THE PCCA BLOG

Similar Names. Different Products - SuspendIt® & SuspendIt® Anhydrous

Wed, 05 Apr 2023 11:00:00 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Although SuspendIt® and SuspendIt® Anhydrous share similar names and some characteristics, the two oral suspending vehicles are very different. Each product offers distinct benefits to compounders and patients. Most notably, SuspendIt is an aqueous (containing water) base and SuspendIt Anhydrous is a nonaqueous (anhydrous) base.

Water Activity

In the revisions to USP 795, effective November 1, 2023, a distinction is made between aqueous and nonaqueous preparations based on their water activity (a_w).

Water activity is not a measure of water content, but rather the water in a substance that is unbound and freely available to participate in reactions such as hydrolysis that may cause drug degradation or in the proliferation of microbes, causing microbial growth or contamination. A water activity equal to or greater than 0.6 defines a preparation as aqueous, while a water activity below 0.6 defines a nonaqueous preparation. Compounders are not expected to test for water activity, but rather to consider the dosage form they are making against a lengthy table in the revisions to 795.

Aqueous preparations are offered shorter BUDs compared to nonaqueous preparations unless the appropriate data exists to support longer BUDs. PCCA has created a number of formulations with this stability data and designates these as FormulaPlus^TM formulations.

SuspendIt

SuspendIt (PCCA #30-4825) is our “all in one” aqueous (a_w > 0.6) oral suspension vehicle. SuspendIt contains a unique synergistic polymer complex, which allows rapid redispersion of APIs with agitation and minimizes sedimentation. It is made with an all-natural sweetener derived from monk fruit, making SuspendIt an ideal choice for patients requiring formulations without sugar, casein, gluten or any condition that requires an oral suspension formula. SuspendIt is compatible with all feeding tubes.

SuspendIt is a preserved aqueous oral suspension vehicle that uses sodium benzoate as the preservative. The revisions to USP 795 offers BUDs of up to 35 days for an aqueous preserved preparation. Please note that in felines, sodium benzoate can be a potential toxin when chronically administered and use should be limited to two weeks.

PCCA has created many formulations for SuspendIt including FormulaPlus^TMformulations supported by a stability indicating assay and USP 51 antimicrobial effectiveness testing.

SuspendIt Anhydrous

SuspendIt Anhydrous (PCCA #30-5176) is our patent-pending anhydrous oral suspension vehicle. As an anhydrous vehicle, its water activity is less than 0.6, which meets the definition of nonaqueous in the revisions to USP 795. The revised 795 provides up to a 90-day BUD for nonaqueous oral preparations.

We combined surfactants within our anhydrous vehicle to make SuspendIt Anhydrous water miscible. The self-emulsifying properties of SuspendIt Anhydrous may also improve the solubility, dispersibility and possibly enhance bioavailability of APIs with poor water-solubility.

SuspendIt Anhydrous is compatible with hydrophilic or lipophilic drugs. Naturally sweetened with monk fruit, it offers improved palatability and mixes easily with water, juice or breast milk. Its ability to mix with fluids may make patient compliance to medication adherence easier.

SuspendIt Anhydrous is also compatible with polyurethane nasogastric (feeding) tubes. It is preservative free and free of many allergens.

For veterinary compounding, please note that in animals with pancreatitis, the use of any anhydrous vehicle that contains a high concentration of oils is not recommended. Caution must also be exercised in certain species, such as birds or herbivorous animals.

Access to SuspendIt (aqueous) and SuspendIt Anhydrous provides opportunities for compounders to serve the needs of their patients as is appropriate between aqueous and nonaqueous preparations and BUDs that work for prescribers, patients and compounding pharmacists.

We are happy discuss these innovative bases with you and the value of PCCA Membership. Members with clinical services can call our Clinical Services team at 800.331.2498 to discuss use of these and other PCCA bases, or any additional compounding concerns.

At-a-Glance Reference

SuspendIt	SuspendIt Anhydrous
Part #30-4825	Part #30-5176
Aqueous – water activity > 0.6	Nonaqueous (anhydrous) – water activity
USP default BUD: 35 days	USP default BUD: 90 days

Backed by Science - SuspendIt® Anhydrous

Wed, 22 Mar 2023 12:23:07 GMT

by Maria Carvalho, PharmD, MRPharmS, PhD, Manager of PCCA Science (R&D) and Yi Liu, PharmD, PhD, RPh, PCCA Research Pharmacist

Our new, patent-pending base — SuspendIt Anhydrous — is an innovative anhydrous suspension vehicle that offers improved physical characteristics, broader application and the potential for longer default beyond use dates (BUDs). It is ideal for active pharmaceutical ingredients (APIs) that are unstable in water or have incompatibilities with existing aqueous vehicles.

We performed multiple tests, including evaluation of SuspendIt Anhydrous’ sedimentation properties, its self-emulsifying drug delivery system and compatibility with nasogastric feeling tubes, as summarized below.

