By Maria Carvalho, PharmD, MRPharmS, PhD, Manager of PCCA Science

Compounding pharmacists often need to prepare palatable, uniform, stable oral liquids, particularly for pediatric patients. Issues with taste-masking; solubility; and physical, chemical and microbiological stability must be considered when preparing these customized oral liquid medications. In order to ensure optimal formulations and enhanced compliance for each unique patient, PCCA developed SuspendIt , a contemporary suspending vehicle that offers convenience and dosing flexibility for compounded medications. SuspendIt has special thixotropic properties that allow it to thicken when standing in order to minimize the settling of particles and become thinner when shaken so the medication can be accurately administered. It is also sugar-free, paraben-free, dye-free and gluten-free.

PCCA members with Clinical Services have access to over 150 standardized formulas for SuspendIt oral liquids, many with beyond-use-dates (BUDs) superior to those pre-established by the United States Pharmacopeia (USP). Stability testing is particularly important for oral liquids, but this is a costly and time-consuming process that requires physical, chemical and microbiological expertise. For this reason, PCCA partnered with the College of Pharmacy at Xavier University of Louisiana (XULA) for the development of academic, peer-reviewed stability studies on SuspendIt. Supported by governmental grants from the National Institutes of Health and the U.S. Department of Health and Human Services, and financial sponsorship from PCCA, researchers at XULA have already published a total of eight validated stability studies in the International Journal of Pharmaceutical Compounding (IJPC). The initial studies evaluated the physical and chemical stability of a SuspendIt formula for a standard drug concentration (e.g., clindamycin hydrochloride 10 mg/mL) at three temperature conditions (5° C, 25° C and 40° C). The later studies evaluated the stability of a bracketed drug concentration (e.g., ursodiol 50–100 mg/mL) at two temperature conditions (5° C and 25° C). These allow compounders to use a single formula to create a number of compounds with extended BUDs as long as the active ingredient in each compound is within the range of strengths listed in the formula. IJPC recognized the quality of these academic studies by adopting some of the SuspendIt formulas as official IJPC formulas.

Learn more about our standardized oral liquid formulations here on The PCCA Blog: “ The Importance of Standardized Formulations for Patient Safety .”

The high quality of these studies has been recognized further by USP, which adopted three of these academic studies as official monographs: “Clindamycin Hydrochloride Compounded Oral Solution,” official as of August 1, 2019, as well as the spironolactone and ursodiol studies, which are not yet official. Furthermore, USP gave its Silver Award in 2018 and Golden Award in 2019 to Dr. Yashoda Pramar, the lead researcher for these studies at XULA. These awards recognize the contribution of new monographs as part of USP’s Donor Recognition Program. Academic institutions like XULA are recognized for their unbiased, state-of-the-art research, and PCCA is very proud of this ongoing partnership.

Below are brief summaries of the published, peer-reviewed stability studies of compounded medications with SuspendIt that researchers at the XULA College of Pharmacy have conducted.

1. “Stability of Clindamycin Hydrochloride in PCCA Base SuspendIt” 

This study was initially published in the September/October 2016 issue of IJPC , and the formula was subsequently recognized as an official formula in the January/February 2017 issue of IJPC . The formula was also adopted as an official USP Compounded Preparation Monograph, “Clindamycin Hydrochloride Compounded Oral Solution,” on August 1, 2019. It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded clindamycin hydrochloride 10 mg/mL oral suspension in SuspendIt.

2. “Stability of Spironolactone Oral Suspension in PCCA Base, SuspendIt”

This study was initially published in the July/August 2017 issue of IJPC , and the formula was subsequently recognized as an official formula in the November/December 2017 issue of IJPC and the March/April 2018 issue of IJPC . The formula has also been accepted as a USP Compounded Preparation Monograph, but it is not official yet. It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded spironolactone 5 mg/mL oral suspension in Suspendit.

3. “Physicochemical Stability of an Oral Suspension of Trimethoprim 20 mg/mL in Combination with Sulfadiazine 200 mg/mL in PCCA Base, SuspendIt”

This study was initially published in the September/October 2017 issue of IJPC , and the formula was subsequently recognized as an official formula in the May/June 2018 issue of IJPC . It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded trimethoprim 20 mg/mL and sulfadiazine 200 mg/mL oral suspension in SuspendIt.

4. “Stability of Compounded Ursodiol Suspensions in PCCA Base, SuspendIt”

This study was published in the January/February 2019 issue of IJPC . The formula has also been accepted as a USP Compounded Preparation Monograph, but it is not official yet. It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded ursodiol 50–100 mg/mL oral suspensions in SuspendIt.

This stability study was also presented by lead XULA researcher Dr. Yashoda Pramar at the 2018 APhA (American Pharmacists Association) Annual Meeting & Exposition in Nashville, Tennessee, as a poster presentation (Figure 1).

Figure 1. Scientific poster presented by XULA researchers at the 2018 APhA Annual Meeting & Exposition.

5. “Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base, SuspendIt”

This study was published in the March/April 2019 issue of IJPC . It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded naltrexone hydrochloride 0.5–5 mg/mL oral solutions in SuspendIt.

This stability study was also presented by lead XULA researcher Dr. Yashoda Pramar at the 2019 APhA Annual Meeting & Exposition in Seattle, Washington, as an oral presentation.

6. “Physicochemical Stability of Compounded Amlodipine Besylate Suspensions in PCCA Base, SuspendIt ”

This study was published in the November/December 2019 issue of IJPC . It establishes BUDs of 90 days at refrigerated temperature and 7 days at room temperature for the studied formulation of compounded amlodipine besylate 0.5–10 mg/mL oral suspensions in SuspendIt.

7. “Physicochemical Stability of Compounded Allopurinol Suspensions in PCCA Base, SuspendIt”

This study was published in the September/October 2020 issue of IJPC . It establishes a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded allopurinol 10–20 mg/mL oral suspensions in SuspendIt.

8. “Physicochemical and Microbiological Stability of Compounded Metronidazole Suspensions in PCCA Base, SuspendIt”

This study will be published in a future issue of IJPC. It will establish a BUD of 180 days at refrigerated and room temperatures for the studied formulation of compounded metronidazole 25–50 mg/mL oral suspensions in SuspendIt.

PCCA members with Clinical Services access can find PCCA compounded oral suspension formulas that correspond to the ones above in our formula database.
 

Maria Carvalho, PharmD, MRPharmS, PhD, is the Manager of PCCA Science. She is a certified pharmacist in Portugal and the United Kingdom with a PhD in pharmaceutical compounding from the University College of London (UCL). Maria has worked in community pharmacy, hospital pharmacy and the pharmaceutical industry in Europe and the United States. She was a teaching assistant at the UCL School of Pharmacy (UK) and an invited teacher at the University Fernando Pessoa (Portugal). Maria has authored and co-authored many scientific publications, including the book: Compounding Practices in Europe (ISBN-10:149236925X).