Combination of a hot-melt subcoating and an enteric coating for moisture protection of hygroscopic Sennae fructus tablets

The objective of this study was to investigate the efficiency of moisture protection of hot-melt coatings solely and in combination with an enteric coating on hygroscopic tablet cores containing a spray-dried Sennae fructus extract. Tablet cores were subcoated with different hot-melt coating materials: medium chain tryglycerides, stearic acid, Precirol® ATO 5, and Compritol® 888 ATO, at varying amounts and coated with Eudragit® L 30D-55 for enteric resistance. Subcoating penetration, tablet disintegration, dissolution times, tablet hygroscopicity, and tablet properties such as weight, height, diameter, and hardness were analyzed. 3 mg/cm2 of tablet surface seemed to be sufficient if sustained release is not required. Thereby, hot-melt coating did not adversely affect the tablet properties with regard to subsequent processing steps. Compared to the tablet cores it was possible to reduce the moisture uptake by 85% at 75% relative humidity with tablets coated with a combination of Precirol® ATO 5 and Eudragit® L 30D-55. This combination was more efficient than high amounts of Eudragit® L 30D-55. Hot-melt coating proved to be a suitable technique for the application of subcoating material to tablet cores serving as a barrier against water permeation into hygroscopic tablet cores without exceeding the required disintegration times.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:24

Enthalten in:

Pharmaceutical development and technology - 24(2019), 10 vom: 28. Dez., Seite 1210-1217

Sprache:

Englisch

Beteiligte Personen:

Zier, Kira-Isabel [VerfasserIn]
Schultze, Wulf [VerfasserIn]
Leopold, Claudia S [VerfasserIn]

Links:

Volltext

Themen:

25086-15-1
8013-11-4
Disintegration time
Enteric coating
Hot-melt coating
Hygroscopicity
Journal Article
Laxatives
Methylmethacrylate-methacrylic acid copolymer
Moisture-sensitive tablets
Polymethacrylic Acids
Senna Extract
Sennae fructus
Spray-dried extract
Tablets, Enteric-Coated

Anmerkungen:

Date Completed 13.04.2020

Date Revised 13.04.2020

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1080/10837450.2019.1648509

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM299656721