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Aqueous Polymeric Coating for Orally Disintegrating Lozenges

Mellberg, Hanna LU (2018) KLGM15 20181
Food Technology and Nutrition (M.Sc.)
Abstract
Polymeric film coating is widely used in the pharmaceutical industry as a way of improving the features of a dosage form. Common polymers used for pharmaceutical coating are hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA).

Coatings can have various benefits, one being protection of the active pharmaceutical ingredient (API). For a dosage form to be stable, it is necessary that excipients used in the coating and core are compatible with each other and with the API.

The aim of this work was to evaluate polymer based film formers for coating of orally disintegrating red fruit-flavored lozenges, to see if some are better suited for the API in question. Tablet cores were coated with film forming solutions containing... (More)
Polymeric film coating is widely used in the pharmaceutical industry as a way of improving the features of a dosage form. Common polymers used for pharmaceutical coating are hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA).

Coatings can have various benefits, one being protection of the active pharmaceutical ingredient (API). For a dosage form to be stable, it is necessary that excipients used in the coating and core are compatible with each other and with the API.

The aim of this work was to evaluate polymer based film formers for coating of orally disintegrating red fruit-flavored lozenges, to see if some are better suited for the API in question. Tablet cores were coated with film forming solutions containing different polymers and then analyzed. To compare the barrier qualities and moisture uptake of films, experiments were carried out on cast films. Since the sensory properties of an orally disintegrating lozenge are of great importance, a series of sensory evaluations were performed during the project.

Results from experiments on cast films indicated that PVA, as expected due to its high crystallinity, is a better moisture barrier and less hygroscopic than HPMC. Sensory evaluations continually favored tablets coated with HPMC, which is known to have a smooth feel compared to PVA. A double-coated lozenge with a thin layer of PVA and a thicker layer of flavored HPMC displayed a slower dissolution than tablets with only HPMC coating. However, sensory tests still indicated migration of API to the coating during accelerated stability testing, contradicting the theory that PVA would be an efficient barrier. The moisture uptake of the double-coated lozenges was found to be equal to that of the original formulation.

It was concluded that the PVA/HPMC double coating would not substantially improve the stability of the red fruit lozenges. Introducing desiccant in the flip packs used as the primary packaging for the lozenges did however seem to decrease API migration to the coating, and could be a way of enhancing the stability of the formulation. (Less)
Popular Abstract (Swedish)
Många av oss äter dagligen läkemedel i tablettform, men vad innehåller egentligen en tablett, förutom den aktiva ingrediensen? Och hur vet man om de andra ingredienserna passar ihop när man gör tabletten? I ett projekt under våren har olika polymerer testats för filmdragering av en tablett som löser upp sig i munnen.
Please use this url to cite or link to this publication:
author
Mellberg, Hanna LU
supervisor
organization
alternative title
An explorative study of the properties of different immediate release film formers
course
KLGM15 20181
year
type
H2 - Master's Degree (Two Years)
subject
keywords
pharmaceutical technology, läkemedelsteknologi
language
English
id
8952106
date added to LUP
2018-06-27 14:19:21
date last changed
2018-06-27 14:19:21
@misc{8952106,
  abstract     = {Polymeric film coating is widely used in the pharmaceutical industry as a way of improving the features of a dosage form. Common polymers used for pharmaceutical coating are hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA). 

Coatings can have various benefits, one being protection of the active pharmaceutical ingredient (API). For a dosage form to be stable, it is necessary that excipients used in the coating and core are compatible with each other and with the API.

The aim of this work was to evaluate polymer based film formers for coating of orally disintegrating red fruit-flavored lozenges, to see if some are better suited for the API in question. Tablet cores were coated with film forming solutions containing different polymers and then analyzed. To compare the barrier qualities and moisture uptake of films, experiments were carried out on cast films. Since the sensory properties of an orally disintegrating lozenge are of great importance, a series of sensory evaluations were performed during the project.

Results from experiments on cast films indicated that PVA, as expected due to its high crystallinity, is a better moisture barrier and less hygroscopic than HPMC. Sensory evaluations continually favored tablets coated with HPMC, which is known to have a smooth feel compared to PVA. A double-coated lozenge with a thin layer of PVA and a thicker layer of flavored HPMC displayed a slower dissolution than tablets with only HPMC coating. However, sensory tests still indicated migration of API to the coating during accelerated stability testing, contradicting the theory that PVA would be an efficient barrier. The moisture uptake of the double-coated lozenges was found to be equal to that of the original formulation.

It was concluded that the PVA/HPMC double coating would not substantially improve the stability of the red fruit lozenges. Introducing desiccant in the flip packs used as the primary packaging for the lozenges did however seem to decrease API migration to the coating, and could be a way of enhancing the stability of the formulation.},
  author       = {Mellberg, Hanna},
  keyword      = {pharmaceutical technology,läkemedelsteknologi},
  language     = {eng},
  note         = {Student Paper},
  title        = {Aqueous Polymeric Coating for Orally Disintegrating Lozenges},
  year         = {2018},
}