Related Experiment Video
Updated: Jun 4, 2026
04:28
Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals
Published on: March 23, 2016
Orally disintegrating mini-tablets (ODMTs)--a novel solid oral dosage form for paediatric use
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Düsseldorf, Germany. Ines.Stoltenberg@uni-duesseldorf.de
Summary
Developing orally disintegrating mini-tablets (ODMTs) offers a novel solution for paediatric medicine administration. Ludiflash excipient demonstrated superior performance in creating child-appropriate ODMTs meeting key quality standards.
Area of Science:
- Pharmaceutical Technology
- Paediatric Drug Delivery
Background:
- New European regulations and WHO recommendations necessitate innovative paediatric dosage forms.
- Existing challenges in paediatric medication administration require child-friendly alternatives.
Purpose of the Study:
- To develop orally disintegrating mini-tablets (ODMTs) suitable for paediatric patients.
- To evaluate the suitability of five co-processed mannitol-based excipients for ODMT manufacturing.
Main Methods:
- Direct compression of five ready-to-use tableting excipients into 2 mm mini-tablets.
- Evaluation of drug-free and hydrochlorothiazide-loaded ODMTs for crushing strength, friability, and wetting time.
- Assessment of content uniformity according to pharmacopoeial specifications.
Main Results:
- ODMTs were successfully produced using all five investigated excipients.
- All ODMTs met pharmacopoeial specifications for crushing strength (>7 N), friability (<1%), and wetting time (<5 s).
- Ludiflash excipient yielded ODMTs with optimal crushing strength (7.8–11.8 N) and wetting times (3.1–5.0 s).
Conclusions:
- Orally disintegrating mini-tablets (ODMTs) are a viable and promising dosage form for paediatric use.
- Ludiflash demonstrated excellent performance, supporting its use in paediatric ODMT development.
- ODMTs represent a novel platform technology for future paediatric drug delivery applications.
Related Concept Videos
01:27Drug Delivery Systems: Different Types
Conventional oral drug products, termed immediate-release (IR) formulations, are engineered to promptly release their active pharmaceutical ingredient (API) upon ingestion, typically in tablets or capsules. This rapid release often results in swift drug absorption and consequent pharmacodynamic effects, although the timing and intensity can vary depending on the drug's properties. Prodrugs within these formulations require metabolic conversion to activate their pharmacodynamic effects,...
01:23Oral Drug Delivery Systems: Introduction
Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
01:26Oral Drug Delivery Systems: Continuous-Release Systems
Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...
01:11Oral Drug Delivery Systems: Delayed-Release Systems
Delayed-release drug delivery systems are specialized pharmaceutical formulations designed to postpone the release of active compounds until the drug reaches a specific region of the gastrointestinal (GI) tract, typically the intestine. These systems are essential for drugs that may cause gastric irritation, are unstable in acidic environments, or need to exert therapeutic effects locally in the intestinal or colonic regions.The core feature of delayed-release systems is the use of enteric...
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...