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Monday, 27 July 2015 08:16

Technical Report: Evaluation of the Content Uniformity of 9 SuspendIt™ Formulations

One base suspends it all. SuspendIt's superior anti-sedimentation technology can deliver everything you need to compound oral suspensions - it's the all-in-one oral suspension base.

Introduction:

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Suspensions are pharmaceutical dosage forms consisting of insoluble active pharmaceutical ingredients (APIs) dispersed in a liquid medium (suspending vehicle). The type of suspension varies depending on the route of administration (e.g., oral, topical or injectable suspensions). Oral suspensions, being the most common, are advantageous in their ability to allow for easy swallowing of medication by pediatric and geriatric patients, in comparison to solid dosage forms.  However, due to the heterogeneous nature of suspensions, the insoluble APIs have a tendency to settle at the bottom of containers upon standing. 

For this reason, if patients forget to shake the suspensions or do not shake adequately prior to each dose administration, the content uniformity and dosing accuracy of the medications may be compromised [1]. Content uniformity is defined as the consistency in the amount of APIs among dosage units.  An ideal suspension should be uniform in content so that each dose is equivalent in the amount of APIs [2]. Content uniformity within a suspension is highly dependent on the characteristics of the suspending vehicle. If a suspending vehicle is too viscous, the APIs will not be easily dispersed. In contrast, if the suspending vehicle is too thin, the APIs will settle at the bottom of the container [1].

The purpose of this study was to evaluate the content uniformity of nine suspensions, each containing one API dispersed in SuspendIt.  SuspendIt is a proprietary suspending vehicle with a synergistic polymer complex (patent pending), which gives suspensions the ability to thin with agitation and thicken upon standing.  This characteristic is very important in suspensions as the polymer complex can enhance redispersion and minimize sedimentation of APIs [3]. (SOPs) indicated in the respective PCCA Formulas (Table 1). 

For each SuspendIt formulation, the total volume of 150 mL was divided in 30 unit dose oral syringes of 5 mL each; suspensions were shaken prior to the drawing of each unit dose. An example of oral syringes is displayed in Figure 1. In accordance with the United States Pharmacopeia (USP) General Chapter <905> “Uniformity of Dosage Units” [2], a random sample of 10 unit dose oral syringes was selected and tested individually for each SuspendIt formulation, using an appropriate analytical method for chemical characterization.

Abstract:

Suspensions are pharmaceutical dosage forms consisting of insoluble APIs dispersed in a vehicle. An ideal suspension should be uniform in content so that each dose is equivalent in the amount of APIs. The purpose of this study was to evaluate the content uniformity of nine suspensions, each containing one API dispersed in SuspendIt, a proprietary suspending vehicle with a synergistic polymer complex (patent pending), which gives suspensions the ability to thin with agitation and thicken upon standing. This study has demonstrated that all nine SuspendIt formulations were uniform in content. By following the SOPs set forth in the PCCA formulas, compounding pharmacists are thus likely to meet the requirements of content uniformity and, as a result, dispense unit dose oral syringes in accordance to the label claim.

Conclusions:

It is the pharmacists’ responsibility to ensure that compounded medicines are dispensed in accordance to the label claim [5]. For unit dose preparations, the content of uniformity must be ensured so that all individual units meet the label claim. The content of uniformity is particularly important when dispensing unit dose oral suspensions as, depending on the characteristics of the suspending vehicle, APIs may not be evenly dispersed or may settle at the bottom of the container, resulting in oral syringes of variable concentrations [4]. The Food and Drug Administration (FDA) requires that SOPs are followed in the preparation of oral suspensions to ensure the quality and safety of compounded medicines. Therefore, the FDA may warrant testing of oral suspensions to ensure that segregation has not occurred and that the content of each unit dose is uniform [6]. This study has demonstrated that all nine SuspendIt formulations were uniform in content. By following the SOPs set forth in the PCCA formulas (Table 1), compounding pharmacists are thus likely to meet the requirements of content uniformity and, as a result, dispense unit dose oral syringes in accordance to the label claim.

Download the complete PDF detailing the results of this study.

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