Preparation of pellets containing highly soluble drug by extrusion/spheronisation and coating with Kollicoat® SR 30D

Andreazza, Itamar Francisco; Ferraz, Humberto Gomes

doi:10.1590/s1516-89132011000200013

“…MMF model of dissolution in the current study, that was shown in the curve of Figure 4, is different from the pattern shown by other researchers [15,20]. This is an area for extended research to elucidate the variation in the dissolution due to pellets engineering.…”

Section: Resultscontrasting

confidence: 80%

Untitled

2018

NTNF

0

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With the advancement in the manufacturing industry of the food additive and supplements coupled with ever-increasing challenges in the health risk hazards, the establishment of strict control measures become essential to ensure product quality and safety. A small firm for manufacturing of food supplements and additives established a production line for a new product based on L-ascorbic acid (vitamin C) 500mg per hard gelatine capsule. Ascorbic Acid is provided as sustained release pellets. One of the important quality control tests that should be inspected was the dissolution profile after one, four and eight hours. Dissolution rate test was performed for 70 consecutive batches and results were interpreted. The best-fitting model that described the dissolution rate was Morgan-Mercer-Flodin (MMF) Model which is Sigmoidal four parameter mathematical curve. Establishment of Control Limits (CLs) was determined for each chronological test point using commercial statistical software package. Control limits standard deviations (sd) for one, four and eight hours were 28.1%±3.5%, 68.1%±4.1% and 89.4%±3.3%, respectively. On the other hand, the calculated lower and upper control limits (LCL, UCL) were (21.1%, 35.1%), (59.3%, 77.0%) and (81.6%, 97.2%), respectively. Interestingly, no Out-Of-Specification (OOS) results were detected for individual lots of product, yet UCLs exceeded Upper Specification Limits (USLs). This shift in the dissolution rate process is evident, especially in four hours point. Within/Overall Capability plots confirmed this finding with strong shift was detected to the right side that indicated a crucial need for investigational analysis. Accordingly, Statistical Process Control (SPC) provided provision for early warning of deviations in the manufacturing process cycle of the product before any true excursions may occur. The selection of product that has simple manufacturing processing steps such as Vitamin C will aid in the spotting of the most probable causes of hidden deviations which may be related to consistency of raw materials quality and/or laboratory system related-deviations.

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“…MMF model of dissolution in the current study, that was shown in the curve of Figure 4, is different from the pattern shown by other researchers [15,20]. This is an area for extended research to elucidate the variation in the dissolution due to pellets engineering.…”

Section: Resultscontrasting

confidence: 80%

Quality Criteria Establishment for Dissolution of Ascorbic Acid from Sustained Release Pellets

Eissa

¹

2018

NTNF

0

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With the advancement in the manufacturing industry of the food additive and supplements coupled with ever-increasing challenges in the health risk hazards, the establishment of strict control measures become essential to ensure product quality and safety. A small firm for manufacturing of food supplements and additives established a production line for a new product based on L-ascorbic acid (vitamin C) 500mg per hard gelatine capsule. Ascorbic Acid is provided as sustained release pellets. One of the important quality control tests that should be inspected was the dissolution profile after one, four and eight hours. Dissolution rate test was performed for 70 consecutive batches and results were interpreted. The best-fitting model that described the dissolution rate was Morgan-Mercer-Flodin (MMF) Model which is Sigmoidal four parameter mathematical curve. Establishment of Control Limits (CLs) was determined for each chronological test point using commercial statistical software package. Control limits standard deviations (sd) for one, four and eight hours were 28.1%±3.5%, 68.1%±4.1% and 89.4%±3.3%, respectively. On the other hand, the calculated lower and upper control limits (LCL, UCL) were (21.1%, 35.1%), (59.3%, 77.0%) and (81.6%, 97.2%), respectively. Interestingly, no Out-Of-Specification (OOS) results were detected for individual lots of product, yet UCLs exceeded Upper Specification Limits (USLs). This shift in the dissolution rate process is evident, especially in four hours point. Within/Overall Capability plots confirmed this finding with strong shift was detected to the right side that indicated a crucial need for investigational analysis. Accordingly, Statistical Process Control (SPC) provided provision for early warning of deviations in the manufacturing process cycle of the product before any true excursions may occur. The selection of product that has simple manufacturing processing steps such as Vitamin C will aid in the spotting of the most probable causes of hidden deviations which may be related to consistency of raw materials quality and/or laboratory system related-deviations.

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