Preparation of delayed-release multiparticulate formulations of diclofenac sodium and evaluation of their dissolution characteristics using biorelevant dissolution methods

Żakowiecki, Daniel; Szczepanska, Maja; Hess, Tobias; Cal, Krzysztof; Mikolaszek, Barbara; Paszkowska, Jadwiga; Wiater, Marcela; Hoc, Dagmara; Garbacz, Grzegorz

doi:10.1016/j.jddst.2020.101986

Cited by 13 publications

(11 citation statements)

References 30 publications

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“…They contain 20% w/w MCC and the remaining 80% w/w is anhydrous calcium dihydrogen phosphate (DCPA). Like the pure MCC pellets, they are not water-soluble, so layering is a similarly simple and fast process [58,105,123].…”

Section: Types Of Starter Coresmentioning

confidence: 99%

“…beneficial properties and reducing its possibly avoidable effects is well k pellet cores based on dibasic calcium phosphate appeared on the market a They contain 20% w/w MCC and the remaining 80% w/w is anhydrous cal gen phosphate (DCPA). Like the pure MCC pellets, they are not water-solu is a similarly simple and fast process [58,105,123].…”

Section: Study Of the Behavior Of Starter Cores In Aqueous Medium Wit...mentioning

confidence: 99%

“…Zakowiecki et al used different types of starter cores, such as water-soluble sugar and isomalt cores, and water-insoluble MCC and DCPA starter core for the preparation of poorly-soluble diclofenac sodium-loaded enteric-coated pellet formulations. Their results showed that the water-insoluble cores resulted in a lower degree of diclofenac release in the acid phase compared to the formulations which are based on water-soluble cores [123]. In many cases, the pellets have permeable film coating.…”

Section: Dissolution Studies and Release Mechanism From Inert Core-ba...mentioning

confidence: 99%

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Review on Starter Pellets: Inert and Functional Cores

et al. 2022

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A significant proportion of pharmaceuticals are now considered multiparticulate systems. Modified-release drug delivery formulations can be designed with engineering precision, and patient-centric dosing can be accomplished relatively easily using multi-unit systems. In many cases, Multiple-Unit Pellet Systems (MUPS) are formulated on the basis of a neutral excipient core which may carry the layered drug surrounded also by functional coating. In the present summary, commonly used starter pellets are presented. The manuscript describes the main properties of the various nuclei related to their micro- and macrostructure. In the case of layered pellets formed based on different inert pellet cores, the drug release mechanism can be expected in detail. Finally, the authors would like to prove the industrial significance of inert cores by presenting some of the commercially available formulations.

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Section: Types Of Starter Coresmentioning

confidence: 99%

Section: Study Of the Behavior Of Starter Cores In Aqueous Medium Wit...mentioning

confidence: 99%

Section: Dissolution Studies and Release Mechanism From Inert Core-ba...mentioning

confidence: 99%

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Review on Starter Pellets: Inert and Functional Cores

et al. 2022

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“…The Physio-grad system has been used by Zakowiecki et al (2020) [40]. Both the Physio-Stat and Physio-Grad can be used in non-pharmacopeial systems and may be applicable to various models of the small intestine and colon.…”

Section: Supplementary Buffer Systemsmentioning

confidence: 99%

In vitro models to evaluate ingestible devices: Present status and current trends

O’Farrell

Stamatopoulos

Simmons

et al. 2021

Advanced Drug Delivery Reviews

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“…Limited friability of starter pellets is vital because it prevents the undesired dust formation, especially at the beginning of the coating process. A summary of DCPA pellets characteristics in comparison with other starter pellets can be found elsewhere [ 9 , 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

The Use of Calcium Phosphate-Based Starter Pellets for the Preparation of Sprinkle IR MUPS Formulation of Rosuvastatin Calcium

Cal

Mikolaszek

Hess³

et al. 2023

Pharmaceuticals

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Sprinkle formulations represent an interesting concept of medicinal products aimed at the steadily growing population of patients suffering from swallowing difficulties (dysphagia). In the present work, immediate-release sprinkle MUPS (multiple-unit pellet system) containing rosuvastatin calcium as a model drug substance was successfully developed. The formulation was prepared by drug layering technique using novel calcium phosphate-based starting pellets (PharSQ® Spheres CM) of three different particle sizes. The study showed that the developed multiparticulates were characterized by uniform distribution of coating layers thickness, as well as fast dissolution rate (more than 85% of rosuvastatin calcium dissolved within 30 min, as required by the relevant USP/NF monograph). Rosuvastatin calcium, like other statins, has a bitter, unpleasant taste. Investigations conducted with an electronic tongue suggested that the developed formulation achieved the desired taste-masking efficiency. The effect was found to be particle size-dependent, improving as the size of the multiparticulates increased.

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Preparation of delayed-release multiparticulate formulations of diclofenac sodium and evaluation of their dissolution characteristics using biorelevant dissolution methods

Cited by 13 publications

References 30 publications

Review on Starter Pellets: Inert and Functional Cores

Review on Starter Pellets: Inert and Functional Cores

In vitro models to evaluate ingestible devices: Present status and current trends

The Use of Calcium Phosphate-Based Starter Pellets for the Preparation of Sprinkle IR MUPS Formulation of Rosuvastatin Calcium

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