Application properties of oral gels as media for administration of minitablets and pellets to paediatric patients

Kluk, Anna; Sznitowska, Małgorzata

doi:10.1016/j.ijpharm.2013.10.052

Cited by 30 publications

(18 citation statements)

References 15 publications

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“…Unfortunately, this creates a risk of interactions between the drug and the food ingredients (12,13), however, this risk can be much reduced by using a standard dispersing medium/carrier. The dispersing medium can be in the form of a semisolid gel composed of a hydrophilic organic polymer (14). In comparison to syrups or other liquids, semisolid dispersing vehicles may facilitate oral application due to the smooth texture and lubricating effect.…”

Section: Pharmaceutical Technologymentioning

confidence: 99%

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

Szczepanska¹,

Scanu²,

Sznitowska³

2020

Acta Poloniae Pharmaceutica - Drug Research

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Minitablets are small tablets (1-3 mm in diameter) that can be easily swallowed by children. When administered in a certain number of units they enable flexible dosing for a broad range of age in pediatric patients. They can be designed as a modified-release formulation. Administration of a larger number of minitablets to small children may be possible with a standard polymeric hydrogel which facilitates swallowing. Enteric-coated minitablets (2 and 3 mm) with diclofenac sodium were developed and the main goal was to evaluate how carbomer and sodium carmellose gels influence the in vitro drug release from minitablets. The cores of minitablets composed of microcrystalline cellulose, lactose, pregelatinized maize starch, sodium starch glycolate, colloidal silica and sodium stearyl fumarate were coated with Eudragit L. Not only enteric film thickness but also the size of minitablet cores had a critical significance for the release of diclofenac. Smaller minitablets (2 mm) with thinner film thickness (40 µm) released diclofenac in pH 6.8 buffer quickly, however, larger cores (3 mm) with the same film thickness swelled in the acidic medium and in effect very slow drug release in the buffer phase was observed. The application of a thicker film (60 µm) eliminated this problem. Mixing of minitablets with a carmellose gel caused a prolonged release of diclofenac in the buffer stage. This effect was largely reduced if a carbomer gel was used as a dispersing medium, but still, the drug release was slower than from loose minitablets or minitablets filled in a gelatin capsule.

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Section: Pharmaceutical Technologymentioning

confidence: 99%

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

Szczepanska¹,

Scanu²,

Sznitowska³

2020

Acta Poloniae Pharmaceutica - Drug Research

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“…The molecule contains a high percentage of carboxylic acid groups, allowing it to swell in water and produce a certain viscosity; this characteristic is the basis of its mucoadhesive capacity. The oral hydrogels prepared with carbomer are suitable for dispersing and delivery of minitablets or pellets and then they can be used also in paediatric patients (8).…”

Section: Main Textmentioning

confidence: 99%

Evaluation of in vivo adhesiveness of hyaluronic acid combined with xanthan gum and carbomer [Karos® throat lozenges] to the oral cavity mucosa in human healthy subjects: a pilot study

Bandiera¹,

Talamonti²,

Piccolino³

et al. 2019

Preprint

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Objective: The use of a hyaluronic acid-based product has the potential to improve the hydration status of the mucous membranes, especially in the oral cavity. This study has evaluated the in vivo adhesiveness of a product based on hyaluronic acid combined with xanthan gum and carbomer to the oral cavity mucosa in human healthy subjects. The product was administered to 10 healthy volunteers during two tests: in the first participants were asked to abstain from drinking and eating for the duration of the test; in the second participants were free to follow their daily routine. In both tests, samples were taken by brushing the oral cavity immediately after administration of the product, and then after each hour, up to 4 hours. A qualitative and quantitative analysis of the drug was carried out by observation of the samples stained with Alcian Blue at pH 2.5. Results: In both tests the analysis demonstrated the presence of the product in all collected samples, up to 4 hours after administration of the product, confirming that the combination of hyaluronic acid with xanthan gum and carbomer can provide a long-lasting, durable mucoadhesive hydrogel.Keywords: Adhesiveness, carbomer, hyaluronic acid, oral cavity mucosa, xanthan gum.

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“…Research is required in this area, where the utilization of robust predictive models to assess palatability is desired as it could avoid the hurdles of conducting clinical trials [41] . Meanwhile, oral gels and in situ gelling vehicles are being studied as media to aid the administration of multiparticulate formulations [42] . Multiparticulates can be directly administered into the patients’ mouth or dispersed in a vehicle prior to administration as preferred.…”

Section: Novel Approaches To Age-appropriate Oral Drug Deliverymentioning

confidence: 99%

Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms

Lopez¹,

Ernest

Tuleu³

et al. 2015

Expert Opinion on Drug Delivery

214

147

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Introduction: Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability. Areas covered: The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems. Expert opinion: Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.

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Application properties of oral gels as media for administration of minitablets and pellets to paediatric patients

Cited by 30 publications

References 15 publications

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

The Effect of Size of Enteric-Coated Minitablets and Type of the Dispersing Gel on the in Vitro Release of Diclofenac

Evaluation of in vivo adhesiveness of hyaluronic acid combined with xanthan gum and carbomer [Karos® throat lozenges] to the oral cavity mucosa in human healthy subjects: a pilot study

Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms

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