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Peanut oil is used as an excipient in pharmaceutical formula- tions primarily as a solvent for sustained-release intramuscular injections. It is also used as a vehicle for topical preparations and as a solvent for vitamins and hormones. In addition, it has been part of sustained-release bead formulations,(2) nasal drug delivery systems,(3) and controlled-release injectables.(4)

Therapeutically, emulsions containing peanut oil have been used in nutrition regimens, in enemas as a fecal softener, and in otic drops to soften ear wax. It is also administered orally, usually with sorbitol, as a gall bladder evacuant prior to cholecystography.

Peanut oil is also widely used as an edible oil.

Description

Peanut oil is a colorless or pale yellow-colored liquid that has a faint nutty odor and a bland, nutty taste. At about 38C it becomes cloudy, and at lower temperatures it partially solidifies.

Pharmacopeial Specifications

See Table I.

Typical Properties

Autoignition temperature: 4438C Density: 0.915 g/cm3 at 258C Flash point: 2838C

Freezing point: —58C

Hydroxyl value: 2.5–9.5

Interfacial tension: 19.9 mN/m at 258C(5)

Refractive index: n25 = 1.466–1.470

Solubility: very slightly soluble in ethanol (95%); soluble in benzene, carbon tetrachloride, and oils; miscible with carbon disulfide, chloroform, ether, and hexane.

Surface tension: 37.5 mN/m at 258C(5)

Viscosity (dynamic): 35.2 mPa s (35.2 cP) at 378C(5)

Viscosity (kinematic): 39.0 mm2/s (39.0 cSt) at 378C(5)

Stability and Storage Conditions

Peanut oil is an essentially stable material.(6) However on exposure to air it can slowly thicken and may become rancid. Solidified peanut oil should be completely melted and mixed before use. Peanut oil may be sterilized by aseptic filtration or

506 Peanut Oil

by dry heat, for example, by maintaining it at 1508C for 1 hour.(7)

Peanut oil should be stored in a well-filled, airtight, light- resistant container, at a temperature not exceeding 408C. Material intended for use in parenteral dosage forms should be stored in a glass container.

Incompatibilities

Peanut oil may be saponified by alkali hydroxides.

Method of Manufacture

Refined peanut oil is obtained from the seeds of Arachis hypogaea Linne´ (Fam. Leguminosae). The seeds are separated from the peanut shells and are expressed in a powerful hydraulic press. The crude oil has a light yellow to light brown color, and is then purified to make it suitable for food or pharmaceutical purposes. A suitable antioxidant may be added.

Safety

Peanut oil is mildly laxative at a dosage of 15–60 mL orally or of 100–500 mL rectally as an enema.

Adverse reactions to peanut oil in foods and pharmaceutical formulations have been reported extensively.(8–18) These include severe allergic skin rashes(8,9) and anaphylactic shock following consumption of peanut butter.(10) Some workers have suggested that the use in infancy of preparations containing peanut oil, including infant formula and topical preparations, is associated with sensitization to peanut, with a subsequent risk of hypersensitivity reactions, and that such products should therefore be avoided or banned.(8–12) However, the role of pharmaceutical preparations in later development of hypersen- sitivity is disputed since such preparations contain highly refined peanut oil that should not contain the proteins

associated with allergic reactions in susceptible indivi- duals.(13–15)

Peanut oil is harmful if administered intravenously and it should not be used in such formulations.(16)

See also Section 18.

Handling Precautions

Observe normal handling precautions appropriate to the circumstances and quantity of material handled. Spillages of peanut oil are slippery and should be covered with an inert absorbent material prior to disposal.

Regulatory Status

Included in the FDA Inactive Ingredients Guide (IM injections, topical preparations, oral capsules, and vaginal emulsions). Included in parenteral and nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non- medicinal Ingredients.

Related Substances

Almond oil; canola oil; corn oil; cottonseed oil; sesame oil; soybean oil; sunflower oil.

Comments

As a result of the potentially fatal reactions noted in Section 14, certain food products are now commonly labeled with a

statement that they contain peanut oil. A specification for unhydrogenated peanut oil is contained in the Food Chemicals Codex (FCC).

Specific References

Allen A, Padley GH, Whalley GR. Fatty acid composition of some soapmaking fats and oils. Part 4: groundnut (peanut oil). Soap Perfum Cosmet 1969; 42: 725–726.

Santucci E, Alhaique F, Carafa M, et al. Gellan for the formulation of sustained delivery beads. J Control Release 1996; 42: 157–164.

