scholarly journals A STUDY OF FLUID BED GRANULATION OF PRAVASTATIN TABLET USING DESIGN OF EXPERIMENTS

2018 ◽  
Vol 11 (10) ◽  
pp. 410
Author(s):  
Kang Min Kim ◽  
Jae Sung Pyo
Keyword(s):  
Risk Assessment ◽  
Design Of Experiments ◽  
Bulk Density ◽  
Wet Granulation ◽  
Inlet Temperature ◽  
Product Temperature ◽  
Fluid Bed ◽  
Spray Rate ◽  
Potential Factors ◽  
Quality By Design Approach

Objective: The objective of this study was to reduce size and weight of pravastatin tablet through quality by design approach; potential factors (spray rate, atomizing pressure, and inlet temperature) which could influence on the production process for critical process parameters of wet granulation using fluid-bed granulator were examined.Methods: The manufacturing process of the reduced weight and size formulation pravastatin tablet involves wet granulation, drying, granulate screening, blending, and tableting. Design of experiments study for wet granulation of the reduced weight/size pravastatin tablet was produced on 11 combinations of three factors (spray rate, atomizing pressure, and inlet temperature), which were chosen through initial risk assessment. The process of wet granulation was rated by measuring four responses: loss on drying (LOD) (%), bulk density (g/ml), product temperature (°C), and dissolution similarity (f2).Results: It was measured that LOD varied from 1.46 to 3.24%, bulk density from 0.34 to 0.51 g/ml, product temperature from 40.12 to 51.69°C, and dissolution (f2) of pravastatin from 52.14 to 58.91. Control strategy for wet granulation production of the reduced weight and size pravastatin tablet by our results demonstrated that the most optimized condition of three factors for wet granulation is spray rate (3–5 g/min), atomizing pressure (about 1 bar), and inlet temperature (65–90°C), respectively. Updated risk assessment and justification by all experimental data safely existed within the range of acceptance criteria were presented.Conclusion: It can be concluded that the ideal ranges of three factors (spray rate, atomizing pressure, and inlet temperature) in wet granulation were successfully identified.

scholarly journals The Influence of Equipment Design and Process Parameters on Granule Breakage in a Semi-Continuous Fluid Bed Dryer after Continuous Twin-Screw Wet Granulation

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 293
Author(s):  
Alexander Ryckaert ◽  
Michael Ghijs ◽  
Christoph Portier ◽  
Dejan Djuric ◽  
Adrian Funke ◽  
...  
Keyword(s):  
Process Development ◽  
Wet Granulation ◽  
Major Goal ◽  
Drying Time ◽  
Process Step ◽  
Manufacturing Line ◽  
Fluid Bed ◽  
Twin Screw ◽  
Filling Phase ◽  
Twin Screw Granulation

The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality. Understanding the size reduction of pharmaceutical granules before, during, and after the fluid bed drying process is, however, still lacking. A first major goal was to investigate the breakage and attrition phenomena during transport of wet and dry granules, the filling phase, and drying phase on a ConsiGma-25 system (C25). Pneumatic transport of the wet granules after TSG towards the dryer induced extensive breakage, whereas the turbulent filling and drying phase of the drying cells caused rather moderate breakage and attrition. Subsequently, the dry transfer line was responsible for additional extensive breakage and attrition. The second major goal was to compare the influence of drying air temperature and drying time on granule size and moisture content for granules processed with a commercial-scale ConsiGma-25 system and with the R&D-scale ConsiGma-1 (C1) system. Generally, the granule quality obtained after drying with C1 was not predictive for the C25, making it challenging during process development with the C1 to obtain representative granules for the C25.

