Extrusion/Spheronization as a Granulation Technique

Background: At present, there were numerous researches on the migration of components in tablets and granules, the investigation in the pharmaceutical literatrue concerning the effect of drying rate on the migration of water-soluble components of pellets was limited. Temperature and relative humidity (RH) were crucial parameters during the drying process which was an essential step in the preparation of pellets via wet extrusion/spheronization. To quantify these variables, the water loss percentage of pellets per minute was defined as drying rate. Objective: The study aimed to investigate the influence of drying rate on the migration of water-soluble components in wet pellets and the potential migrated mechanism. Methods: The pellets containing tartrazine as a water-soluble model drug and microcrystalline cellulose as a matrix former were prepared by extrusion/spheronization and dried at four different drying temperature and relative humidity. Afterward, the extent of migrated tartrazine was assessed regarding appearance, in-vitro dissolution test, Differential Scanning Calorimetry, X-Ray Powder Diffraction, Attenuated total reflectance Fourier transform infrared spectroscopy and Confocal Raman Mapping. Results: Results demonstrated that red spots of tartrazine appeared on the surface of pellets and more than 40% tartrazine were burst released within 5 minutes when pellets dried at 60℃/RH 10%. While pellets dried at 40℃/RH 80%, none of these aforementioned phenomena was observed. Conclusion: In conclusion, the faster drying rate was, the more tartrazine migrated to the exterior of pellets. Adjusting drying temperature and relative humidity appropriately could inhibit the migration of water-soluble components within wet extrusion/spheronization pellets.

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Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique

Recent Patents on Drug Delivery & Formulation ◽

10.2174/1872211310666160709193540 ◽

2016 ◽

Vol 10 (3) ◽

pp. 192-206

Author(s):

Hetal Patel ◽

Kishan Patel ◽

Sanjay Tiwari ◽

Sonia Pandey ◽

Shailesh Shah ◽

...

Keyword(s):

Quality By Design ◽

Extrusion Spheronization

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A Review on Enteric Coated Pellets Composed of Core Pellets Prepared by Extrusion-Spheronization

Recent Patents on Drug Delivery & Formulation ◽

10.2174/1872211313666190212115139 ◽

2019 ◽

Vol 13 (2) ◽

pp. 83-90 ◽

Cited By ~ 1

Author(s):

Hetal Patel ◽

Mukesh Gohel

Keyword(s):

Dosage Form ◽

Extended Release ◽

Rapid Onset ◽

Enteric Coating ◽

Onset Of Action ◽

The Core ◽

Current State ◽

Enteric Coated ◽

Extrusion Spheronization ◽

Acid Labile

Enteric coated dosage form bypasses the stomach and releases the drug into the small intestine. Advantages of enteric coated pellets in comparison with enteric coated tablets are a) Pellets provide rapid onset of action and faster drug release due to the smaller size than tablets and b) Pellets exhibit less residence time of acid-labile drugs in the stomach compared to tablets. Dosage form coat can be damaged by longer resistance time in the stomach. The present review summarizes the current state of enteric coated pellets where core pellets are prepared by extrusion-spheronization technique and the enteric coating is applied in a fluidized bed processor. Two approaches are involved in the preparation of core pellets. In the first approach, a mixture of drug and excipient(s)/co-processed excipient is passed through extruders to prepare core pellets. In the second approach, excipient core pellets are prepared by extrusion technique and the drug is layered onto it before the enteric coating. The excipients present in the core pellets decide immediate or extended release of drug in the intestine. The coprocessed excipient pellets provide less batch variability and provide a platform for layering of many drugs before enteric coating. Some patents included enteric coating pellets [CN105456223 (A), CN105596310 (A), CN105616371 (A), CN105663095 (A), CN101611766B, CN106511862 (A), CN106668018 (A), CN106727381 (A), CN106924222 (A), TW200624127 (A), US 2017/0165248A1, US 2017/0224720A1] are discussed.

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A STUDY ON DIFFERENT PELLET FORMATION TECHNIQUES AND ITS EVALUATION PARAMETERS-A REVIEW

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2019v11i2.33020 ◽

2019 ◽

pp. 7-13

Author(s):

REHANA BEGUM A. ◽

GANESH N. S. ◽

VINEETH CHANDY

Keyword(s):

Oral Administration ◽

Particle Production ◽

Dosage Forms ◽

Review Article ◽

Spheroidal Particle ◽

Safety And Efficacy ◽

Pellet Production ◽

Pellet Formation ◽

Evaluation Parameters ◽

Extrusion Spheronization

This review article deals with the various pelletization techniques utilized in the pharmaceutical industry for spheroidal particle production i.e., pellet for mainly oral administration which can be further formulated into several other dosage forms such as tablets, capsules or can be administered as such. Now-a-days oral administration has become the most versatile, convenient and common route of drug administration which ultimately focuses on patient compliance. The technique which is setting horizon in pelletization is “Extrusion Spheronization” because of its simple and easy steps involved in pellet production in a faster way. This review also includes the characterization and evaluation of pellets to ensure its quality, safety and efficacy to give out the required therapeutic activity after administration.

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