In de farmaceutische industrie, veel tabletten geproduceerd door de tabletpers moet het tabletfilmcoatingproces na het eindproduct gebruiken om het uiterlijk van het medicijn te verbeteren, en de stabiliteit en functionaliteit ervan verbeteren. Coatingmachines zijn een belangrijk onderdeel van dit proces. In dit artikel gaan we dieper in op verschillende aspecten van het coatingproces van tabletfilms, zodat u begrijpt hoe u het proces kunt optimaliseren voor de beste resultaten.

Overzicht tabletfilmcoating

1.1 Wat is tabletfilmcoating?

Tabletfilmcoating is een techniek die wordt gebruikt om het oppervlak van farmaceutische tabletten met een dunne film te bedekken. De film, meestal gemaakt van een polymeermateriaal, beschermt de tablet tegen externe omgevingsinvloeden zoals vocht, zuurstof en licht. Tegelijkertijd, filmcoating verbetert de smaak en het uiterlijk van het medicijn, waardoor het concurrerender wordt op de markt. In het farmaceutische productieproces, filmcoating verbetert de stabiliteit van het geneesmiddel, maakt gecontroleerde afgiftesnelheden mogelijk, en verhoogt uiteindelijk de therapeutische werkzaamheid.

1.2 Application areas of film coating for tablets

Film coating of tablets has a wide range of applications in the pharmaceutical industry:

Enhancement of drug stability: coating can effectively isolate air and moisture to prevent oxidation or moisture, thus extending the shelf life of drugs.

Control of drug release: By designing different coating formulations, the release rate of drugs can be controlled to achieve slow release, controlled release and other effects to improve the therapeutic effect of drugs.

Improve the taste of drugs: For some drugs, film coating can mask the bitter taste or bad taste of the drug, making the drug easier to swallow.

Enhance the appearance of drugs: the beautiful coating enhances the market attractiveness of drugs and makes the products more competitive.

Werkingsprincipe van coatingmachine

2.1 Basisstructuur van coatingmachine

Coatingmachine is een soort automatische apparatuur, de hoofdstructuur omvat:

Sproeisysteem: het wordt gebruikt om de coatingvloeistof gelijkmatig op het tabletoppervlak te spuiten. Het ontwerp en de positie van de spuitmond zijn van cruciaal belang voor het coatingeffect.

Rotatie systeem: Zorgt voor een gelijkmatige rotatie van tabletten tijdens het coatingproces, waardoor een uniforme dekking ontstaat. De snelheid en hoek van het rotatiesysteem moeten worden aangepast op basis van specifieke vereisten.

Droogsysteem: Verwijdert oplosmiddelen uit de coatingoplossing door verwarming of luchtdroging om uitharding en hechting van de film te garanderen.

Besturingssysteem: omvat een bedieningspaneel en een controller voor het instellen en bewaken van verschillende parameters in het coatingproces, zoals spuitsnelheid, temperatuur en vochtigheid.

2.2 Process Flow of Film Coating of Tablets

The process flow of film coating usually includes the following steps:

Tablet pretreatment: before coating, tablets need to be cleaned and dried to ensure that the surface is free of impurities, which facilitates the uniform adhesion of the coating.

Preparation of coating solution: A suitable coating solution is prepared according to the requirements of the drug product. This usually involves the selection of suitable polymeric materials, solvents and additives and homogenous mixing.

Spraying process: The coating solution is uniformly sprayed onto the surface of the tablet by means of a spraying system to form a thin film. During the spraying process, the pressure and angle of the spray nozzle need to be adjusted to ensure uniformity of the coating.

Drying: The solvent in the coating solution is removed by a drying system to solidify the film. The drying process requires precise control of temperature and duration, tailored to the specific formulation of the coating solution.

Quality checking: quality checking of the coated tablets to ensure that the thickness of the film is uniform, firmly attached and free from defects.

