dioxide. In che absence ofsuitable containment facilites, a dust mask should be worn when handling small quantities of material For larger quantities, dust respirator is recommended, “inhalation of colloidal silicon dioxide dust may cause iritation to the respiratory tract but it is not associated with fibrosis ofthe lungs (silicosis), which can occur upon exposure to crystalline silica. 16 Regulatory Acceptance GRAS listed. Included in the FDA Inactive Ingredients Database (oral capsules, suspensions, and tablets transdermal, rectal, and ‘aginl preparations). Also approved by the FDA asa food additive nd for food contac. Incladed n nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non ‘medicinal Ingredients 17. Related Substances Hydrophobic colloidal silica. 18 Comments Colloidal silicon dioxide is one of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP32-NF2?, the General Chapter 5.8 in PhEur 6.0, along withthe ‘State of Work’ document on the PhEur EDQM website, and also the General Information Chapter 8 in the IP XV. ‘The PhEur 6.0 also contains a specification for hydrated colloidal silicon dioxide. The incidence of microbial contamination of colloidal silicon dioxide is low'"” due to the high production temperatures and inorganic precursor materials, ‘Note that porous silica gel particles may also be used as a plidant, thickener, dispersant and to adsorb moistuze, which may be fan advantage for some formulations. Syloid 244FP meets the USP NF requirements for silicon dioxide, and Syloid 244 FP-BU mects the PhEur and JP requirements for silicon dioxide!"") ‘Another CAS number tha is used for colloidal silicon dioxide is 112945-52.5, "The EINECS number for colloidal silicon dioxide is 231-545-4 ‘The PubChem Compound ID (CID} for colloidal silicon dioxide is 24261 19° Specific References 1 York. Appliccon of powder fire vesting equipment in assessing cffect of elants on lowabty of cofesive pharmaceutical power. Pharm Sei 1975; 64: 1216-1221. 2 Letk CF et a. Tneration of lubvicans and colloidal sca, during inning with excipients itn efecto abetng Pharm Acta Hee 197%; Sai33-39, 3. Lerk CR, Bolhuis GK. Interaction of lubricants and colloidal silica 16 g/kg 15. Handling Precautions Observe normal precautions appropriate o the circumstances and quantity of material handled. Eye protection and gloves are recommended. Adequate ventilation should be provided and dust generation minimized. 16 Regulatory Status Included in the FDA Inactive Ingredients Database (oral granules, solutions, suspensions and tablets; rectal; and topical preparations, vaginal preparations). Included in nonpazenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non: ‘medicinal Ingredients. 17. Related Substances Acrapulgite; bentonite; kaolin; magnesium silicate; magnesium trisilicate; montmorillonite; saponite; tale, ‘Montmorillonite Empirical formula lO; 4SiOx-4H,0 CAS mumber “[1318-93-0] Comments A naturally occurring silicate clay. 18 Comments ‘The FINECS number for magnesium alursinum silicate is 215-478- 8. The PubChem Compound ID (CID) for magnesium aluminum silicate is 3084116, 19° Specific References 1 Polos JA. The mechanisms of thickening by inorganic agents. J Soe (Cosmet Chem 1970; 21: 347-363, 2 Farley CA, Lund W. Suspending agents for excemporancous dispensing valuation’ of alteratives to tapacanth. Pharm J 1976, 216 562-566 3 Ariana AA et al, Ecc of Veegum on the suspending properties of ‘Mucuna gum. Boll Chem Farm 1997; 136: 549-353, 4 MeGinity JW, Tach J Sustained lease applications of montmorillo: nite interaction with amphetamine sulfate] Pharm Sci 1977; 66: 63~ 6 5 MeGinicy JW, Harris MR. Optimization of slowtlease tablet formulators containing montmorillonite |: properties of tables, Drag Dev fed Pharm 1980s 6: 399410 6 Grab FL. etal. Magpesium aluminum scat. Handbook of Pharma: cewical Excipients. Washingson, DC and Landon” American Parma eutial Asosaton and Pharmaceuscal Society of Great Bata, 1986; 166-169. 7 MeGinity JW, Lach J, Intro adsorption of various pharmaceuticals co montmoriliont. Pharm Sei 1976; 68: 896-902. 8 McGinty JW, Harris MR Tncressing dsouton rates poorly soluble rags by adsorption to montmorillonite: Drag Dev hed Pharr 1980; 6 348 9 Varley AB. The generic inequivalence of drugs. Am Med Assoc 1968; 206; 1745-1748 10. Wagner JGet al. in vivo and in iro availabilty of commercial warfarin, tablets. J Pharm Sei 1971; 60: 666-877 11. Mange K. The desorpoon of medicinal substances from adsorbent in coral pharmaceutical suspensions. Acta. Pharmacol Toxicol 1971; 29tSuppl 3) 81-87. 