Maitani Y, Yamamoto T, Takayama K, et al. Modelling analysis of drug absorption and administration from ocular, naso-lacrimal duct, and nasal routes in rabbits. Int J Pharm 1995; 126: 89–94.

Matsubara K, Irie T, Uekama K. Controlled release of the LHRH agonist buserelin acetate from injectable suspensions containing triacetylated cyclodextrins in an oil vehicle. J Control Release 1994; 31: 173–180.

Howard JR, Hadgraft J. The clearance of oily vehicles following intramuscular and subcutaneous injections in rabbits. Int J Pharm 1983; 16: 31–39.

Selles E, Ruiz A. Study of the stability of peanut oil [in Spanish].

Ars Pharm 1981; 22: 421–427.

Pasquale D, Jaconia D, Eisman P, Lachman L. A study of sterilizing conditions for injectable oils. Bull Parenter Drug Assoc 1964; 18(3): 1–11.

Moneret-Vautrin DA, Hatahet R, Kanny G, Ait-Djafer Z. Allergenic peanut oil in milk formulas [letter]. Lancet 1991; 338: 1149.

Brown HM. Allergenic peanut oil in milk formulas [letter]. Lancet 1991; 338: 1523.

De Montis G, Gendrel D, Chemillier-Truong M, Dupont C. Sensitization to peanut and vitamin D oily preparations [letter]. Lancet 1993; 341: 1411.

Lever LR. Peanut and nut allergy: creams and ointments contain- ing peanut oil may lead to sensitisation. Br Med J 1996; 313: 299.

Wistow S, Bassan S. Peanut allergy. Pharm J 1999; 262: 709–710.

Hourihane JO, Bedwani SJ, Dean TP, Warner JO. Randomized, double blind, crossover challenge study of allergenicity of peanut oils in subjects allergic to peanuts. Br Med J 1997; 314: 1084– 1088.

Committee on Toxicity of Chemicals in Food. Consumer Products and the Environment: Peanut Allergy. London: Department of Health, 1998.

Anonymous. Questions raised over new advice following research into peanut oil. Pharm J 2001; 266: 773.

Lynn KL. Acute rhabdomyolysis and acute renal failure after intravenous self-administration of peanut oil. Br Med J 1975; 4: 385–386.

Ewan PW. Clinical study of peanut and nut allergy in 62 consecutive patients: new features and associations. Br Med J 1996; 312: 1074–1078.

Tariq SM, Stevens M, Matthews S, et al. Cohort study of peanut and tree nut sensitisation by age of 4 years. Br Med J 1996; 313: 514–517.

General References

Strickley RG. Solubilizing excipients in oral and injectable formula- tions. Pharm Res 2004; 21(2): 201–230.

Citrus pectin; E440; methopectin; methyl pectin; methyl pectinate; mexpectin; pectina; pectinic acid.

Chemical Name and CAS Registry Number

Pectin [9000-65-5]

Empirical Formula and Molecular Weight

Pectin is a high-molecular-weight, carbohydrate-like plant constituent consisting primarily of chains of galacturonic acid units linked as 1,4-a-glucosides, with a molecular weight of 30 000–100 000.

Structural Formula

Pectin is a complex polysaccharide comprising mainly esterified D-galacturonic acid residues in an a-(1–4) chain. The acid groups along the chain are largely esterified with methoxy groups in the natural product. The hydroxyl groups may also be acetylated.

Pectin gelation characteristics can be divided into two types: high-methoxy and low-methoxy gelation, and sometimes the low-methoxy pectins may contain amine groups. Gelation of high-methoxy pectin usually occurs at pH <3.5. Low-methoxy pectin is gelled with calcium ions and is not dependent on the

presence of acid or high solids content. Amidation may interfere with gelation, causing the process to be delayed. However, gels from amidated pectins have the ability to re-heal after shearing.(1)

The USP 28 describes pectin as a purified carbohydrate product obtained from the dilute acid extract of the inner portion of the rind of citrus fruits or from apple pomace. It consists chiefly of partially methoxylated polygalacturonic acids.

Functional Category

Adsorbent; emulsifying agent; gelling agent; thickening agent; stabilizing agent.