Key elements of film coating process for tablets

3.1 Preparation of coating liquid

The preparation of coating liquid is crucial to the effect of film coating:

Solvent selection: the solvent should have good solubility properties and be able to fully dissolve the polymer material. Commonly used solvents include water and organic solvents.

Additives: lubricants, plasticizers and stabilizers are added as needed to improve the fluidity of the coating solution and the performance of the film.

Concentration control: The concentration of the coating solution should be adjusted according to the characteristics of the tablet and the coating requirements to ensure that the thickness of the film is moderate and uniform.

3.2 Temperature and humidity control in the coating process

The control of temperature and humidity has a direct influence on the coating quality:

Temperature control: The temperature during the coating process needs to be controlled in a suitable range to ensure the drying effect of the coating solution. Temperatures that are either too high or too low may result in issues with film quality.

Humidity control: too high humidity may lead to uneven drying of the coating solution, while too low humidity may lead to brittle film. Ensure the quality and stability of the film by reasonably controlling the humidity of the environment.

3.3 Operating parameters of coating machine

The operating parameters of the coating machine include:

Spraying speed: Spraying speed affects the uniformity of coating and film thickness. Adjustments should be made based on specific production requirements.

Rotation speed: the rotation speed affects the turning effect of tablets in the coating process to ensure that the coating liquid can evenly cover the surface of tablets.

Drying time: the drying time affects the curing effect of the film, which needs to be adjusted according to the formulation of the coating solution and production requirements.

Optimization of tablet film coating process

4.1 Common problems and solutions

The following problems may be encountered during the tablet film coating process:

Poor film adhesion: This may be caused by improper formulation of coating liquid or unreasonable setting of spraying parameters. Solutions include adjusting the concentration of coating solution and selecting suitable solvents.

Uneven coating: Commonly due to mismatch of spraying speed or rotation speed. Optimization of spraying and rotating parameters can be used to ensure uniform distribution of the coating solution.

Film cracking: may be due to high temperature or low humidity during drying. Adjust the drying temperature and humidity to ensure film integrity.

4.2 Suggestions for improving coating quality

In order to improve the coating quality, you may consider the following suggestions:

Choose the right coating machine: Ensure that the coating machine’s spraying system, rotating system and drying system meet the production requirements.

Adjust the process parameters: Optimize the spraying speed, rotating speed and drying time according to the actual production situation in order to obtain the best coating effect.

Improve the coating solution formula: Find the most suitable coating solution formula for your product through experiment and optimization to enhance the quality and function of the film.

Selection and maintenance of coating machine

5.1 Choosing the right coating machine

When choosing a coating machine, moet u rekening houden met de volgende factoren:

Apparatuurspecificatie: Selecteer de juiste apparatuurspecificatie op basis van de productieschaal en productkenmerken om ervoor te zorgen dat deze aan de productievereisten voldoet.

Productiecapaciteit: De productiecapaciteit van de coatingmachine moet worden afgestemd op het productieschema om de productie-efficiëntie te garanderen.

Technische ondersteuning: Kies een leverancier van apparatuur die goede technische ondersteuning en service biedt om de normale werking en het normale onderhoud van de apparatuur te garanderen.

5.2 Onderhoud en reparatie van coatingmachine

Om de stabiele werking van de coatingmachine op lange termijn te garanderen, regelmatig onderhoud en reparatie zijn vereist:

Schoonmaak: Reinig het coatingsysteem en het roterende systeem regelmatig om te voorkomen dat resterende coatingoplossing de prestaties van de apparatuur beïnvloedt.

Inspectie: Regularly inspect the equipment’s components, including the spray nozzle, rotating system, and drying system, to ensure they are functioning correctly.

Maintenance: Follow the equipment manufacturer’s recommendations for maintenance, including lubrication and replacement of wearing parts, to extend the life of the equipment.

Conclusie

Tablet film coating process is of great significance in pharmaceutical production. By mastering the working principle of the coating machine, optimizing the process parameters and selecting the right equipment, you can significantly improve the quality and stability of the drug. Reasonable maintenance of the coating machine to ensure its long-term stable operation will help you get the best results in production.