OralTop-Series Oral Thin Film making machine is specially designed and manufactured for making medicine film on paper, plastic film, metal film,etc. The active ingredient can be either dissolved or suspended in the polymeric matrix. OralTop-Series is used for making roll type Oral Thin Film.
Oral Thin Films with systemic activity for rapid delivery. An Oral Thin Film (OTF) is a very thin film, composed of a mono or multi-layer polymeric matrix, which is applied in the mouth. OTF are often water based soluble polymers designed to rapidly deliver drugs systematically. Depending on the drug candidate and the targeted indication, OTF can be formulated either as:
1. Orodispersible films working like conventional orodispersible tablets. In this case OTF dissolves within seconds in the mouth and the drug substance is swallowed together with the saliva and takes the same route as a tablet.
2. Or as a transmucosal film, where the active substance directly enters the systemic circulation via the buccal mucosa, avoiding the hepatic first pass effect.
The OTF dosage form presents several advantages, among which:
1. An easy drug intake therefore high acceptance by young and old patient thanks no swallowing difficulties and no beverages requirement for intake.
2. Flexible manufacturing with area proportional dosage (different doses from one base bulk).
3. Potential avoidance of the first-pass effect and improved bioavailability.
4. Innovative and appealing design offering more options for differentiating a product range.
Main Feature:
1. Coating thickness from 40 – 1000 microns wet.
2. High coating accuracy.
3. Individual temperature adjustment zones.
4. Recording of all process related parameters.
5. Variable speed of base film.
6. Uniform air flow throughout the machine.
7. cGMP Construction.
8. Liquid dosing system with peristaltic pump.
9. Thickness checking or wet & dry film.
Options
1. Products temperatures & film temperature measurement.
2. Recording of critical process data in 21 CFR part 11 certified software.
3. Report on excel file can be exported to USB to view on computer.
4. Equipment can be modified to make patch film of desired size and desired web length.
5. Cutting and Sitting line are a part of the complete processing line for oral strips.
6. Cutting line for cutting into small uniform strips & individual strip packing line.
7. Customer required designs and style / colors for printing.
8. Homogenizers and mixing tanks for integrations for a complete MDF suite.
9. Special style / shape for packing each film / multiple films.
Item | Specification |
Model | OralTop-300 |
Max.Production Width | 300mm |
Max. Line Speed | 10m/min (depend on medicine) |
Drying/Heating Method | Stainless Steel Heat Exchanger |
Temperature Range | 20-150℃ |
Total Power | 18kw |
Power Supply | 380v 50hz three phase or 220v 50hz three phase |
Overall Dimension | 2700*1200*2300mm |
weight | 2800kg |
Product Contact Parts Material | SS316L |
Control System | PLC and Touch Screen control |
Machine Frame Material | SUS304 |