Improved Physical Characteristics

A unique physical characteristic of SuspendIt Anhydrous is its improved viscosity, which reduces when shaken and thickens when standing. The improved viscosity allows for rapid redispersion of APIs with agitation and minimizes sedimentation. Sedimentation is the simple process in which suspended particles separate from a liquid and, due to gravity, settle on the bottom of a container.

In one of three studies, we evaluated and compared the sedimentation properties of SuspendIt Anhydrous to the performance of two competitor products (Product A and Product B) using an enrofloxacin 100 mg/mL anhydrous suspension (raspberry flavor, pink color). The suspensions were placed in a standing position at room temperature for 30 days. On day 28, the glass containers were shaken vigorously with the same amount of force and duration and allowed to settle again. By day 29 (after redispersion on day 28), SuspendIt Anhydrous remained a homogenous suspension with no signs of separation (Figures 1 – 3).

Self-Emulsifying Drug Delivery System

What makes our new base particularly unique is its self-emulsifying drug delivery system (SEDDS). The system creates a spontaneous emulsion when SuspendIt Anhydrous comes into contact with water or other liquids, creating a uniform emulsion that is characterized by small and homogenous droplets.

In one of two studies, we conducted a microscopic evaluation of droplet size formation for metronidazole 50 mg/mL anhydrous suspension prepared using SuspendIt Anhydrous (left) and Product B (right). When the samples were observed under the microscope at 4x magnification, the suspension using the PCCA SuspendIt Anhydrous showed a homogeneous dispersion (Figure 2). Product B displayed aggregation of metronidazole (Figure 3, highlighted with arrow) and separation of the water and oily phases (Figure 4, highlighted with arrow).

Figures 2-4.Microscopic evaluation of droplet size formation (4x objective lens) for metronidazole 50 mg/mL anhydrous suspension prepared using SuspendIt Anhydrous (left) and Product B (right).

The SEDDS in SuspendIt Anhydrous allows for the formation of a uniform emulsion, characterized by small and homogeneous droplets. As a result, the self-emulsifying properties of SuspendIt Anhydrous are likely to promote increased drug solubility, dispersibility, absorption and bioavailability.

Compatible with Nasogastric Feeding Tubes

Nasogastric feeding tubes are commonly used in patients when enteral nutrition is required. However, tube clogging remains a significant barrier to the delivery of drug and nutritional support — attention must always be paid to this potential complication. It is also essential that drug administered via a nasogastric tube preserves the correct API dose when exiting from the tube.

In one of several of studies, we evaluated the likelihood of compounded anhydrous suspensions (metronidazole 50 mg/mL, tretinoin 10 mg/mL or nifedipine 4 mg/mL) to block or leave residues in nasogastric feeding tubes. The resulting volume was measured; potency testing was determined by HPLC. Results indicated the amount of metronidazole, tretinoin or nifedipine recovered from the feeding tubes was >95% for SuspendIt Anhydrous.

Figure 1. Note how the SuspendIt Anhydrous formulation flows freely and does not cause clumping or blockage. Click the image to watch the video.

On the day after the recovery test, we observed that there were no significant drug residues throughout the nasogastric tube, nor at the exit of the tube, for the oral suspensions in SuspendIt Anhydrous (Figure 2). On the contrary, there was visible accumulation of drug residues for the corresponding Product A and Product B oral suspensions, which suggests potential tube clogging (Figures 3 and 4).

Figures 2-4. Nasogastric feeding tubes (exit) on the day after the recovery test for the metronidazole oral suspensions in PCCA SuspendIt Anhydrous and the corresponding Product A and Product B products.

To view details of the multiple studies conducted using SuspendIt Anhydrous, PCCA members can access the complete Science Manual on our Members-Only Website. PCCA members also have access to formulas developed for SuspendIt Anhydrous, including stability studies. Members with clinical services may contact our Clinical Services Team for help with formulas and other compounding concerns.

PCCA SuspendIt Presented at International Scientific Conferences

Wed, 09 Nov 2022 13:10:54 GMT

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

PCCA SuspendIt is a contemporary suspending vehicle that offers convenience and dosing flexibility for compounded medications. Throughout the years, the stability of standardized formulations for SuspendIt oral liquids has been studied and validated by PCCA, Eagle Analytical Services and other institutions, such as the College of Pharmacy at Xavier University of Louisiana (XULA).

PCCA SuspendIt is now featured in several United States Pharmacopeia (USP) monographs and it is currently one of the most studied oral vehicles in the compounding industry.

This year, the 80^thFIP (International Pharmaceutical Federation) World Congress of Pharmacy Congress was held in Seville, from September 18-22, in collaboration with the 22^nd Spanish National Pharmacy Congress. Together, there were more than 7,000 participants from over 100 countries attending both congresses, an impressive turnout!