A combined experimental and computational study of wet granulation in a Wurster fluid bed granulator

2009 ◽  
Vol 189 (2) ◽  
pp. 190-201 ◽  
Author(s):  
P. Rajniak ◽  
F. Stepanek ◽  
K. Dhanasekharan ◽  
R. Fan ◽  
C. Mancinelli ◽  
...  
Keyword(s):  
Computational Study ◽  
Wet Granulation ◽  
Fluid Bed

scholarly journals End-Point Prediction of Granule Moisture in a ConsiGmaTM-25 Segmented Fluid Bed Dryer

Pharmaceutics ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 452
Author(s):  
Jakob Rehrl ◽  
Stephan Sacher ◽  
Martin Horn ◽  
Johannes Khinast
Keyword(s):  
Process Model ◽  
Operating Conditions ◽  
Pharmaceutical Manufacturing ◽  
Wet Granulation ◽  
Drying Time ◽  
Proposed Model ◽  
Fluid Bed ◽  
Continuous Dryer ◽  
Process Measurements ◽  
Validation Experiments

Continuously operated pharmaceutical manufacturing lines often consist of a wet granulation unit operation, followed by a (semi-) continuous dryer. The operating conditions of the dryer are crucial for obtaining a desired final granule moisture. Commercially available dryers lack of a thorough online measurement of granule moisture during the drying process. However, this information could improve the operation of the equipment considerably, yielding a granule moisture close to the desired value (e.g., by drying time and process parameter adjustments in real-time). The paper at hand proposes a process model, which can be parameterized from a very limited number of experiments and then be used as a so-called soft sensor for predicting granule moisture. It utilizes available process measurements for the estimation of the granule moisture. The development of the model as well as parameter identification and validation experiments are provided. The proposed model paves the way for the application of sophisticated observer concepts. Possible future activities on that topic are outlined in the paper.

Assessing the Explosion Risk of Plants for Dusty, Granular and Combustible Products Example of a Risk Assessment Procedure for a Fluid Bed Spray Granulator

2012 ◽  
Vol 508 ◽  
pp. 101-105
Author(s):  
Siegfried Radandt
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Assessment Procedure ◽  
Fluid Bed ◽  
Internal Context ◽  
Explosion Risk

Risk management is specific to the organization and its external and internal context. In this paper risk management and some concepts focusing specifically on such plants for dusty, granular and combustible products were introduced. Some examples were presented here for practical uses, which can be applied in dusty and complicated surroundings.

scholarly journals Preformulation Study of Pugun Tano (Curanga fel-terrae [Lour.] Merr) Ethanolic Extract Granule Mass in Capsule as Hepatoprotective Drug

2019 ◽  
Vol 7 (22) ◽  
pp. 3729-3732
Author(s):  
Urip Harahap ◽  
Marianne Marianne ◽  
Yuandani Yuandani ◽  
Lia Laila
Keyword(s):  
Bulk Density ◽  
Dosage Form ◽  
Corn Starch ◽  
Ethanolic Extract ◽  
Magnesium Stearate ◽  
Angle Of Repose ◽  
Wet Granulation ◽  
Hausner Ratio ◽  
Tapped Density ◽  
Preformulation Study

BACKGROUND: Pugun tano extract had been studied for its effect as hepatoprotector. However, the usage of the plant in the form of extract has a limitation, especially if the extract is consumed by the people due to the unpleasant taste and odour. Then, the extract needs to be transformed into a particular dosage form, such as a capsule. But before the capsule can be produced, a preformulation study of pugun tano extract into a granule mass in capsule need to be evaluated. AIM: The study aimed to formulate the ethanolic extract of pugun tano (Curanga fel-terrae (Lour.) Merr) as granule mass in the capsule dosage form. METHODS: The pugun tano ethanolic extract was formulated in several steps included preparation of dry extract using coating method with polyvinylpyrrolidone (PVP) and granule mass production. The excipients used for the granule mass were lactose granules (made with tapioca starch using wet granulation), corn starch (made with 3 concentrations of 5% (F1), 7.5% (F2) and 10% (F3)), talcum, magnesium stearate, methylparaben, and propylparaben. The granule mass was evaluated for the bulk density, tapped density, inter-particle porosity, Carr’s index, Hausner ratio, angle of repose, and flowability. RESULTS: The results showed that all of the formulae passed the requirement of the preformulation test. The bulk density of the granule mass was 0.79 – 0.86 g/ml; the tapped density was 0.88 – 0.90 g/ml; the inter-particle porosity was 0.03 – 0.14; the Carr’s index was 2.71 – 11.94%; the Hausner ratio was 1.09-1.12; the angle of repose was 26.10 – 28.90°; and the flowing time was 5.97 – 6.63 seconds. All of the formulae showed good flowability and free-flowing properties. CONCLUSION: It is concluded that the obtained formula

Sign in / Sign up

Export Citation Format

Share Document