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Handbook of Pharmaceutical Excipients, 7Th Ed. Sample Chapter

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Handbook of Pharmaceutical Excipients, 7Th Ed. Sample Chapter Mannitol 1 Nonproprietary Names the appearance of the lyophilized plug in a vial.(16–18) A pyrogen- BP: Mannitol free form is available specifically for this use. Mannitol is used in food applications as a bulking agent. JP: D-Mannitol PhEur: Mannitol USP–NF: Mannitol 8 Description Mannitol is D-mannitol. It is a hexahydric alcohol related to 2 Synonyms mannose and is isomeric with sorbitol. Compressol; Cordycepic acid; C*PharmMannidex; E421; Mannitol occurs as a white, odorless, crystalline powder, or free- Emprove; Ludiflash; manita; manitol; manna sugar; mannit; D- flowing granules. It has a sweet taste, approximately as sweet as mannite; mannite; mannitolum; Mannogem; Pearlitol. glucose and half as sweet as sucrose, and imparts a cooling sensation in the mouth. Microscopically, it appears as orthorhom- 3 Chemical Name and CAS Registry Number bic needles when crystallized from alcohol. Mannitol shows polymorphism.(19) D-Mannitol [69-65-8] 4 Empirical Formula and Molecular Weight 9 Pharmacopeial Specifications C6H14O6 182.17 See Table I. See also Section 18. 5 Structural Formula 10 Typical Properties Compressibility see Figure 1. SEM 1: Excipient: mannitol; manufacturer: Merck; magnification: 50Â; M voltage: 3.5 kV. 6 Functional Category Lyophilization aidplasticizing agent; sweetening agent; tablet and capsule diluent; tonicity agent. 7 Applications in Pharmaceutical Formulation or Technology Mannitol is widely used in pharmaceutical formulations and food products. In pharmaceutical preparations it is primarily used as a diluent (10–90% w/w) in tablet formulations, where it is of particular value since it is not hygroscopic and may thus be used with moisture-sensitive active ingredients.(1,2) SEM 2: Excipient: mannitol; manufacturer: Merck; magnification: 500Â; Mannitol may be used in direct-compression tablet applica- voltage: 3.5 kV. tions,(3,4) for which the granular and spray-dried forms are available,(5) or in wet granulations.(6,7) Granulations containing mannitol have the advantage of being easily dried. Specific tablet applications include antacid preparations, glyceryl trinitrate tablets, and vitamin preparations. Mannitol is commonly used as an excipient in the manufacture of chewable tablet formulations because of its negative heat of solution, sweetness, and ‘mouth feel’.(7,8) It is also used as a diluent in rapidly dispersing oral dosage forms.(9,10) Mannitol has been used to prevent thickening in aqueous antacid suspensions of aluminum hydroxide (<7% w/v). It has also been used as a plasticizer in soft-gelatin capsules, as a component of sustained-release tablet formulations,(11) as a carrier in dry powder inhalers,(12,13) and as a diluent in rapidly dispersing oral dosage forms.(14,15) In lyophilized preparations, mannitol (20–90% w/w) has been used as a carrier to produce a stiff, homogeneous cake that improves 479 480 Mannitol SEM 3: Excipient: mannitol powder; manufacturer: SPI Polyols Inc.; lot no: Table I: Pharmacopeial specifications for mannitol. 3140G8; magnification: 100Â. Test JP XV PhEur 7.4 USP35–NF30 Identification þþþ Characters — þ — Appearance of þþ— solution Melting range 166–1698C 165–1708C 164–1698C Specific rotation þ1378 to þ1458 þ238 to þ258 þ1378 to þ1458 Conductivity – 20 mSÁcmÀ1 — Acidity þ — þ Loss on drying 0.3% 0.5% 0.3% Chloride 0.007% — 0.007% Sulfate 0.01% — 0.01% Arsenic 1.3 ppm — 1 ppm Lead – 0.5 ppm — Nickel þ1 ppm — Heavy metals 5 ppm — — Reducing sugars þ0.2% þ Residue on 0.10% — — ignition Related — þ — substances SEM 4: Excipient: mannitol granular; manufacturer: SPI Polyols Inc.; lot Bacterial — 4 IU/g(b) — no: 2034F8; magnification: 100Â. endotoxins(a) 2.5 IU/g(c) Microbial — 100 cfu/g — contamination Assay (dried 98.0% 98.0–102.0% 96.0–101.5% basis) (a) Test applied only if the mannitol is to be used in the manufacture of parenteral dosage forms. M (b) For parenteral preparations having a concentration of 100 g/L or less of mannitol. (c) For parental preparations having a concentration of more than 100 g/L of mannitol. 100 90 80 70 60 50 Density (bulk) 0.430 g/cm3 for powder; 40 3 0.7 g/cm for granules. 