TABLE 10 REFERENCES VOLUME 14 NUMBER 1 STABILITY OF ...

1 secundum REFERENCES VOLUME 14 NUMBER 1. It is commercially available only as a compressed tablet. TABLE 8 TABLE 10. The authors used the tablets to prepare suspensions with 1:1 mixtures of Ora-Sweet/Ora-Plus or Ora-Sweet SF/Ora- STABILITY OF NIFEDIPINE 4 MG/ML SUSPENSIONS STABILITY OF SILDENAFIL CITRATE MG/ML SUS- AT TWO TEMPERATURES 1. Justice J, Kupiec TC, Matthews P, Cardona P. Sta- Plus at nominal concentrations of 1 mg/mL. The PENSIONS AT TWO TEMPERATURES. % Initial Concentration Remaining bility of Adderall in extemporaneously com preparations were stored at both room and refrigerated Percent of initial concentration remaining pounded oral liquids. Am J Health-Syst Pharm. Artem temperatures. The results showed the lamotrigine suspen- Ora-Sweet/Ora-Plus 1% Methylcellulose/Syrup Ora-Sweet/Ora-Plus 1% Methylcellulose/Syrup Day 25 C 4 C 25 C 4 C 2001; 58:1418-21.

2 Sions to be stable throughout the 91 day study period at Day 4 C 25 C 4 C 25 C. 2. Pharmacopeia 29-National Formulary 24. both temperatures. The initial pH values were and 0 (mg/mL) Rockville MD. Pharmacopeial Convention, for the Ora-Sweet/Ora-Plus and Ora-Sweet SF/Ora-Plus, 0 (mg/mL) 7 Inc., 2005, pp 986-7, 3193, 3194, 3202, 3208, 3225. ,8 7 14 3. Nahata MC, Rosoco RS, Hipple TF. STABILITY of 14 28 amiodarone in extemporaneous oral suspensions TABLE 7 28 42 prepared from commercially available vehicles. 42 56 J Ped Phar Prac. Jul/Aug, 1999; 4(4):186-189. STABILITY OF LAMOTRIGINE 1 MG/ML 56 SUSPENSION AT TWO TEMPERATURES 70 70 4. Nahata MC, Morosco RS, Hipple TF. STABILITY of Current & Practical Compounding 91 amlodipine besylate in two liquid dosage forms. Information for the Pharmacist. SUMMARY. % Initial Concentration Remaining 91 J Am Pharm Assoc.

3 1999;39(3):375-7. 4 C 25 C 5. Garner SS, Wiest DB, Reynolds Jr ER. STABILITY of An ongoing CE Program provided by a grant Ora-Sweet Ora-Sweet SF Ora-SweetOra-Sweet SF Propylthiouracil from Paddock Laboratories, Inc. In summary, it appears that Adderall (1 mg/mL in Ora- atenolol in an extemporaneously compounded STABILITY OF EXTEMPORANEOUSLY PREPARED. Day /Ora-Plus /Ora-Plus /Ora-Plus /Ora-Plus Propylthiouracil is used in the treatment of hyperthy- Sweet/Ora-Plus) is stable for at least 30 days at 25 C; oral liquid. Am J Hosp Pharm. 1994;51:508-11. ORAL LIQUID FORMULATIONS - PART IV. roidism in pediatric patients. It is available as a 50 mg amiodarone (5 mg/mL in Ora-Sweet/Ora-Plus and 6. Nahata MC, Morosco RS, Trowbridge JM. Stabili- 0 (mg/mL) tablet but not in an oral liquid dosage form. Propylth- Ora-Sweet SF/Ora-Plus) is stable for 42 days at 25 C ty of dapsone in two oral liquid dosage forms.

4 7 iouracil occurs as a white, powdery, crystalline and 91 days at 4 C; amlodipine besylate (1 mg/mL in Ann Pharmacother 2000;34:848-50. 14 GOALS AND OBJECTIVES. substance with an appearance and touch similar to Ora-Sweet/Ora-Plus and 1% methylcellulose/simple 7. Anaizi NH, Swenson CF, Dentinger PJ. STABILITY of 28 starch and it has a bitter taste. It is slightly soluble in syrup) is stable for 56 days at 25 C and 91 days at 4 C; ganciclovir in extemporaneously compounded Goal: To provide information from the peer-reviewed literature on STABILITY studies of extemporaneously prepared 42 atenolol 2 mg/mL in Ora-Sweet SF only for 90 days at oral liquids. Am J Health-Syst Pharm. 56 water and sparingly soluble in alcohol. 1999;56:1738-41. oral liquids. 25 C and in Roxane Diluent for 40 days at 25 C; dap- 70 This study utilized the 50 mg commercial tablets to sone (2 mg/mL in Ora-Sweet/Ora-Plus and 2% citric 8.)

