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by Maria Carvalho, PharmD, MRPharmS, PhD, PCCA Manager of PCCA Science
Suspensions are pharmaceutical dosage forms consisting of insoluble active ingredients dispersed in a base vehicle. An ideal suspension should be uniform in content so each dose contains an equivalent amount of one or more — most likely one — active pharmaceutical ingredients (APIs). We briefly review oral suspensions and why content uniformity is vital in compounded preparations, as well as showcase the most studied oral suspension, in the following article.
The type of suspension used to compound preparations depends on the route of administration: oral, topical or injectable. Oral liquid suspensions are advantageous in their ability to provide an easy-to-swallow medication for pediatric, geriatric and patients challenged by other dosage forms such as tablets and capsules. However, due to the heterogeneous nature of liquid suspensions, insoluble APIs tend to settle at the bottom of containers when standing. For this reason, if patients or caregivers forget to agitate — or shake — the preparation or do not agitate it adequately before administration, the content uniformity and dosing accuracy of the APIs may be compromised.
Content uniformity, defined as the consistency in the amount of APIs among dosage units, is determined by performing a series of tests using APIs and the suspension vehicle. An ideal suspension should retain content uniformity so that each dose contains an equivalent amount of APIs. As such, content uniformity is highly dependent on the characteristics of the suspension. If a suspending vehicle is too viscous — or has a thick and sticky consistency — APIs are not easily dispersed. In contrast, if the suspending vehicle is too thin, the APIs will settle at the bottom of the container.1
PCCA SuspendIt® (PCCA #30-4825) is our “all-in-one” aqueous (water activity [aw] > 0.6) oral suspension vehicle. It contains a synergistic polymer complex that offers a unique thixotropic flow — which means it thins when shaken and thickens upon standing — that allows rapid redispersion of APIs and minimizes sedimentation. Made with an all-natural sweetener derived from monk fruit, SuspendIt is an ideal choice for patients requiring formulations without sugar, casein or gluten.
As an aqueous oral suspension, SuspendIt uses potassium sorbate and sodium benzoate as preservatives. The November 2023 revisions to the United States Pharmacopeia (USP) 795 offer beyond-use dates (BUDs) of up to 35 days for an aqueous, preserved preparation.
Although SuspendIt may be used in veterinary preparations, it’s important to recognize that in felines, sodium benzoate can be a potential toxin when chronically administered and use should be limited to two weeks.
SuspendIt is featured in all USP monographs and is currently one of the most studied oral vehicles in the compounding industry. SuspendIt studies, including scientific journal abstracts, scientific posters and a technical report summarizing the content uniformity of eight SuspendIt formulations, are available in SuspendIt Scientific Publications.
Within one minute, this timelapse video shows the content uniformity between SuspendIt and a competitor’s suspension base over the course of five days.
PCCA members with clinical services access may view and/or download PCCA SuspendIt formulations — including formulas with FormulaPlus™ BUD Studies — after logging on to our Members-Only Website. Clinical services access also allows members to contact our Clinical Services team for additional information on compounding SuspendIt preparations and other compounding concerns. Members without clinical services access can learn how to connect with the experts on our Clinical Services team HERE.
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These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.