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Development and uniformity evaluation of low-dose medicated chewing gums prepared by compression method
Summary
Medicated chewing gums (MCGs) with lysozyme hydrochloride and ascorbic acid were developed. Wet granulation improved blend flow and ensured drug uniformity, meeting European Pharmacopoeia standards.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Developing medicated chewing gums (MCGs) requires careful consideration of active ingredient homogeneity.
- Lysozyme hydrochloride (LH) exhibits poor flow properties, posing challenges for uniform incorporation into dosage forms.
Purpose of the Study:
- To develop MCGs containing lysozyme hydrochloride (LH) and ascorbic acid (AsA) using a compression method.
- To evaluate the impact of different preparation methods on blend flow and drug distribution.
Main Methods:
- MCGs were prepared using Health in Gum® (HiG®) PWD 01 as a gum base.
- Two blend preparation methods were compared: simple mixing versus wet granulation.
- Flow properties and drug content uniformity were assessed according to European Pharmacopoeia (Ph.Eur.) standards.
Main Results:
- Ascorbic acid (AsA) and HiG® showed good flow, while LH had poor flow.
- Wet granulation significantly improved the flow properties of the final blend compared to simple mixing.
- MCGs produced via wet granulation met Ph.Eur. 2.9.40 requirements for uniformity, unlike those from simple mixing.
Conclusions:
- Wet granulation is a superior method for preparing MCGs with low drug content and poor-flowing active ingredients like LH.
- This method ensures improved blend flowability and achieves the required drug content uniformity in the final MCGs.
Keywords:
ascorbic aciddrug content uniformitylysozyme hydrochloridemass uniformitymedicated chewing gumsuniformity of dosage unitsMore Related Videos
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