Applications in Pharmaceutical Formulation or Technology

Pectin has been used as an adsorbent and bulk-forming agent, and is present in multi-ingredient preparations for the manage- ment of diarrhea, constipation, and obesity;(2) it has also been used as an emulsion stabilizer.(3)

Experimentally, pectin has been used in gel formulations for the oral sustained delivery of ambroxol.(4) Pectin gel beads have been shown to be an effective medium for controlling the release of a drug within the gastrointestinal (GI) tract.(5) It has also been used in a colon-biodegradable pectin matrix with a pH-sensitive polymeric coating, which retards the onset of drug release, overcoming the problems of pectin solubility in the upper GI tract.(6–9) Amidated pectin matrix patches have been investigated for the transdermal delivery of chloroquine,(10) and gelling pectin formulations for the oral sustained delivery of paracetamol have been investigated in situ.(11) Pectin-based matrices with varying degrees of esterification have been evaluated as oral controlled-release tablets. Low-methoxy pectins were shown to have a release rate more sensitive to the calcium content of the formulation.(12) Pectins have been used as a component in the preparation of mixed polymer microsphere systems with the intention of producing con- trolled drug release.(13)

Description

Pectin occurs as a coarse or fine, yellowish-white, odorless powder that has a mucilaginous taste.

Pharmacopeial Specifications

See Table I.

Table I: Pharmacopeial specifications for pectin.

Test USP 28

Identification +

Loss on drying 410.0%

Arsenic 43 ppm

Lead 45 mg/g

Sugars and organic acids +

Microbial limits +

Assay

Methoxy groups 46.7%

Galacturonic acid 474.0%

Typical Properties

Acidity/alkalinity: pH = 6.0–7.2

Solubility: soluble in water; insoluble in ethanol (95%) and other organic solvents.

Stability and Storage Conditions

Pectin is a nonreactive and stable material; it should be stored in a cool, dry place.

508 Pectin

Incompatibilities

—

Method of Manufacture

Pectin is obtained from the diluted acid extract from the inner portion of the rind of citrus fruits or from apple pomace.

Safety

Pectin is used in oral pharmaceutical formulations and food products and is generally regarded as an essentially nontoxic and nonirritant material.

Low toxicity by the subcutaneous route has been reported.(14)

LD50 (mouse, SC): 6.4 g/kg(14)

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. When pectin is heated to decomposition, acrid smoke and irritating fumes are emitted.

Regulatory Status

GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (dental paste; oral powders; topical pastes). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparent- eral medicines licensed in the UK.

Related Substances

—

Comments

Pectin has been used in film-coating formulations containing chitosan and hydroxypropylmethyl cellulose in the investiga- tion of the biphasic drug-release properties of film-coated paracetamol tablets, both in vitro,(15,16) and in vivo.(17) It has been shown that chitosan acts as a crosslinking agent for concentrated pectin solutions.(18)

Pectin gel systems have been used to show the partition and release of aroma compounds in foods during storage.(19)

A specification for pectin is included in the Food Chemical Codex (FCC). In the food industry it is used as an emulsifying agent, gelling agent, thickener, and stabilizer. Cosmetically, it is used as a binder, emulsifying agent and viscosity-controlling agent.

The EINECS number for pectin is 232-553-0.

Specific References

Cybercolloids Ltd. Introduction to pectins: properties. http://www.cybercolloids.net/library/pectin/properties.php (accessed 26 May 2005).

Sweetman SC, ed. Martindale: the Complete Drug Reference, 34th edn. London: Pharmaceutical Press, 2005: 1580.

Lund W, ed. The Pharmaceutical Codex: Principles and Practice of Pharmaceutics, 12th edn. London: Pharmaceutical Press, 1994: 88.

Kubo W, Miyazaki S, Dairaku M, et al. Oral sustained delivery of ambroxol from in-situ gelling pectin formulations. Int J Pharm 2004; 271(1–2): 233–240.

Murata Y, Miyashita M, Kofuji K, et al. Drug release properties of a gel bead prepared with pectin and hydrolysate. J Control Release 2004; 95(1): 61–66.

Sriamornsak P, Nunthanid J, Wanchana S, Luangtana-Anan M. Composite film-coated tablets intended for colon-specific delivery of 5-aminosalicylic acid: using deesterified pectin. Pharm Dev Technol 2003; 8(3): 311–318.

Liu L, Fishman ML, Kost J, Hicks KB. Pectin-based systems for colon-specific drug delivery via oral route. Biomaterials 2003; 24(19): 3333–3343.

Tho I, Sande SA, Kleinebudde P. Disintegrating pellets from a water-insoluble pectin derivative produced by extrusion/spheroni- sation. Eur J Pharm Biopharm 2003; 56(3): 371–380.

