Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
Substance | Function | Distributor | Brand name |
---|---|---|---|
dimenhydrinate | drug | Pharma Roth (D) | |
modified pea starch polymer | film forming agent | Roquette (F) | Lycoat RS 720 |
glycerol (anhydrous) | plasticizer | Caesar & Loretz (D) | |
water | solvent | ||
ethanol abs. | co-solvent | VWR (D) | |
E 124 (red) | coloring agent | Caesar & Loretz (D) | |
hydroxypropyl-β-cyclodextrin | solubilizer taste | Roquette (F) | Kleptose® HPB oral grade |
masking agent | |||
maltodextrin (pea starch based) | solubilizer taste | Roquette (F) | Kleptose® linecaps |
masking agent | |||
sulfobutylether-β-cyclodextrin (+sodium salts) | solubilizer taste | Cydex (US) | Captisol® |
masking agent | |||
saccharin sodium | sweetener | Caesar & Loretz (D) |
2.2. Sample Preparation
Batch code: | D | P | DCA | PCA | DCD | PCD | DCDS | PCDS | DMD | PMD | DS | PS |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Dimenhydrinate | x | - | x | - | x | - | x | - | x | - | x | - |
HP-β-CD | - | - | - | - | x | x | x | x | - | - | - | - |
SBE-β-CD | - | - | x | x | - | - | - | - | - | - | - | - |
Maltodextrin | - | - | - | - | - | - | - | - | x | x | - | - |
Saccharin sodium | - | - | - | - | - | - | x | x | - | - | x | x |
2.3. Film Thickness and Weight
2.4. Drug Content
2.5. Determination of Disintegration time
2.6. Morphology
operational voltage | 40 kV |
---|---|
operational amperage | 40 mA |
angular step size | 0.0167113° 2 θ |
range | 10°-50° 2 θ |
scanning rate | 0.417782°/s |
2.7. Electronic Taste Sensing
Insent | α Astree | ||
---|---|---|---|
SB2AAE | umami | ZZ | Cross selective |
SB2CA0 | sourness | AB | |
SB2CT0 | saltiness | BA | |
SB2AE1 | astringency | BB | |
SB2AC0 | bitterness | CA | |
SB2AN0 | bitterness | DA | |
SB2C00 | bitterness (anionic) | JE |
3. Results and Discussion
3.1. Film Properties
Thickness (µm) | Weight (µm) | Drug content | Disintegration time | ||||
---|---|---|---|---|---|---|---|
(mg) | AV | Q (%) | Drop (s) | Petri dish (s) | |||
D | 143.4 ± 7.2 | 59.4 ± 2.3 | 4.7 ± 0.1 | 0.5 | 94.8 | 35.5 ± 7.8 | 29.1 ± 4.8 |
P | 136.6 ± 7.0 | 55.6 ± 1.7 | - | - | - | 49.0 ± 5.9 | 21.0 ± 1.7 |
DCA | 114.7 ± 3.2 | 50.5 ± 1.8 | 5.2 ± 0.1 | 0.3 | 104.5 | 27.4 ± 8.6 | 11.3 ± 1.1 |
PCA | 116.0 ± 6.7 | 51.2 ± 3.3 | - | - | - | 36.0 ± 9.4 | 10.9 ± 1.7 |
DCD | 158.0 ± 3.4 | 64.8 ± 1.1 | 4.7 ± 0.1 | 2.7 | 94.0 | 117.9 ± 9.3 | 41.7 ± 5.5 |
PCD | 142.4 ± 25.4 | 66.8 ± 2.7 | - | - | - | 62.0 ± 17.0 | 30.6 ± 3.4 |
DCDS | 171.2 ± 7.5 | 71.9 ± 3.0 | 5.6 ± 0.1 | 0.9 | 112.4 | 104.4 ± 8.2 | 36.6 ± 4.1 |
PCDS | 152.7 ± 6.7 | 67.1 ± 5.2 | - | - | - | 78.1 ± 8.2 | 35.9 ± 3.4 |
DMD | 125.0 ± 2.3 | 55.3 ± 2.6 | 5.0 ± 0.1 | 0.1 | 100.1 | 41.1 ± 10.6 | 15.5 ± 0.5 |
PMD | 119.4 ± 9.4 | 52.2 ± 3.3 | - | - | - | 31.7 ± 6.0 | 12.9 ± 0.5 |
DS | 156.6 ± 11.4 | 64.9 ± 3.9 | 5.5 ± 0.4 | 1.2 | 109.2 | 74.7 ± 20.1 | 26.4 ± 3.0 |
PS | 127.5 ± 7.6 | 53.4 ± 2.7 | - | - | - | 85.0 ± 15.7 | 20.5 ± 3.6 |
3.2. Morphology
3.3. Taste Assessment by Electronic Taste Sensing Systems
4. Conclusions
Acknowledgments
Conflict of Interest
References
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Preis, M.; Pein, M.; Breitkreutz, J. Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate. Pharmaceutics 2012, 4, 551-562. https://doi.org/10.3390/pharmaceutics4040551
Preis M, Pein M, Breitkreutz J. Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate. Pharmaceutics. 2012; 4(4):551-562. https://doi.org/10.3390/pharmaceutics4040551
Chicago/Turabian StylePreis, Maren, Miriam Pein, and Jörg Breitkreutz. 2012. "Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate" Pharmaceutics 4, no. 4: 551-562. https://doi.org/10.3390/pharmaceutics4040551