The Pro Guide to Choosing a Drug Dissolution Tester Pump

Just as solvents are crucial in breaking down pharmaceutical compounds, a well-chosen microfluidic pump is essential to ensure accuracy, efficiency, and reliability throughout the drug dissolution process. Yet, finding the right pump for your testing requirements can seem like staring at a complex dissolution curve! Let's dissolve any uncertainty by guiding you through what drug dissolution entails, the key pump qualities to look for, and how Fluid Metering can help you make the best selection for your dissolution tester design.

What is Drug Dissolution?
Drug dissolution is a process used in pharmaceutical development to measure the rate at which an active pharmaceutical ingredient (API) is released from a solid dosage form (pill or tablet) into a solution. This process is critical in determining how the drug will be absorbed in the body. The rate of drug dissolution can influence the drug's bioavailability and efficacy, as well as patient safety.

Dissolution testers are designed to mimic the conditions of the stomach, allowing researchers to measure the rate of dissolution, the amount of time the drug remains active, and how well the body absorbs it. These devices also play a vital role in quality control, ensuring each pill or tablet is as identical as possible for consistent efficacy.

Types of Drug Dissolution Testing
There are several ways in which the drug's release and absorption can be studied:

1. Immediate-Release Dissolution

• Measures how quickly an immediate-release drug dissolves in the stomach and is available for absorption.
• Used for fast-acting drugs, like painkillers or fever reducers.

2. Extended-Release (Controlled-Release) Dissolution

• Evaluates how a drug gradually releases over time, ensuring a sustained therapeutic effect.
• Used for long-acting medications with reduced dosing frequency.

3. Delayed-Release Dissolution

• Examines drugs that bypass the stomach and dissolve in the intestines.
• Used for enteric-coated tablets, which protect the drug from stomach acid.

4. USP Apparatus-Based Dissolution Testing

• Uses standard United States Pharmacopeia (USP) dissolution apparatus to simulate drug release conditions:
  
  
  • USP 1 (Basket Method): Drug is placed in a rotating basket submerged in a liquid medium.
  • USP 2 (Paddle Method): Drug is stirred in the medium using a paddle.
  • USP 3 (Reciprocating Cylinder): Mimics drug release in changing pH conditions (ideal for extended-release drugs).
  • USP 4 (Flow-Through Cell): Continuous flow system ideal for poorly soluble drugs.

5. Biorelevant Dissolution Testing

• Uses simulated fluids like gastric juices to mimic real physiological conditions.
• Helps predict how the drug behaves in the human body under different conditions.
  
  

What Pump Specifications Should an Engineer Look For?
When selecting a pump for a drug dissolution application, several qualities are important:

• Flow Rate Control: The pump must provide the ability to vary flow rate while keeping the number of pulses constant.
  

• Chemical Compatibility: It should be resistant to water, hydrochloric acid (HCl), simulated gastric fluids, pepsin, bile salts, buffering agents, and other organic solvents used in dissolution tests.

• Reliability and Efficiency: The pump must deliver precision and accuracy, maintaining stable flow rate even at low volumes, and should be robust enough to withstand wear from repeated use over time.
  
  

Which Pumps Meet the Criteria?
Fluid Metering's CeramPump^® valveless technology utilizes a rotating, reciprocating ceramic piston design to provide long-term, drift-free fluid control without the need for check valves. This ensures superior reliability and precision in dissolution testing.

Often, when companies use generic pumps, they require around 300 individual components in their dissolution tester for the fluidic systems alone. This complex architecture leads to increased maintenance requirements and long-term costs. However, by switching to Fluid Metering's FENYX Variable Dispense pump, the number of fluidic components can be reduced down to about 30, eliminating the need for syringes, tubing, priming pumps, fittings, and other fluidic elements.

The FENYX can mimic natural stomach conditions by running at a constant speed while varying flow rate using a linear actuator. Competitors often lack this technology, forcing the OEM engineer to either purchase a separate unit altogether or to take extra time, money, and resources to design their own.

Solving the Drug Dissolution Dilemma
At Fluid Metering, we recognize the challenges in developing effective drug dissolution testers and offer expert engineering guidance to help OEM engineers select the optimal pump for their unique application requirements. Contact us today for help solving your drug dissolution dilemma!