The Integrated Homogenization and Deaeration Process Facilitates the High‑quality Industrialization of Oral Thin Film Materials
In recent years, with the development of novel oral drug delivery technologies, Oral Thin Films (OTF) have gradually become an important direction in the pharmaceutical formulation field, thanks to their advantages of swallowing‑free administration, rapid dissolution, and ease of use. Compared with traditional tablets and capsules, OTFs load active ingredients into a thin‑film carrier to achieve fast release and convenient dosing, making them particularly suitable for applications that require improved patient experience and higher compliance.
However, from laboratory R&D to scale‑up production, OTF manufacturing is not a simple material mixing process. The film‑forming solution typically contains multiple components—such as polymeric film‑forming materials, active pharmaceutical ingredients, plasticizers, and functional additives—resulting in high viscosity, complex formulation systems, and demanding uniformity requirements.
In actual production, the effectiveness of material mixing and deaeration directly affects subsequent coating stability, film thickness consistency, appearance quality, and uniformity of active ingredient distribution. Therefore, how to achieve rapid homogeneous mixing, efficient removal of micro‑bubbles, and stable control of material state has become a critical process challenge in OTF manufacturing.
1. Mixing and Deaeration Challenges in OTF Material Processing
- Dispersion non‑uniformity in multi‑component systems
OTF materials typically consist of polymers, active pharmaceutical ingredients, solvents, and various excipients. These components differ in viscosity, density, and dispersibility. Conventional stirring methods often result in local concentration inhomogeneities and long mixing times, affecting the consistency of the final film. - Micro‑bubble introduction during stirring
During high‑speed mixing, shear, turbulence, and air entrainment can generate a large number of micro‑bubbles within the system. If these bubbles are not effectively removed, they may cause pinholes, thickness variations, surface defects, and reduced product stability in subsequent coating processes. In the pharmaceutical field, bubble control is directly linked to product quality consistency. - Temperature rise affecting material stability
Many pharmaceutical materials are sensitive to processing temperatures. Excessive shear or prolonged operation during mixing may cause temperature increases, viscosity changes, and even degradation of some active ingredients. Therefore, temperature rise control must be considered alongside efficient mixing.
2. ZEY Vacuum Deaeration Mixers: Efficient Processing for OTF Materials
To address the mixing and deaeration requirements of OTF materials, ZEY Technology offers vacuum deaeration mixing solutions that support the entire journey from laboratory R&D to production scale‑up. In this trial, a client used the ZEY ZYMB‑20000VS Non‑Contact Material Homogenizer to validate the mixing and deaeration of their OTF material.
Client: A domestic pharmaceutical company
Material: Oral Thin Film formulation
Equipment: ZEY ZYMB‑20000VS Non‑Contact Material Homogenizer
▲ ZEY ZYMB‑20000VS Non‑Contact Material Homogenizer
Objective: Achieve complete material homogeneity and bubble‑free consistency.
3. Measured Data: Multi‑Stage Process Validation
① Stage 1: Material Homogeneous Mixing
Results: After processing with the ZEY homogenizer, the material exhibited uniform dispersion and a stable system state, with no visible bubbles generated during mixing.
② Stage 2: Vacuum Deaeration Treatment
Results: After centrifugal mixing under vacuum, micro‑bubbles within the material were effectively eliminated, and the system became more stable.
③ Stage 3: Temperature Rise Test During Operation
To verify temperature control performance during continuous operation, a temperature rise test was conducted. The results showed that the material temperature increase was minimal, helping to preserve material stability during processing.
Technical Advantages
- Dual action of vacuum + centrifugal force for efficient micro‑bubble removal – The combination of vacuum negative pressure and planetary centrifugal action thoroughly removes micron‑sized bubbles from the slurry, resulting in coating films free of pinholes, uniform thickness, and compliant drug content. No chemical defoamers are required, and lengthy static deaeration is eliminated, greatly reducing production time. Mixing and vacuum deaeration can be completed simultaneously in one step.
- Closed processing to reduce re‑entrainment of air – The equipment operates in a sealed environment, completely isolating the material from atmospheric oxygen to prevent air re‑entrainment and oxidative discoloration of drugs. The dust‑free, clean chamber meets GMP pharmaceutical manufacturing standards.
- Mixing, homogenization, and deaeration in one step – Traditional processes often require: mixing → standing → defoaming → re‑treatment, which is time‑consuming and may compromise material consistency. The ZEY vacuum deaeration mixer accomplishes mixing + homogenization + vacuum deaeration simultaneously, with no material splashing or loss, reduced manual intervention, and improved process stability.
- Parameterized control for smooth scale‑up from R&D to production – The equipment supports adjustable rotation speed, time settings, vacuum parameters, and process data recording. Optimal parameters developed during R&D can be directly applied to pilot‑scale and full‑scale production, improving batch‑to‑batch consistency.
4. From Material R&D to Industrialization – ZEY Powers Advanced Pharmaceutical Material Processing
As an important direction in novel drug delivery systems, oral thin films impose higher demands on material processing. This client validation demonstrates that the ZEY ZYMB‑20000VS Vacuum Deaeration Mixer effectively meets the requirements for efficient mixing, uniform dispersion, micro‑bubble control, and stable processing of OTF materials.
Looking ahead, ZEY Technology will continue to focus on high‑performance material applications in pharmaceuticals, biomaterials, electronic materials, new energy materials, and more, delivering more precise, efficient, and stable mixing and deaeration solutions to support our customers in accelerating new material product development and industrialisation.
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