5 Nahata MC, Morosco RS, Hipple TF. STABILITY of 91 prepare suspensions with a 1:1 mixture of Ora- acid solution/syrup 1:3) for 91 days at both room lamotrigine in two extemporaneously prepared Objectives: After reading and studying the article, the reader will be able to: Sweet/Ora-Plus or 1% methylcellulose/simple syrup 25 and refrigerated 4 temperatures; ganciclovir (100 oral suspensions at 4 and 25 C. Am J Health-syst 1. discuss the legislative and regulatory activities involving medications for pediatric patients. Nifedipine at a concentration of 5 mg/mL. The suspensions were mg/mL in Ora-Sweet only or Ora-Sweet SF only) for Pharm. 1999;56:240-2. stored at both room and refrigerated temperatures. 123 days at 25 C; lamotrigine (1 mg/mL in Ora- 9. Nahata MC, Morosco RS, Willhite EA. STABILITY of 2. describe the general study designs for STABILITY studies used to aid in establishing beyond-use dates.

6 Nifedipine is used in the treatment of hypertension in The results of the study showed that both vehicle for- Sweet/Ora-Plus and Ora-Sweet SF/Ora-Plus) was nifedipine in two oral suspensions stored at two 3. discuss the care to be used in terminology related to assigning beyond-use dates. pediatric patients. It is available as sustained-release mulations stored at room temperature were stable for stable for 91 days at both room and refrigerated tem- temperatures. J Am Pharm Assoc. 2002;42(6):865-867. 4. observe the presented tabular data and determine a reasonable beyond-use date for the presented drugs. tablets and liquid-filled capsules. Consequently, a liq- 70 days and those stored at refrigerated temperature peratures; nifedipine (4 mg/mL in Ora-Sweet/Ora-Plus 10. Nahata MC, Morosco RS, Trowbridge JM. Stabili- uid dosage form is needed for pediatric patients.

7 Were stable for 91 days 2,10 and 1% methylcellulose/simple syrup) for 3 months at ty of propylthiouracil in extemporaneously pre- INTRODUCTION. Nifedipine occurs as a yellow powder that is affected both room and refrigerated temperatures; propylth- pared oral suspensions at 4 and 25 C. Am J. upon exposure to light. It is practically insoluble in TABLE 9 iouracil (5 mg/mL in Ora-Sweet/Ora-Plus and 1% Health-Syst Pharm. 2000;57:1141-3. that commonly arises relates to the STABILITY of the active ingre- water. methylcellulose/simple syrup) for 70 days at 25 and 91 11. Nahata MC, Morosco RS, Brady MT. Extempora- dient in the selected vehicle. This is Part IV in a series designed STABILITY OF PROPYLTHIOURACIL 5 MG/ML SUS- On January 4, 2002, the President signed into law , the to summarize STABILITY studies that have been conducted in dif- PENSIONS AT TWO TEMPERATURES days at 4 C.

8 ; and sildenafil ( mg/mL in Ora- neous sildenafil citrate oral suspensions for the In this study, the capsules were used to prepare the Sweet/Ora-Plus and 1% methylcellulose/syrup) for 91 treatment of pulmonary hypertension in children. Best Pharmaceuticals for Children Act, as 107-109. This ferent vehicles, including either Ora-Sweet , Ora-Sweet . % Initial concentration Remaining legislation actually reauthorizes the pediatric studies provision SF, Ora-Plus , or their combinations; and methylcellulose suspensions at a concentration of 4 mg/mL using Ora-Sweet/Ora-Plus 1% Methylcellulose/Syrup days at both temperatures. Am J Health-Syst Pharm. 2006;63:254-257. vehicles of 1:1 Ora-Sweet/Ora-Plus and 1% methyl- of the Food and Drug Administration Modernization Act of and syrup combinations. Day 4 C 25 C 4 C 25 C. STUDY DESIGNS.

9 Cellulose/simple syrup. The capsules were emptied 1997 (FDAMA97). It encourages pharmaceutical companies, by of about 95% of the nifedipine using the following 0 (mg/mL) extending their market exclusivity, to conduct pediatric stud- procedure. The top of the capsule was punctured 7 ies of new and already marketed drugs used in pediatric PRSRT STD. populations but are not labeled for such use. Most STABILITY studies result from questions involving commonly with one needle to create a vent. Another needle 14 POSTAGE. used dosages in children. It is routine to study only one, or maybe PAID. attached to a syringe was used by inserting it through 28 Minneapolis, MN. This new legislation provides several avenues by which drugs two, concentrations of a drug in the selected vehicles. Tempera- the bottom of the capsule and extracting the liquid by 42 already on the market can be tested in children.

10 These involve tures commonly used in these studies include room temperature Permit No. 1700. pulling back on the plunger of the syringe. The nee- 56 (1) the patent holder doing the testing and gaining an addi- and/or refrigerated temperature. The preparations are generally dle bevel was positioned close to the edge of the 70 tional six months exclusivity, (2) if off patent and placed in light-resistant containers and sampled at pre-deter- capsule and when a bubble first appeared in the 91 manufacturers reject a request from the FDA to test it in chil- mined intervals. The preparations may be prepared from either syringe, the operator paused for about 5 seconds, dren, the Secretary of HHS may ask the NIH to undertake the commercial dosage forms or from USP-grade substances. Sildenafil then continued withdrawing the plunger.