Sep. 06, 2021
The ODF machine is specifically designed to make films from liquid materials. It can be used to make instant oral film agents, permeable film agents and oral freshener strips, and has a wide range of applications in the pharmaceutical and food industries.
The machine works by applying a uniform layer of liquid material to the surface of the roll base roller. The solvent (moisture) is quickly evaporated and dried through the drying channels. After cooling, the roll is wound up. The end product of the film is then obtained. Here GF-TECH shares with you some parameters for the evaluation of oral films.
The thickness of the film is measured by means of a digital vernier caliper. The thickness of the film should be in the range of 5-200 μm. The thickness should be assessed at five different locations (four corners and one centre) and the uniformity of the film thickness must be determined as this is directly relevant to ensure the accuracy of the dose distribution in the film.
Tensile strength is the maximum stress applied to a strip specimen at the point of fracture. It is calculated by dividing the load applied at fracture by the cross-sectional area of the strip.
The surface pH of quick release strips can have side effects on the oral mucosa, therefore it is necessary to assess the surface pH of the film. The surface pH of the film should be 7 or close to neutral. For this purpose, a combined pH electrode can be used.
The required organoleptic properties that fast dissolving preparations should have are colour, flavour and taste. As the formulation will disintegrate in the mouth, it should provide acceptable sensory palatability characteristics. The colour makes the formulation acceptable to the patient and, in addition, the oral film agent should have an attractive colour when administered to children. The formulation should therefore have a homogeneous and attractive colour.
Another sensory characteristic is the smell. The flavouring agents used in the formulation should provide a good odour to the formulation. Flavouring agents should be used to mask the odour of polymers, drugs and any other excipients. Taste is also an important factor that must be assessed.
Tear resistance is the resistance offered by the film when some load or force is applied to the film sample. The main applied load rate is very low. Tear resistance is measured in Newtons or pounds of force. In other words, it is the maximum force required to tear a specimen.
To determine the percentage moisture loss, the film sample is cut and weighed accurately on an electronic balance. After weighing, the film is stored in a desiccator containing molten anhydrous calcium chloride. The film should be kept in the desiccator for 72 h. After 72 h, the film is removed and weighed again to measure the percentage moisture loss of the film.
Folding endurance imparts brittleness to a film. The endurance value is determined by repeatedly folding the film sample in the same position until it breaks or visible cracks are observed. The number of times the film is folded without breaking or without visible cracks is the calculated folding resistance value.
Stability studies should be carried out in accordance with the International Conference on Harmonisation (ICH) guidelines. Prepared formulations are wrapped in a special manner. First wrapped in greaseproof paper, then in aluminium foil and then heat sealed in aluminium bags. The storage conditions for preserving the formulation should be 30°C/60% relative humidity. After 3 months, the films are evaluated for drug content, disintegration time and visual observations.
Fast dissolving strips can be packaged in single bags, multi-unit blister cards, multi-unit dispensers and continuous roll dispensers. There are a number of patented packaging systems for fast dissolving films, check GF-TECH's oral film making machine line.
Our strengths: round-the-clock customer service centre; skilled maintenance team, engineers available to repair machinery overseas. With a team of experts, technical support and a wide range of spare parts, feel free to contact us for a quote and specific details.