Chourasia MK, Jain SK. Pharmaceutical approaches to colon targeted drug delivery systems. J Pharm Pharm Sci 2003; 6(1): 33–

66.

Musabayane CT, Munjeri O, Matavire TP. Transdermal delivery of chloroquine by amidated pectin hydrogel matrix patch in the rat. Ren Fail 2003; 25(4); 525–534.

Kubo W, Konno Y, Miyazaki S, Attwood D. In situ gelling pectin formulations for oral sustained delivery of paracetamol. Drug Dev Ind Pharm 2004; 30(6): 593–599.

Sungthongjeen S, Sriamornsak P, Pitaksuteepong T, et al. Effect of degree of esterification of pectin and calcium amount on drug release from pectin-based matrix tablets. AAPS Pharm Sci Tech 2004; 5(1): E9.

Pillay V, Danckwerts MP, Fassihi R. A crosslinked calcium- alginate–pectinate–cellulose acetophthalate gelisphere system for linear drug release. Drug Delivery 2002; 9(2): 77–86.

Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 2825–2826.

Ofori-Kwakye K, Fell JT. Biphasic drug release from film-coated tablets. Int J Pharm 2003; 250(2): 431–440.

Ofori-Kwakye K, Fell JT. Leaching of pectin from mixed films containing pectin, chitosan and HPMC intended for biphasic drug delivery. Int J Pharm 2003; 250(1): 251–257.

Ofori-Kwake K, Fell JT, Sharma HL, Smith AM. Gamma scintigraphic evaluation of film-coated tablets intended for colonic or biphasic release. Int J Pharm 2004; 270(1–2): 307–313.

Marudova M, MacDougall AJ, Ring SG. Pectin–chitosan inter- actions and gel formation. Carbohydr Res 2004; 339(11): 1933–

1939.

Hansson A, Leufven A, van Ruth S. Partition and release of 21 aroma compounds during storage of a pectin gel system. J Agric Food Chem 2003; 51(7): 2000–2005.

General References

Lofgren C, Walkenstrom P, Hermansson AM. Microstructure and rheological behavior of pure and mixed pectin gels. Biomacro- molecules 2002; 3(6): 1144–1153.

BP: Yellow soft paraffin JP: Yellow petrolatum PhEur: Vaselinum flavum USP: Petrolatum

Synonyms

Merkur; mineral jelly; petroleum jelly; Silkolene; Snow white; Soft white; yellow petrolatum; yellow petroleum jelly.

Chemical Name and CAS Registry Number

Petrolatum [8009-03-8]

Empirical Formula and Molecular Weight

Petrolatum is a purified mixture of semisolid saturated

Description

Petrolatum is a pale yellow to yellow-colored, translucent, soft unctuous mass. It is odorless, tasteless, and not more than slightly fluorescent by daylight, even when melted.

Pharmacopeial Specifications

See Table II.

Table II: Pharmacopeial specifications for petrolatum.

hydrocarbons having the general formula C H , and is

n 2n+2

obtained from petroleum. The hydrocarbons consist mainly of branched and unbranched chains although some cyclic alkanes and aromatic molecules with paraffin side chains may also be present. The USP 28 and PhEur 2005 material may contain a suitable stabilizer (antioxidant) that must be stated on the label. The inclusion of a stabilizer is not discussed in the JP 2001 monograph.

Refractive index: n60 = 1.460–1.474

Emollient; ointment base.

Solubility:

practically insoluble in acetone, ethanol, hot or cold

Applications in Pharmaceutical Formulation or Technology

Petrolatum is mainly used in topical pharmaceutical formula- tions as an emollient-ointment base; it is poorly absorbed by the skin. Petrolatum is also used in creams and transdermal formulations and as an ingredient in lubricant formulations for medicated confectionery together with mineral oil.

Therapeutically, sterile gauze dressings containing petrola- tum may be used for nonadherent wound dressings or as a packing material.(1) Petrolatum is additionally widely used in cosmetics and in some food applications. See Table I.

Table I: Uses of petrolatum.

Use Concentration (%)

Emollient topical creams 10–30

Topical emulsions 4–25

Topical ointments Up to 100

ethanol (95%), glycerin, and water; soluble in benzene, carbon disulfide, chloroform, ether, hexane, and most fixed and volatile oils.