30 Density (tapped) Pearlitol 300DC 3 Pearlitol 400DC 0.734 g/cm for powder; crushing strength (N) Tablet 20 Pearlitol 500DC 0.8 g/cm3 for granules. Density (true) 1.514 g/cm3 10 Dissociation constant pK = 13.5 at 188C a 0 Flash point <1508C 0 10 20 30 40 50 60 70 80 90 100 Flowability Powder is cohesive, granules are free flowing. Compression force (kN) Heat of combustion 16.57 kJ/g (3.96 kcal/g) Heat of solution À120.9 J/g (À28.9 cal/g) at 258C Melting point 166–1688C Figure 1: Compression characteristics of granular mannitol (Pearlitol, Moisture content see Figure 2. Roquette Fre`res). Tablet diameter: 20 mm. Lubricant: magnesium stearate 0.7% w/w for Osmolarity A 5.07% w/v aqueous solution is isoosmotic with Pearlitol 400 DC and Pearlitol 500 DC; magnesium stearate 1% w/w for serum. Pearlitol 300 DC. Particle size distribution Pearlitol 300 DC: maximum of 0.1% greater than 500 mm and Average particle diameter is 250 mm for Pearlitol 300 DC, minimum of 90% greater than 200 mm in size; 360 mm for Pearlitol 400 DC and 520 mm for Pearlitol 500 Pearlitol 400 DC: maximum of 20% greater than 500 mm and DC.(20) See also Figure 3. minimum of 85% greater than 100 mm in size; 20 Refractive index n D = 1.333 Pearlitol 500 DC: maximum of 0.5% greater than 841 mm and Solubility see Table II. minimum of 90% greater than 150 mm in size. Specific surface area 0.37–0.39 m2/g Mannitol 481 1.00 12 3428 3372 2972 2985 2949 3258 2903 Sorption equilibrium moisture 1431 10 Desorption equilibrium moisture 0.75 1286 1042 8 0.50 6 Intensity (KM units) 0.25 4 0.00 Moisture content (%) 4000 3000 2000 1000 0 Wavenumbers/cm–1 2 Figure 4: Infrared spectrum of mannitol measured by diffuse reflectance. Adapted with permission of Informa Healthcare. 0 23 33 43 52 57 67 75 100 1.5 0.6 Relative humidity (%) 2245 2415 Figure 2: Sorption–desorption isotherm for mannitol. 1674 100 0.0 1og(1/R) 80 1498 2168 [2nd deriv. log(1/R)] 1686 2123 × 2452 M 2082 2261 60 1000 −1.5 −0.2 1100 1300 15001700 1900 2100 2300 2500 Median size = 88 µm Wavelength/nm 40 Figure 5: Near-infrared spectrum of mannitol measured by reflectance. Weight oversize (%) necessary may be autoclaved repeatedly with no adverse physical or 20 chemical effects.(22) In solution, mannitol is not attacked by cold, dilute acids or alkalis, nor by atmospheric oxygen in the absence of catalysts. Mannitol does not undergo Maillard reactions. The bulk material should be stored in a well-closed container in a 0 0 40 80 100 160 200 cool, dry place. Particle diameter (µm) Figure 3: Particle size distribution of mannitol powder. 12 Incompatibilities Mannitol solutions, 20% w/v or stronger, may be salted out by Table II: Solubility of mannitol. potassium chloride or sodium chloride.(23) Precipitation has been Solvent Solubility at 208C reported to occur when a 25% w/v mannitol solution was allowed to contact plastic.(24) Sodium cephapirin at 2 mg/mL and 30 mg/mL Alkalis Soluble concentration is incompatible with 20% w/v aqueous mannitol Ethanol (95%) 1 in 83 solution. Mannitol is incompatible with xylitol infusion and may Ether Practically insoluble Glycerin 1 in 18 form complexes with some metals such as aluminum, copper, and Propan-2-ol 1 in 100 iron. Reducing sugar impurities in mannitol have been implicated in Water 1 in 5.5 the oxidative degradation of a peptide in a lyophilized forma- tion.(25) Mannitol was found to reduce the oral bioavailability of cimetidine compared to sucrose.(26) Spectroscopy IR spectra see Figure 4. NIR spectra see Figure 5. 13 Method of Manufacture Mannitol may be extracted from the dried sap of manna and other 11 Stability and Storage Conditions natural sources by means of hot alcohol or other selective solvents. Mannitol is stable in the dry state and in aqueous solutions. It is commercially produced by the catalytic or electrolytic reduction Solutions may be sterilized by filtration or by autoclaving and if of monosaccharides such as mannose and glucose. 482 Mannitol 14 Safety is needed for lubrication of mannitol granulations than is needed for Mannitol is a naturally occurring sugar alcohol found in animals other excipients. and plants; it is present in small quantities in almost all vegetables. Ludiflash (BASF) is a coprocessed excipient used as a tablet filler, Laxative effects may occur if mannitol is consumed orally in large binder, and disintegrant, and contains mainly mannitol with quantities.(27) If it is used in foods as a bodying agent and daily povidone, crospovidone and polyvinyl acetate. It is used for direct compression, and especially for tablets that disintegrate in the ingestion of over 20 g is foreseeable, the product label should bear (32) the statement ‘excessive consumption may have a laxative effect’. mouth. After intravenous injection, mannitol is not metabolized to any Therapeutically, mannitol administered parenterally is used as appreciable extent and is minimally reabsorbed by the renal tubule, an osmotic diuretic, as a diagnostic agent for kidney function, as an about 80% of a dose being excreted in the urine in 3 hours.(28) adjunct in the treatment of acute renal failure, and as an agent to A number of adverse reactions to mannitol have been reported, reduce intracranial pressure, treat cerebral edema, and reduce primarily following the therapeutic use of 20% w/v aqueous intraocular pressure.
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