PREPARATION AND SCALE-UP STUDY OF TREATED FAMOTIDINE FOR THE DEVELOPMENT OF ORALLY DISINTEGRATING TABLETS USING A COMPLEX FLUIDIZED-BED GRANULATOR EQUIPPED WITH A PARTICLE-SIZING MECHANISM

Objective: Bitter taste-masked drug substance should be needed for the development of orally disintegrating tablets (ODT). We selected a new type of a complex fluidized-bed granulator equipped with a particle-sizing mechanism for treating famotidine (FAM). This study was conducted to demonstrate the critical process parameter, which controls particle size of treated FAM, to determine its acceptable particle size considering uniformity of assay and to perform scale-up study from a laboratory scale to a commercial scale.Methods: Particle size of treated FAM was evaluated by changing spraying air pressure on the operation of a complex fluidized-bed granulator. Uniformity of assay in granules after blending and tablets were compared at different particle size of treated FAM. On the scale-up study, particle size and assay of treated FAM in both scales were evaluated.Results: The particle size of treated FAM decreased as the increase in spraying air pressure in relation to the spraying mist size. Better uniformity of assay was observed when the diameter of treated FAM was 20 µm compared to that of 50 µm. Therefore, target particle size of treated FAM was set at approximately 20 µm. Similar qualities could be obtained between both scales in the points of particle size and assay.Conclusion: On the operation of a complex fluidized-bed granulator, spraying air pressure was the critical process parameter that controlled particle size of treated FAM. On Scale-up study of treated FAM, spraying air pressure in relation to the spraying mist size was important.

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STUDIES IN PROSPECTIVE PROCESS VALIDATION OF ALLOPURINOL USP AS ACTIVE PHARMACEUTICAL INGREDIENT

INDIAN DRUGS ◽

10.53879/id.58.10.11608 ◽

2021 ◽

Vol 58 (10) ◽

pp. 42-50

Author(s):

Hemant S. Kandle ◽

Sangram S. Patil ◽

Sujata S. Sawant ◽

Ganesh B. Vambhurkar ◽

Asha M. Jagtap ◽

...

Keyword(s):

Active Pharmaceutical Ingredient ◽

Process Parameter ◽

Regulatory Requirements ◽

Validation Data ◽

Process Validation ◽

Critical Process Parameter ◽

Quality Control Testing ◽

Quality Product ◽

High Degree ◽

Critical Process

Allopurinol USP batches of same size, method, equipment and validation criterion were taken. The critical process parameter involved were reaction, drying, milling, sifting, milling, and blending stages were validation. Quality cannot be assured by daily quality control testing because of the limitations of statistical samples, and the limited facilities of finished product testing. Validation checks the accuracy and reliability of process. Aim of this work was to study prospective process validation of allopurinol USP designed to meet the current regulatory requirements and prove with assurance that the product meets the predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging its in house and compendial specification. Three initial process validations batches APL/008, APL/009 and APL/010 were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance so that manufacturing process produces a quality product.

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Scale up considerations in fluidized bed granulation: Air flow rates and air pressure distribution

Journal of Pharmacy and Pharmacology ◽

10.1111/j.2042-7158.1974.tb10100.x ◽

1974 ◽

Vol 26 (S1) ◽

pp. 76P-76P ◽

Cited By ~ 3

Author(s):

D. CAMPY ◽

T. EAVES ◽

E. M. GRUDZINSKI ◽

H. E. C. WORTHINGTON

Keyword(s):

Pressure Distribution ◽

Fluidized Bed ◽

Air Flow ◽

Scale Up ◽

Air Pressure ◽

Flow Rates

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Research of the True Flow with High Polymers as a Critical Process Parameter

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.490-491.34 ◽

2014 ◽

Vol 490-491 ◽

pp. 34-37

Author(s):

Xian Wei Wang ◽

Guang Liang Cheng

Keyword(s):

Intermolecular Interaction ◽

Process Parameter ◽

Polymer Materials ◽

Practical Significance ◽

Fixed Temperature ◽

Polymer Swelling ◽

Chain Flexibility ◽

Critical Process Parameter ◽

Critical Process ◽

True Flow

In this article should be noted that the accuracy of determining the viscosity of the flow is particularly low in the highly elastic with state of the polymer. It is therefore very important to identity the viscosity of the flow, which has great practical significance. solidity can be changed as a result of intermolecular interaction which can be observed in the process of polymer swelling, which means improving its chain flexibility and lowering the temperature of vitrifying. It should be noted that the processing of the experiment showed no pronounced dependence of the voltage, so it is under-read as the average results for all levers of the stress at a fixed temperature. Processed a method for determining the viscosity of polymer materials, which allows you to divide segmental strength and toughness of the true flow.

