F O R M U L A T I O N S
`
`Lisinopril 1-mg/mL, Sodium Citrate, and Citric Acid Oral Liquid
`
`Purified water is water that is obtained by distillation, ion exchange,
`reverse osmosis, or some other suitable process. Water is used to de-
`scribe potable water from a public water supply that is suitable for
`drinking and is the beginning point of the official waters. It is a clear,
`colorless, odorless, and tasteless liquid. Water has a specific gravity
`of 0.9971 at room temperature, a melting point of 0°C, and a boiling
`point of 100°C. It is miscible with most polar solvents and is chemi-
`cally stable in all physical states (ice, liquid, steam).6
`Bicitra is a stable and pleasant-tasting grape-flavored citrate oral
`systemic alkalizer. It contains sodium citrate and citric acid in a
`sugar-free vehicle. It contains, in each 5 mL, sodium citrate dihy-
`drate 500 mg (0.34 M) and citric acid monohydrate 334 mg (0.32 M).
`It also contains butylparaben, flavoring, maltitol, and sodium sac-
`charin.7
`Ora-Sweet SF syrup is a flavoring vehicle for oral extemporaneous
`preparations. It is a sugar-free, alcohol-free syrup flavored with a
`citrus-berry flavor blend. It is buffered to a pH of approximately
`4.2 and may be used alone or in combination with other vehicles. It
`will tolerate dilution to 50% with dissolved actives in water or sus-
`pending agents and still retain an acceptable taste. It has an osmolal-
`ity of 2,150 mOsm/kg. It contains water, sodium saccharin, xanthan
`gum, glycerin, and sorbitol; citric acid and sodium citrate as buffers;
`methylparaben, propylparaben, and potassium sorbate as preserva-
`tives; and flavoring agents.8
`REFERENCES
`1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Pharmaco-
`peia.Rockville, MD: US Pharmacopeial Convention, Inc.; 2005: 408–413, 693.
`2. Thompson KC, Zhao Z, Mazakas M et al. Characterization of an extempora-
`neous liquid formulation of lisinopril. Am J Health Syst Pharm2003; 60(1):
`69–74.
`3. Allen LV Jr. Standard operating procedure for quality assessment of oral and
`topical liquids. IJPC1999; 3(2): 146–147.
`4. McEvoy GK, ed. AHFS Drug Information–2006.Bethesda, MD: American So-
`ciety of Health-System Pharmacists; 2006: 1924–1928.
`[No author listed.] Physicians’ Desk Reference.60th ed. Montvale, NJ: Thomson
`PDR; 2006: 704–709, 2029–2033.
`6. Galichet LY. Water. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook of
`Pharmaceutical Excipients.5th ed. Washington, DC: American Pharmaceu-
`tical Association; 2006: 802–806.
`[No author listed.] Physicians’ Desk Reference.54th ed. Montvale, NJ: Thomson
`PDR; 2000: 506–507.
`8. Ora-Sweet SF [product information]. Minneapolis, MN: Paddock Laboratories,
`Inc.
`
`5.
`
`7.
`
`Rx
`
`For 100 mL
`Lisinopril
`Purified water
`Bicitra
`Ora-Sweet SF qs
`
`100 mg
`5 mL
`15 mL
`100 mL
`
`METHOD OF PREPARATION
`1. Calculate the required quantity of each ingredient for the total
`amount to be prepared.
`2. Weigh and/or measure each ingredient accurately.
`3. Pulverize the lisinopril tablets to a fine powder.
`4. Add the purified water to the powder and mix well.
`5. Add the Bicitra and mix well.
`6. Add the Ora-Sweet SF to volume and mix well.
`7. Package and label.
`PACKAGING
`Package in tight, light-resistant containers.1
`LABELING
`Keep out of reach of children. Use only as directed.
`STABILITY
`A beyond-use date of 6 weeks is appropriate for this preparation.1,2
`USE
`Lisinopril with sodium citrate and citric acid oral solution has been
`used for the treatment of hypertension, heart failure, and acute myo-
`cardial infarction.2
`QUALITY CONTROL
`Quality-control assessment can include weight/volume, pH, specific
`gravity, active drug assay, color, clarity, rheological properties/pour-
`ability, physical observation, and physical stability (discoloration,
`foreign materials, gas formation, mold growth).3
`DISCUSSION
`Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor used
`alone or in combination with other classes of antihypertensive agents
`in the management of mild to severe hypertension. It is also listed
`as useful in congestive heart failure, acute myocardial infarction, and
`diabetic nephropathy.4
`Lisinopril (C21H31N3O5.2H2O, MW 441.52, Prinivil, Zestril) occurs
`as a white, crystalline powder that is soluble in water and practically
`insoluble in alcohol. It melts at about 160°C. The 5-, 10-, 20-, and
`40-mg Prinivil tablets also contain calcium phosphate, mannitol,
`magnesium stearate, and starch. The 10-, 20-, and 40-mg tablets also
`contain iron oxide. The 2.5-, 5-, 10-, 20-, 30-, and 40-mg Zestril
`tablets also contain calcium phosphate, mannitol, magnesium stea-
`rate, and starch. The tablets differ in the coloring agent used; the
`2.5-mg tablets contain no coloring agent; the 5-, 10-, 20-, and 30-mg
`tablets contain red ferric oxide; and the 40-mg tablets contain yellow
`ferric oxide.5
`
`386 International Journal of Pharmaceutical Compounding
`Vol. 10 No. 5 September/October 2006
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`Flat Line Capital Exhibit 1010
`Page 1 of 1
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`KVK-Tech, Flat Line Capital Exhibit 1010
`Page 1
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