12 Pongjanyakal Tr al, Infuence of magnesia aluiniom siete on theological, lease and permeation characteris of iloenac sodium aqueous gels in eto. J Pharm Pharmacol 2008; 87: 429-434 13. Sakai K, Moriguchi K Efe of magnesium luminosleate adminis tered o pregnant mice on pre-and postnatal development of offspring. ‘Oyo Yoke 1975; 9: 703 14 Sweet DN, ed. Registry of Toxic fects of Chemical Substances CGrcinnai OS Deparment of Heath 1987. 20 General Reference: [RT Vanderbilt Co ne. Technical Ineratare: Vegun the versatile ngreint for pharmaceutical formulations, 1992. ‘Wai eral. Applications of the montsorilonits in tablet making. J Pharm Sei 1966; $5: 1244-1248. Yokoi Het al. [fe of magnesium aluminosilicate on flidity_ of pharmaceutical powders.) J Pharm Soc Jpn 1978; 98: 418-425lin Tapanese 21° Author A Palmieri 22. Date of Revision 12 February 2009,402 lagnesium Silicate 19° Specific References 1 Patel H et al. th effet of excipients on the sail of levosheoxine sodium pentahydrae tables. Int Pharm 2003; 264: 35-43, 2. Kink RE Ochmer DE. Encyclopedia of Chemical Technology, th vol 1s New York Wiley, 1995107 3 Tugel TK ef al Solid state interaction of magnesium oxide and ibuprofen to form asa. Pharm Res 1989; 69} 804-808, 4 Nada AH et an stro adsorption of mepyramine maleate onto some ausorbents and anacis nt} Phars 1999, 58: 175-179. Khai $A et al The vir adsorption of ome abiotcs on antacid Pharmazie 1976; 31. 105-108 6 Naggar VE et al The in-vitro adsorption of some ansheumatics on antacids, Pharmacie 1976, 31: 461-465. Singh A, Mal H. Adsorption of atropine sulfate and hyoscyamine Iydrobromice by various sntacis. Aets Pharm Technol 1979 253) 217-274, 8 Iuagi MA, Aloko KS, Adsorption of paracetamol and chloroquine phosphate by some antacids. J Pharm Pharmacol 1982; 44 655-558. 9. Monkiouse BC, Tach Jl. Drap-Excipient Interactions. Ca] Pharm Ser 1972; 7: 29-46 10. Shanghai NM et al. Matex al Ind Pharm 1990; 16: 1955-1961 11. Rica Feral Formation of controled release drug preparations with antacid effect, Pharmacie 1996, (May): 323-327 12, Race Le al tect of eudragit type polymers on the drug release fom magnesium oxide granules produced by laboratory fication. Drug Det Ind Phar 1995; 2418 2085-2096, 13 Nagavi BG ea. Sold phase interaction of phenobarbitone sodium with sme adjuvants Indian J Pharm Sei 1983, 45-78-17 14 Dicey Ph Mefinay JC. Drug-amtacd neractons. asesment of clinalimporance. Drug Intell Clin Pharm 1987; 21 607-617. of salbutamol slfate, Drug Dev 15. Takahashi He al. Effect of magnesium oxide on enichlormethiazide bioavailability. J Pharm See 1985; 74: 862-865. 16 Remon JP eta. Ineraction of antacids with anti-arhythmies, Pact 5 Effect of aluminum hydroxide and magnesium oxide on te bioaail ability of quiaidine, procainamide, and propranolol in dogs. Arzne ‘mized Forschung 1983; 33(1): 117-120. 17 Jain G, Kakkar A. Ingeracton of diazepam with excipients in binary power form. Indian Drugs 19925 29 Jah 453-454 18 Yong, CS et al. Physicochemical characterization and evaluation of buccal adhesive tables conraising omeprazole, Drug Dev Ind Pharm 2001, 2715). 447=45. 19 Kirk RE, Othmer DF. Encyclopedia of Chemical Technolog, 4th edn, vol 15: New Yor Wiley, 1995, 703-707. 20. Health and Safety Executive, FHAQ2005; Workplace Exposure Limits Sudbury: HSE Books, 2005 (updated 2007). hapulwawse govaki coshltableL pf accessed 5 February 2003). 21 Food Chemicals Codex, 6th eda.” Bethesda, MD: United Saces Pharmacopeia, 2008; $63, 20 General References 21° Author AM Campeta 22. Date of Revision 5 February 2008. 1 Magnesium Silicate 1 Nonproprietary Names JP: Magnesium Silicate USP.NF: Magnesium Silicate 2 Synonyms E553as synthetic magnesium silicate 3 Chemical Name and CAS Registry Number Silicic acid, magnesium sale (1343-88-0] 4 Empirical Formula and Molecular Weight MgO SiOy-xH0 See also Sections 5 and 17. 5 Structural Formula. Magnesium silicate is a compound of magnesium oxide and silicon dioxide, Se also Section 17. The JP XV states that magnesium silicate contains not ess than 45.0% of silicon dioxide (SiO, molecular weight 60.08) and not less than 20.0% of magnesium oxide (MgO: 40.30), andthe ratio of| percentage (%) of magnesium oxide to silicon dioxide is not less than 2.2 and not more than 2.5 "The USP32-NF27 describes magnesium silicate as a compound ‘of magnesium oxide (MgO) and silicon dioxide (SiO) chat contains rot less than 15.0% of MgO) and not less than 67.0% of SiOs calculated om the ignited basis 6 Functional Category Anticaking agent; glidant. 