A series of x-rays for the three animals treated with long-acting formulation–2 are shown in Fig. 2D.
Fig. 2D shows X-ray images of the smart pill containing long-acting formulation–2 over 29 days. Two arms of the pill broke off in pig 3, but the pill was still able to remain in the stomach and provide consistent drug concentrations.
a drug-polymer matrix within the sleeve
For extended release, the birth control pill (levonorgestrel (LNG)) can be loaded within the structural polymer that makes up the arms.
gastric resident dosage form
A pill that stays in the stomach during drug release.
The serum concentration of levonorgestrel in pigs treated with Levora tablets is shown in Fig. 2A.
Fig. 2A shows the concentration of the drug from a Levora tablet in a pig over the course of 2 days. The concentration reaches it's peak of 199 ± 56 pg/ml (n = 5) at around 6 hours and by 48 hours dropped to 5 ± 4 pg/ml (n = 5).
We then tested the stability of the interface between the material used to make the central elastomer (Elastollan 1185A10) and the arms of the dosage form (Sorona 3015G NC010) using a cyclic cantilever test. Over a 3-week period, there was progressive weakening of the interface (Fig. 1D).
This method helps determine the load that can be repeatedly applied to the joint area between the central elastomer and the arms while still keeping its structural integrity.
arms that had V-shaped grooves in them
This arm design was initially used because of the higher surface area it allowed in comparison to the other designs.
understanding the mechanical stability of the polymer at low pH
Tests are performed in order to understand how this specific polymer reacts when introduced to different pH levels. These are done to ensure the polymer is stable in the low pH of the stomach.
three-point bending test
The three-point bend test provides values for the modulus of elasticity, and flexural stress and strain.
Modulus of elasticity is the ratio of the stress in a body to the corresponding strain.
Flexural stress is the maximum bending stress that can be applied to that material before it breaks.
Flexural Strain is the ratio of stress to strain in flexural deformation, or the tendency for a material to resist bending.
the caged arms had a significantly higher fracture force than V-shaped arms (65.6 ± 7.5 N, n = 6 versus 51.7 ± 5.8 N, n = 6; P < 0.05, Student’s t test).
The caged arms fracture force was significantly higher than the V-shaped arms. The three-point bend test shows that it takes a higher force to break the caged arms than it takes to break the V- shaped arms.
the caged arms made using a thermoplastic polymer,
The arms were made out of a thermoplastic polymer which is a substance that can be heated to become pliable, and upon cooling, it hardens.
mechanical properties of V-shaped arms
Different forces were applied to the material. The physical reactions to those forces were noted in order to determine the mechanical properties of this material.
Examples of Mechanical Properties: strength, toughness, brittleness, etc..
an outer sleeve made of a rigid polymer that provides mechanical integrity (structural polymer)
The polymer making up the outer sleeve is for structural support of the dosage form.