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Critical process parameter identification of manufacturing processes of Astragali Radix extract with a weighted determination coefficient method

Chinese Herbal Medicines ◽

10.1016/j.chmed.2019.11.001 ◽

2020 ◽

Vol 12 (2) ◽

pp. 125-132 ◽

Cited By ~ 2

Author(s):

Min-fei Sun ◽

Jing-yi Yang ◽

Wen Cao ◽

Jing-yuan Shao ◽

Guo-xiang Wang ◽

...

Keyword(s):

Parameter Identification ◽

Process Parameter ◽

Manufacturing Processes ◽

Astragali Radix ◽

Determination Coefficient ◽

Critical Process Parameter ◽

Critical Process ◽

Coefficient Method

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Effect of Particle Size on Carbon Nanotube Aggregates Behavior in Dilute Phase of a Fluidized Bed

Processes ◽

10.3390/pr6080121 ◽

2018 ◽

Vol 6 (8) ◽

pp. 121 ◽

Cited By ~ 3

Author(s):

Sung Kim

Keyword(s):

Particle Size ◽

Carbon Nanotube ◽

Fluidized Bed ◽

Laser Sheet ◽

Scale Up ◽

Experimental Parameter ◽

Aggregate Size ◽

Chemical Vapor ◽

Gas Velocity ◽

Effect Of Particle Size

Fluidized bed reactors have been increasingly applied for mass production of Carbon Nanotube (CNT) using catalytic chemical vapor deposition technology. Effect of particle size (dp = 131 μm and 220 μm) on fluidization characteristics and aggregation behavior of the CNT particles have been determined in a fluidized bed for its design and scale-up. The CNT aggregation properties such as size and shape were measured in the dilute phase of a fluidized bed (0.15 m-ID × 2.6 m high) by the laser sheet technique for the visualization. Two CNT particle beds showed different tendency in variations of the aggregates factors with gas velocity due to differences in factors contributing to the aggregate formation. The CNT particles with a larger mean size presented as relatively larger in the aggregate size than the smaller CNT particles at given gas velocities. The aggregates from the large CNT particles showed a sharp increase in the aspect ratio and rapid decrease in the roundness and the solidity with gas velocity. A possible mechanism of aggregates formation was proposed based on the variations of aggregates properties with gas velocity. The obtained Heywood diameters of aggregates have been firstly correlated with the experimental parameter.

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Modelling of Fluidized Bed Reactors

International Journal of Chemical Reactor Engineering ◽

10.2202/1542-6580.1118 ◽

2003 ◽

Vol 1 (1) ◽

Cited By ~ 1

Author(s):

Joachim Werther ◽

Ernst-Ulrich Hartge

Keyword(s):

Particle Size ◽

Particle Size Distribution ◽

Fluidized Bed ◽

Residence Time ◽

Time Distribution ◽

Residence Time Distribution ◽

Scale Up ◽

Fluidized Bed Reactor ◽

Fluidized Bed Reactors ◽

Model Calculations

The fluidized bed reactor has a lot of advantages: excellent gas-solid contacting, no hot spots even with highly exothermal reactions, good gas-to-particle and bed-to-wall heat transfer and the ease of solids handling which is particularly important if the catalyst is quickly ageing. However, the list of disadvantages is as long: broad residence time distribution of the gas due to dispersion and gas-bypass in the form of bubbles, broad residence time distribution of solids due to intense mixing, erosion of bed internals and the attrition of the catalyst particles. A particular disadvantage of the fluidized bed reactor is its difficult scale-up. The historical experience with the FCC process is that in the early 40's of the last century this process was successfully scaled up from a 5 cm dia. pilot-scale unit to a 4.5 m dia. bed in the production unit. On the other hand, around 1950 the scale up of the Fischer-Tropsch synthesis in the fluidized bed failed completely. Modern process design should be able to avoid such disasters by making use of modeling and simulation tools. However, a modeling tool which is really helpful in planning and designing of an industrial fluidized bed reactor has to fulfill a lot of requirements. It should be able to describe the influence of the several changes which are typical for the scale-up process, for example enlargement of bed diameter, bed height and fluidizing velocity, changes of gas distributor design, introduction of in-bed heat exchanger tubes and baffles. In the present work a modelling approach is presented which is able to handle the most important aspects of industrial fluidized bed reactors. A particular focus is to describe the relationship between catalyst attrition, solids recovery in the reactor system and chemical performance of the fluidized bed reactor. The competing influences of attrition of the catalyst particles and efficiency of the solids recovery lead to the establishment of a catalyst particle size distribution (PSD) in the bed inventory which in turn influences via the hydrodynamic characteristics of the fluidized bed the performance of the chemical reactor. The usefulness of this approach is illustrated with model calculations for a fictituous first order reaction where the fluidized bed is equipped with different solids recovery systems including one single stage cyclone, several cyclones in parallel, two- and three-stage cyclone systems, respectively. Model calculations illustrate the significance of a high efficiency of the solids recovery in order to keep the fines in the system which is decisive for a high performance of the reactor. The calculations reveal that it may take months until a quasi steady state of the bed particle size distribution is obtained.

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