7 Applications in Pharmaceutical Formulation or Technology ‘Magnesium silicate is used in oral pharmaceutical formulations and. food products asa glidant and an anticaking agent. 8 Description ‘Magnesium silicate occurs as an odorless and tasteless, fine, white colored powder that is free from grittiness 9 Pharmacopeial Specifications See Table 10 Typical Properties Moisture content Magnesium silicate is slightly hygroscopic. Solubility Practically insoluble in ethanol (95%), ether, and water 11 Stability and Storage Conditions ‘Magnesium silicate should be stored in a well-closed container in a cool, dry place.Magnesium Silicate 403, Test PY USPS \dentfeation + pH (10% oqueous suspension) 70108 Coon drying = 15% Solsbie sats 0029 30% Chior 20.058% S Free alka : + Heavy metas 30 pom 2 20u8/8 ‘nent =5ppm = Sole =0de% - Loss on ignition =30% = 15% Fluoride = 100m lod = 0.001% ‘Aeidconsoning copaciy : S foto o SiOat0 MgO 22.25 2545 ‘Assoy for MgO 320.0% 215% ‘ssoy for Sin 345.0% Bare 12. Incompatibilities ‘Magnesium silicate may decrease the oral bioavailability of drugs such as mebeverine hydrochloride," sucralface, and tetracycline, via chelation or binding, when they are taken cogether. The dissolution rate of folic acid,” erythromycin stearate,” paraceta- ‘mol and chloroquine phosphate may be retarded by adsorption ‘onto magnesium silicate, Antimicrobial peeservatives, such as parabens, may be inactivated by the addition of magnesium silicate"! ‘Magnesiam silicate is readily decomposed by mineral acids 13. Method of Manufacture ‘Magnesium silicate may be prepared from sodium silicate and ‘magnesium sulfate. The silicate also occurs in nature asthe minerals ‘eerschaum, parasepiolite, and sepiolite 14 Safety Magnesium silicate is used in oral pharmaceutical formulations and is generally rogarded as an essentially nontoxic and nonirritant material Orally administered magnesium silicate is neutralized in the stomach to form magnesiuim chloride and silicon dioxide; some ‘magnesium is absorbed. Caution should be used when greater than ‘SO mEq of magnesium is given daily co persons with impaired renal function, owing tothe risk of hypermagnesemia. Reported adverse effects include the formation of bladder and renal calculi following the regular use, for many years, of magnesium silicate as an antacid.” 15 Handling Precautions ‘Observe normal precautions appropriate to the circumstances and, «quantity of material handled. Eye protection is recommended. 16 Regulatory Acceptance GRAS listed. Accepted for ase as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral cables) Included ia the Canadian List of Acceptable Nonmedicinal Ingredients 17. Related Substances Magnesium aluminum silicate; magnesium metailicate; magnesium ‘orthosilcare; magnesium trisilicate tale metasiicate Comments Magnesium metasilicace (MgSiOs) occurs in nature as ‘the minerals clinoenstatite,enstatite, and protoensttite. ‘Mognesium orthositicate Comments Magnesium orthosilicate (Mg:SiO,) oceurs in nature 135 the mineral forsterite 18 Comments [A specification for magnesium silicate is contained in the Food Chemicals Codex (ECC), “The EINECS number for magnesium silicate ie 215-681-1. The PubChem Compound 1D (CID) for magnesium silicate includes 518821 and 14936, 19° Specific References 1 ALGohary OMN. An ie sro study of the interaction between mebeverine hydrochloride and magnesium tnslicate powder, Int J Pharm 1951; 672 89-95, 2. Iwuagiru MA, Jideonwo A. Preliminary investigations int the in-vitro interaction of fli acid with magnesia trsieate and edible cay Tad J harms 1990; 65: 63-67, 3. Arayne MS, Sultana 1395; 48: 599-602, 4 Twuagura MA, Aloko KS. Adsorption of paracetamol and chloroquine ‘Phosphate by some antacids. J Pharm Pharmacol 1992; 44: 685-658, 5 Alwood MC. The adsorpion of exters of phydronyBemve ac by ‘magnesium tsieate ne] Pharm 1982; 11: 101-107. {6 Jockes AM eral Muhple renal sca calcul. By Med J 1973; 1: 146- 17, 7 Leviton DA et al. Silca stones in the urinary bladder, Lancet 19825: 04-708 8 Hood Chemicals Codes, 6th eda, Pharmacopesa, 2008; 567 ‘Eytheomycin-anaci interaction. Pharmacie Bethesda, MD: United Seates 20 General References Anonymous. The silicates: aapulgite, kaolin, kistelguhs, magnesium ‘riicte, pumice, tale. Int J Pharmetcent Composed 1998; 202) 162 163, 21° Author A Palmieri 22 Date of Revision 10 February 2009.