Viscosity (dynamic): the rheological properties of petrolatum are determined by the ratio of the unbranched chains to the branched chains and cyclic components of the mixture. Petrolatum contains relatively high amounts of branched and cyclic hydrocarbons, in contrast to paraffin, which accounts for its softer character and makes it an ideal ointment base.(2–5)

Stability and Storage Conditions

Petrolatum is an inherently stable material owing to the unreactive nature of its hydrocarbon components; most stability problems occur because of the presence of small quantities of impurities. On exposure to light, these impurities may be oxidized to discolor the petrolatum and produce an undesirable odor. The extent of the oxidation varies depending upon the source of the petrolatum and the degree of refinement. Oxidation may be inhibited by the inclusion of a suitable

510 Petrolatum

antioxidant such as butylated hydroxyanisole, butylated hydroxytoluene, or alpha tocopherol.

Petrolatum should not be heated for extended periods above the temperature necessary to achieve complete fluidity (approximately 708C). See also Section 18.

Petrolatum may be sterilized by dry heat. Although petrolatum may also be sterilized by gamma irradiation, this process affects the physical properties of the petrolatum such as swelling, discoloration, odor, and rheological behavior.(6,7)

Petrolatum should be stored in a well-closed container, protected from light, in a cool, dry place.

Incompatibilities

Petrolatum is an inert material with few incompatibilities.

Method of Manufacture

Petrolatum is manufactured from the semisolid residue that remains after the steam or vacuum distillation of petroleum.(8) This residue is dewaxed and/or blended with stock from other sources, along with lighter fractions, to give a product with the desired consistency. Final purification is performed by a combination of high-pressure hydrogenation or sulfuric acid treatment followed by filtration through adsorbents. A suitable antioxidant may be added.

Safety

Petrolatum is mainly used in topical pharmaceutical formula- tions and is generally considered to be a nonirritant and nontoxic material.

Animal studies, in mice, have shown petrolatum to be nontoxic and noncarcinogenic following administration of a single subcutaneous 100 mg dose. Similarly, no adverse effects were observed in a 2-year feeding study with rats fed a diet containing 5% of petrolatum blends.(9)

Although petrolatum is generally nonirritant in humans following topical application, rare instances of allergic hyper- sensitivity reactions have been reported,(10–12) as have cases of acne, in susceptible individuals following repeated use on facial skin.(13) However, given the widespread use of petrolatum in topical products, there are few reports of irritant reactions. The allergic components of petrolatum appear to be polycyclic aromatic hydrocarbons present as impurities. The quantities of these materials found in petrolatum vary depending upon the source and degree of refining. Hypersensitivity appears to occur less with white petrolatum and it is therefore the preferred material for use in cosmetics and pharmaceuticals.

Petrolatum has also been tentatively implicated in the formation of spherulosis of the upper respiratory tract following use of a petrolatum-based ointment packing after surgery,(14) and lipoid pneumonia following excessive use in the perinasal area.(15) Other adverse reactions to petrolatum include granulomas (paraffinomas) following injection into soft tissue.(16) Also, when taken orally, petrolatum acts as a mild laxative and may inhibit the absorption of lipids and lipid- soluble nutrients.

Petrolatum is widely used in direct and indirect food applications. In the USA, the daily dietary exposure to petrolatum is estimated to be 0.404 mg/kg body-weight.(17)

For further information see Mineral Oil and Paraffin.

Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. For recommended occupa- tional exposure limits see Mineral Oil and Paraffin.

Regulatory Status

GRAS listed. Accepted for use in certain food applications in many countries worldwide. Included in the FDA Inactive Ingredients Guide (ophthalmic preparations, oral capsules and tablets, otic, topical, and transdermal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.

Related Substances

Mineral oil; mineral oil light; paraffin; petrolatum and lanolin alcohols; white petrolatum.

White petrolatum

Synonyms: vaselinum album; white petroleum jelly; white soft paraffin.

Appearance: white petrolatum is a white to pale yellow- colored, translucent, soft unctuous mass. It is odorless and tasteless and not more than slightly fluorescent by daylight, even when melted.

Method of manufacture: white petrolatum is petrolatum that has been highly refined so that it is wholly or nearly decolorized.

Comments: white petrolatum is associated with fewer instances of hypersensitivity reactions and is the preferred petrolatum for use in cosmetics and pharmaceuticals, see Section 14.

Comments

Various grades of petrolatum are commercially available, which vary in their physical properties depending upon their source and refining process. Petrolatum obtained from different sources may therefore behave differently in a formulation.(18)

Care is required in heating petrolatum because of its large coefficient of thermal expansion. It has been shown by both rheological and spectrophotometric methods that petrolatum undergoes phase transition at temperatures between 30–408C. Additives, such as microcrystalline wax, may be used to add body to petrolatum. A specification for petrolatum is contained

in the Food Chemicals Codex (FCC).

