Development of a veterinary orodispersible film with a focus on spectrophotometric quantification of gabapentin
Lindfors, Lisa (2021)
Lindfors, Lisa
2021
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi-fe2021051730222
https://urn.fi/URN:NBN:fi-fe2021051730222
Tiivistelmä
To this day, there are no veterinary gabapentin dosage forms available on the market in Finland. Therefore, off-label treatment with human-marketed gabapentin, or compounded dosage forms thereof, are employed in the treatment of epilepsy and pain in cats and dogs. This practice is suboptimal, as there are significant risks of preparation errors and under- or overdosing from manually dividing capsules and tablets. A veterinary formulation, which could be safely and rapidly manufactured at the point-of-care, is needed. However, a hurdle in the development of such small-dose gabapentin dosage forms is the quantification of the gabapentin molecule. Ultraviolet-visible (UV-Vis) spectrophotometric quantification possesses suitable properties for implementation at small production sites, but quantifying gabapentin with the said technique has proven to be challenging as the small molecule is lacking chromophores.
This study aimed to thoroughly assess UV-Vis spectrophotometric gabapentin quantification methods with the intent of finding a reliable method applicable to a veterinary formulation. As a proof-of-concept, an orodispersible film formulation of gabapentin was developed and characterized. A selection of different quantification methods was assessed; one method, based on derivatization of gabapentin with ascorbic acid, stood out as the most precise and robust method. The method exhibited excellent linearity (R2 = 0.9998) in a wide and useful concentration range (0.5–40 μg/ml) at a detection wavelength of 376 nm. The method was successfully applied to the developed formulation for reliable determination of the drug content. The quality of the orodispersible film formulation was assessed according to pharmacopoeial tests and additional analyses. The polymeric films were easy to prepare by solvent casting, and they possessed good mechanical strength and thickness uniformity, neutral surface pH, rapid drug release, and satisfactory disintegration time.
This study proved that pet-friendly gabapentin dosage forms can be easily manufactured and analyzed. The findings can be implemented in practice, for example, in pharmacies, veterinary clinics, and animal hospitals. The findings are a step towards the much-needed goal of improved, safer, and more personalized gabapentin treatment of cats and dogs.
This study aimed to thoroughly assess UV-Vis spectrophotometric gabapentin quantification methods with the intent of finding a reliable method applicable to a veterinary formulation. As a proof-of-concept, an orodispersible film formulation of gabapentin was developed and characterized. A selection of different quantification methods was assessed; one method, based on derivatization of gabapentin with ascorbic acid, stood out as the most precise and robust method. The method exhibited excellent linearity (R2 = 0.9998) in a wide and useful concentration range (0.5–40 μg/ml) at a detection wavelength of 376 nm. The method was successfully applied to the developed formulation for reliable determination of the drug content. The quality of the orodispersible film formulation was assessed according to pharmacopoeial tests and additional analyses. The polymeric films were easy to prepare by solvent casting, and they possessed good mechanical strength and thickness uniformity, neutral surface pH, rapid drug release, and satisfactory disintegration time.
This study proved that pet-friendly gabapentin dosage forms can be easily manufactured and analyzed. The findings can be implemented in practice, for example, in pharmacies, veterinary clinics, and animal hospitals. The findings are a step towards the much-needed goal of improved, safer, and more personalized gabapentin treatment of cats and dogs.
Kokoelmat
- 317 Farmasia [19]