FORMULA NUMBER: 2326

FORMULA NAME: Acyclovir 43−mg/mL Oral Suspension, Preserved

DOSAGE FORM: Suspension

FORMULA (Rx):

Ingredients For: 100 mL Lot# RPh Initials

Acyclovir 4 .3 g _________________________ __________
Sorbitol Solution 70% Aqueous 45 g _________________________ __________
Methylparaben 100 mg _________________________ __________
Propylparaben 20 mg _________________________ __________
Cellulose, Microcrystalline [Avicel RC−591] 1 .5 g _________________________ __________
Glycerin 15 g _________________________ __________
Flavor qs* _________________________ __________
Water, Purified USP qs 100 mL _________________________ __________

SYNONYMS:
Acyclovir 215−mg/5mL Suspension; Zovirax; Aciclovir

USE/TYPE: CATEGORY:
Human Use AntiViral
Non−Sterile Preparation

NOTES:
*Orange−banana dry flavor is suggested for the preparation. This preparation should be prepared in a vertical airflow hood in a
biological safety cabinet or barrier isolation technology. See also: Formulas No. 2333 and 2334.

SPECIALIZED EQUIPMENT:

Homogenizer Vortex or Magnetic Stirrer

METHOD OF PREPARATION:

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Accurately weigh and/or measure each ingredient.

3. Disperse acyclovir in the sorbitol 70% solution and stir continuously for one hour.

4. Heat 30−mL purified water in a beaker to 90° to 95°C and dissolve the methylparaben and propylparaben mixing until
solution is clear; cool to 30°C.

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Formula # 2326 − Page 2

5. Disperse the microcrystalline cellulose and glycerin in a beaker and conintue stirring for 1 hour.

6. Add the microcrystalline cellulose−glycerin mixture to the paraben solution at 30°C and mix for 5 minutes at high speed.

7. Add the acyclovir and sorbitol mixture to the suspension in step 6 for 5 minutes.

8. Disperse the flavor in 1−mL purified water and add to the suspension while stirring.

9. Bring to volume with purified water and homogenize for 5 minutes at high speed.

10. Package and label. Shake well.

LABELING:

For Oral Use Only Keep Out of Reach of Children

Shake Well

PRESERVATION, PACKAGING AND STORAGE:

Tight, Light Resistant Container Store at Room Temperature Away from Excessive Heat
Do Not Use After ___________________

STABILITY:
A beyond−use date of 14 days can be used for this preparation.

ENDOTOXIN ASSESSMENT:

USE:
For treatment of herpes simplex infections when an oral suspension is required for the patient. A calibrated dose−delivery device
is required with instructions to the caregiver or patient.

STANDARD OPERATING PROCEDURE FOR QUALITY CONTROL:

Assessments include weight and volume, pH, specific gravity, active drug assay, color, clarity, rheological properties such as
pourability, physical observation and physical stability such as discoloration, foreign materials, gas formation and mold growth.

REGULATORY CONTROL:

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Formula # 2326 − Page 3

REFERENCES:

1. United States Pharmacopeia. United States Pharmacopeia 32−National Formulary 27. Chapter <795> United States
Pharmacopeial Convention, Rockville MD; 2009.
2. Allen Loyd V Jr. Standard Operating Procedure for Quality Assessment of Oral and Topical Liquids. International Journal of
Pharmaceutical Compounding. 3(2); 1999:146.
3. Ashworth Lisa D. Quality Control: Standard Operating Procedures−−An Essential Tool for Developing Quality Preparations.
International Journal of Pharmaceutical Compounding. 11(3); 2007:226.
4. Fuller MA, Sajatovic M. Drug Information Handbook for Psychiatry. 7th Ed. Lexi−Comp Inc, Hudson OH; 2009:49−50.
5. Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations. Volume 3−Liquid Products. CRC Press, Boca Raton FL;
2004:68.
6. Tod M, Lokiec F, Bidault R, et. al. Pharmacokinetics of oral acyclovir in neonates and in infants: A population analysis.
Antimicrobial Agents and Chemotherapy. 45(1); 2001:150−157.
7. Henkin CC, Griener JC, Ten Eick AP. Stability of valganciclovir in extemporaneously compounded liquid formulations.
American Journal of Health−System Pharmacy. 60(7); 2003:687−690.
8. Kimberlin DW, Jacobs RF, Weller S, et. al. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral
suspension in pediatric patients from 1 month through 11 years of age. Clinical Infectious Diseases. 50(2); 2010:221−228.
9. Amir J. Clinical aspects and antiviral therapy in primary herpetic gingivostomatitis. Paediatric Drugs. 3(8); 2001:593−597.
10. Wiedermann BL, Amir J. Two commentaries on Acyclovir for treating primary herpetic gingivostomatitis. Evidence−Based
Child Health: A Cochrane Review Journal. 4(3); 2009:1244−1246.
11. Allen Loyd V Jr. Acyclovir 200−mg/5−mL Oral Suspension (From the Injection). International Journal of Pharmaceutical
Compounding. 14(2); 2010:151.

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