Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation

Abstract

Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and children who have difficulty swallowing because of psychological or physiological deficiencies. This article describes the development of an ODF based on maltodextrin, which is easy to administer, has a pleasant taste, and is suitable for iron supplementation. An ODF containing 30 mg of iron as pyrophosphate and 400 µg of folic acid (iron ODF) was developed and manufactured on an industrial scale. The kinetic profile for serum iron and folic acid upon consumption of ODF compared with a Sucrosomial^® iron capsule (known for its high bioavailability) was evaluated in a crossover clinical trial. The study was conducted in nine healthy women, and the serum iron profile (AUC_0-8, T_max, and C_max) of both formulations was defined. Results showed that the rate and extent of elemental iron absorption with iron ODF was comparable to that obtained using the Sucrosomial^® iron capsule. These data represent the first evidence of iron and folic acid absorption concerning the newly developed ODF. Iron ODF was proven to be a suitable product for oral iron supplementation.

Keywords: bioavailability; convenient dosage form; food supplement; iron; maltodextrin; orodispersible film; patient acceptability.

Figure 1

Schematic crossover study design with 10 healthy volunteers. Test, iron ODF. Reference, Sucrosomial^® iron capsule.

Figure 2

Description of the ODF industrial manufacturing process. The solvent casting method used to manufacture ODFs consisted of several steps. 1: A liquid mixture was prepared (temperature and stirring speed are the critical process parameters). 2: The mixture was spread and dried in a drying tunnel by controlling temperature, air circulation, humidity, and coating speed. 3: The dried and spread-out mixture was wound to form a big roll, known as a jumbo roll. 4: The jumbo roll was unwound to underwent two consecutive cutting phases where the size of the film strips was selected, and the final dosage was defined. 5: The films are punched, pouched, and sealed in suitable single-dose sachets. Reproduced with permission from Cupone et al. [30].

Figure 3

A spread and dried mass cut into reels (a), iron ODF (b).

Figure 4

Viscosity of the ODF wet mixture as measured by changing test conditions. Dotted line: sample collected at the end of the coating step. Solid line: sample collected at the start of the coating step.

Figure 5

Viscosity curve.

Figure 6

The two cycles of the thixotropy test.

Figure 7

The last cycle of the thixotropy test with interpolated points highlighted using blue dots.

Figure 8

Disintegration apparatus at the start of disintegration test (a) and at the end (b).

Figure 9

Stability trend for iron ODF.

Figure 10

Mean change in serum iron concentration from baseline over 8 h after administration of 30 mg of test or reference product (n = 9). Test product: red line. Reference product: gray line.

Figure 11

Mean change in serum folic acid from baseline over eight hours after administration of 30 mg test or reference product (n = 9). Test product: red line. Reference product: gray line.