To mark the special celebration of the 80^th FIP World Congress, PCCA presented a scientific poster summarizing the validated stability studies for 40 pediatric oral liquids. This was a great opportunity to demonstrate the science behind PCCA SuspendIt and the quality of the validated stability studies. Our research attracted a lot of attention from pharmacists worldwide who recognized the need to prepare palatable, uniform and stable oral liquids, particularly for pediatric patients.

PCCA members can access Scientific Publications and Formula Plus™ Studies on the PCCA Science webpage. PCCA members can also contact us at pccascience@pccarx.com.

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).

Introducing SuspendIt® Anhydrous - A Self-emulsifying suspension with extended stability

Wed, 02 Nov 2022 12:22:59 GMT

SuspendIt Anhydrous oral suspending vehicle offers improved taste, broader application and prolonged default beyond use dates (BUDs).It is Ideal for active pharmaceutical ingredients (APIs) that are unstable in water or have incompatibilities in some aqueous vehicles,

Its unique self-emulsifying system mixes nicely in aqueous liquids, while its thixotropic effect offers rapid redispersion of APIs with minimal sedimentation. And with water activity less than 0.6 (Aw<0.6), SuspendIt Anhydrous is classified as an anhydrous oral vehicle that, depending on the API used, allows pharmacy compounders to assign longer default BUDs.

Unlike traditional fixed oil suspensions and other oral anhydrous suspensions, SuspendIt Anhydrous mixes easily with water or juice to improve patient compliance. Mixing a single dose of the compounded medication with juice or other flavored liquids at time of administration helps disguise the medication’s taste, which may improve medication compliance in children, hospice patients and pets.

SuspendIt Anhydrous is compatible with polyurethane nasogastric (feeding) tubes for use in hospice, pediatric care and other healthcare settings.

Unique Characteristics of SuspendIt Anhydrous

SuspendIt Anhydrous is unlike any other oral suspension vehicle:

Self-emulsifying properties may improve the solubility, dispersibility and possibly enhance bioavailability of drugs with poor water-solubility.
Thixotropic effect potentially allows rapid redispersion of APIs upon agitation with potentially minimal sedimentation.
Extended BUDs for pharmacy and patient convenience.
May use with hydrophilic or lipophilic drugs.
Naturally sweetened with monk fruit for a more palpable taste.
Preservative free.
Offers improved palatability from traditional oil vehicles.
Mixes easily with water or juice.
Ideal for use in pediatrics, including neonates.
Appropriate for vet use (assess to ensure appropriate for the animal’s species).
Can be used in polyurethane nasogastric (feeding) tubes.

PCCA Chief Scientific Officer Gus Bassani, PharmD, took center stage to announce the launch of our innovative SuspendIt Anhydrous at International Seminar 2022 (ISTX22). “Our research and development Team had to really innovate to get the delivery, the feel and other physical attributes just right. I tell you, you haven’t seen one like this before.”

Access more information here.

PCCA Science Update: The Latest Scientific Publications

Mon, 08 Apr 2019 14:18:01 GMT

By Maria Carvalho, PharmD, MRPharmS, PhD

Every month, there are new scientific publications involving PCCA products or services. These publications include journal articles, conference abstracts, conference posters, technical reports and case studies. Journal articles, in particular, are the most prestigious and trustworthy publications in science. They are commonly peer-reviewed, which means that, prior to acceptance and publication, manuscripts go through a rigorous review process by international experts. Journal articles are also publications that pharmacies may use to support their compounded medications.

Below are five journal articles published recently online not only by PCCA authors, but also by independent researchers. You can always see the scientific publications involving PCCA products on the PCCA Science webpage, and you can read about some of our other recent publications here. Stay tuned for more PCCA Science updates!

Stability of Compounded Ursodiol Suspensions in PCCA Base, SuspendIt®
A stability study including Suspendit® published in the January/February 2019 issue of the International Journal of Pharmaceutical Compounding. Read the abstract here.
Serum Levetiracetam Concentrations after Transdermal Levetiracetam Administration, 3 Times Daily, to Healthy Cats
An article involving Lipoderm® published in the Journal of Veterinary Internal Medicine. Access the full article here.
Quality Control and Basics of Sterile Compounding: Attempting to Avoid Out-of-Specification Results and Patient Harm in Sterile Compounding
An article published in the January/February 2019 issue of the International Journal of Pharmaceutical Compounding. Read the abstract here,
Physicochemical Stability of Extemporaneously Prepared Methylcobalamin Injections in the Presence and Absence of Preservative and the Impact of Light Exposure
A stability study published in the March/April 2019 issue of the International Journal of Pharmaceutical Compounding. Read the abstract here.
Physicochemical Stability of Compounded Naltrexone Hydrochloride Solutions in PCCA Base SuspendIt®
A stability study including SuspendIt® published in the March/April 2019 issue of the International Journal of Pharmaceutical Compounding. Read the abstract here.

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 is also a reviewer of compounding articles for peer-reviewed journals and has authored or co-authored several scientific publications.