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Dissolution Media Preparation
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With standard gravimetric dosing
Pharma Test Dissolution Media Preparation
Pharma Test dissolution media preparation systems are engineered to automate the laborious and critical process of creating, heating, and degassing the fluids required for drug release testing. In pharmaceutical dissolution analysis, the accuracy of the results is highly dependent on the quality of the media used. These systems utilize gravimetric dosing principles to ensure that concentrates and solvents are mixed with high precision, achieving the exact concentrations required by the monograph.
The technical core of these instruments lies in their highly efficient degassing and deaeration capabilities. Dissolved gases, such as oxygen and nitrogen, can form bubbles on the surface of the dosage form or the dissolution basket, significantly interfering with the release rate of the active ingredient. Pharma Test systems apply heat and vacuum simultaneously while the media is in motion to ensure that dissolved air is reduced to levels below 5.5 mg/L (as per USP recommendations).
Gravimetric Dosing and Mixing Accuracy
The systems employ high-precision load cells to perform gravimetric dosing of solvents and concentrates. Unlike volumetric methods, which are susceptible to temperature fluctuations and parallax errors, gravimetric measurement ensures that the mass of each component is recorded precisely.
High-Efficiency Vacuum Degassing and Deaeration
Deaeration is a critical technical step to prevent "bubble artifacts" during dissolution. Pharma Test instruments combine vacuum, heat, and vigorous circulation to strip dissolved gases from the media. By exposing a large surface area of the fluid to a vacuum under constant agitation, the system rapidly reaches the required oxygen levels. This process is documented in real-time, providing the analytical proof that the media meets the deaeration standards before the dissolution run commences.
Integrated Media Heating and Thermal Stability
To save significant time in the lab, these systems pre-heat the media during the preparation and degassing phase. An integrated heating element allows the fluid to reach the standard 37 C (or other custom temperatures) before it is dispensed. This technical feature ensures that when the media enters the dissolution vessel, it is already at the target temperature, reducing the "warm-up" time required by the dissolution bath and ensuring that the dosage form is not subjected to temperature gradients.
Automated Vessel Filling and Volumetric Precision
Dispensing media into dissolution vessels is often a source of inconsistency. Pharma Test systems utilize calibrated dosing pumps and delivery lines to fill multiple vessels simultaneously or sequentially. The volume is controlled gravimetrically, and the dispensing nozzle is designed to minimize turbulence and prevent the re-introduction of air during the filling process. This ensures that every vessel in a 6 or 8-position bath contains the exact same volume of media, which is essential for valid statistical comparisons.
Buffer Preparation and pH Adjustment Capabilities
Many dissolution methods require complex buffer systems with specific pH values. These systems can be configured to mix concentrates, such as hydrochloric acid or phosphate buffers, with purified water. The automated mixing ensures that the ionic strength and pH are consistent across batches. This technical automation reduces the risk of chemical handling by laboratory personnel and ensures that the media's chemical properties are reproducible, which is vital for bioequivalence and stability studies.
Cleaning-In-Place (CIP) and Prevention of Cross-Contamination
To maintain the integrity of different dissolution runs, the preparation systems feature automated cleaning-in-place (CIP) routines. After a batch is dispensed, the system can be programmed to flush the lines and tanks with purified water or cleaning agents. This technical procedure ensures that no residue from a previous buffer or active ingredient remains in the system, preventing cross-contamination and ensuring that the next batch of media is chemically pure.
Precise Media Handling for Surfactant-Based Solutions
Media containing surfactants, such as Sodium Lauryl Sulfate (SLS), often presents challenges due to excessive foaming. Pharma Test systems are technically optimized to handle these solutions by controlling the vacuum levels and circulation speed. This prevents foam from entering the vacuum pump and ensures that the surfactant remains evenly distributed in the solution. The result is a bubble-free, homogenized media that is critical for testing poorly soluble drug formulations.
Data Integrity and Electronic Protocol Storage
In compliance with 21 CFR Part 11, the control software records every parameter of the media preparation process. This includes the weight of the components, the temperature achieved, the vacuum levels maintained during degassing, and the final volume dispensed. These electronic records provide a complete audit trail for the dissolution media, allowing laboratories to prove that the mobile phase was prepared exactly according to the validated method for every analytical batch.
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