The EINECS number for petrolatum is 232-373-2.

Specific References

Smack DP, Harrington AC, Dunn C, et al. Infection and allergy incidence in ambulatory surgery patients using white petrolatum vs bacitracin ointment: randomized controlled trial. JAMA 1996; 276: 972–977.

Boylan JC. Rheological estimation of the spreading characteristics of pharmaceutical semisolids. J Pharm Sci 1967; 56: 1164–1169.

Longworth AR, French JD. Quality control of white soft paraffin. J Pharm Pharmacol 1969; 21 (Suppl.): 1S–5S.

Barry BW, Grace AJ. Grade variation in the rheology of white soft paraffin BP. J Pharm Pharmacol 1970; 22 (Suppl.): 147S–156S.

Barry BW, Grace AJ. Structural, rheological and textural proper- ties of soft paraffins. J Texture Studies 1971; 2: 259–279.

Jacob BP, Leupin K. Sterilization of eye–nose ointments by gamma radiation [in German]. Pharm Acta Helv 1974; 49: 12–20.

Davis SS, Khanderia MS, Adams I, et al. Effect of gamma radiation on rheological properties of pharmaceutical semisolids. J Texture Studies 1977; 8: 61–80.

Petrolatum 511

Schindler H. Petrolatum for drugs and cosmetics. Drug Cosmet Ind 1961; 89(1): 36, 37, 76, 78–80, 82.

Oser BL, Oser M, Carson S, Sternberg SS. Toxicologic studies of petrolatum in mice and rats. Toxicol Appl Pharmacol 1965; 7: 382–401.

Dooms-Goossens A, Degreef H. Contact allergy to petrolatums I: sensitivity capacity of different brands of yellow and white petrolatums. Contact Dermatitis 1983; 9: 175–185.

Dooms-Goossens A, Degreef H. Contact allergy to petrolatums II: attempts to identify the nature of the allergens. Contact Dermatitis 1983; 9: 247–256.

Dooms-Goossens A, Dooms M. Contact allergy to petrolatums III: allergenicity prediction and pharmacopeial requirements. Contact Dermatitis 1983; 9: 352–359.

Verhagen AR. Pomade acne in black skin [letter]. Arch Dermatol

1974; 110: 465.

Rosai J. The nature of myospherulosis of the upper respiratory tract. Am J Clin Pathol 1978; 69: 475–481.

Cohen MA, Galbut B, Kerdel FA. Exogenous lipoid pneumonia caused by facial application of petrolatum. JAMA 2003; 49: 1128–

1130.

Crosbie RB, Kaufman HD. Self-inflicted oleogranuloma of breast.

Br Med J 1967; 3: 840–841.

Heimbach JT, Bodor AR, Douglass JS, et al. Dietary exposure to mineral hydrocarbons from food-use applications in the United States. Food Chem Toxicol 2002; 40: 555–571.

Kneczke M, Landersjo¨ L, Lundgren P, Fu¨ hrer C. In vitro release of salicylic acid from two different qualities of white petrolatum. Acta Pharm Suec 1986; 23: 193–204.

General References

Bandelin FJ, Sheth BB. Semisolid preparations. In: Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology, vol. 14. New York: Marcel Dekker, 1996: 31–61.

Barker G. New trends in formulating with mineral oil and petrolatum.

Cosmet Toilet 1977; 92(1): 43–46.

Davis SS. Viscoelastic properties of pharmaceutical semisolids I: ointment bases. J Pharm Sci 1969; 58: 412–418.

De Muynck C, Lalljie SPD, Sandra P, et al. Chemical and physico- chemical characterization of petrolatums used in eye ointment formulations. J Pharm Pharmacol 1993; 45: 500–503.

De Rudder D, Remon JP, Van Aerde P. Structural stability of ophthalmic ointments containing soft paraffin. Drug Dev Ind Pharm 1987; 13: 1799–1806.

Morrison DS. Petrolatum: a useful classic. Cosmet Toilet 1996; 111(1): 59–66, 69.

Smolinske SC. Handbook of Food, Drug, and Cosmetic Excipients.

Boca Raton, FL: CRC Press, 1992: 265–269.

Sucker H. Petrolatums: technological properties and quality assess- ment. Cosmet Perfum 1974; 89(2): 37–43.

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