moisture activated dry granulation
220289386
Design, Optimization, and Correlation of In Vitro/In Vivo Disintegration of Novel Fast Orally Disintegrating Tablet of High Dose Metformin Hydrochloride Using Moisture Activated Dry Granulation Process and Quality by Design Approach
Compression of cohesive, poorly compactable, and high dose metformin hydrochloride into the orally disintegrating tablet (ODT) is challenging. The objective of this study was to develop metformin ODT using the moisture activated dry granulation (MADG) process. There are no reports in the literature regarding the development of ODT based on MADG technology. The feasibility of developing metformin ODT was assessed utilizing a 32 full factorial design to elucidate the influence of water amount (X1) and the amount of pregelatinized starch (PGS; X2) as independent variables on key granules and tablets' characteristics. The prepared granules and tablets were characterized for granule size, bulk density, flow properties, tablets' weight variation, breaking force, friability, capping tendency, in vitro and in vivo disintegration, and drug release. Regression analysis showed that X1 and X2 had a significant (p 0.05) impact on key granules and tablets' properties with a predominant effect of the water amount. Otherwise, the amount of PGS had a pronounced effect on tablet disintegration. Optimized ODT was found to show better mechanical strength, low friability, and short disintegration time in the oral cavity. Finally, this technique is expected to provide better ODT for many kinds of high dose drugs that can improve the quality of life of patients.
Pharmaceutics
Alhussain H Aodah Mohamed H Fayed Ahmed Alalaiwe Bader B Alsulays Mohammed F Aldawsari El-Sayed Khafagy
219492764
A REVIEW OVERALL INSIGHTS OF NOVEL MOISTURE ACTIVATED DRY GRANULATION TECHNOLOGY
Granulation is the most important step in tablet formulation when dealing with substances which are sensitive to moisture. The essential move depends on the success of the formulation. The present study focuses on the use of adapted granulation technology (GT) involving the use of least moisture while creating stable granules; the moisture activated dry granulation technique (MADG) .The technology overcomes problem of degradation of substances by water since it employs use of negligible amount of water (as moisture) The current article deals with in depth basic information about granule growth mechanisms during granulation and effectiveness over wet conventional wet granulation. Moisture Activated Dry Granulation (MADG) was created in response to the difficulties of endpoint, drying, and milling encountered with wet granulation. It also overcomes the problem of showing undesirable bimodal distribution in relation to having either too many fines or too many (or both) coarse particles in the granulation process. Key word: Granulation, Moisture activated dry granulation, Reasons of MADG Process of MADG.
Pankaj Kailas Deshmukh Abhijit Popat Ahirrao Santoshi Madhukarrao Deshmukh Vaibahv Arun Mahale Dr Vishal V Pande
136110174
Application of moisture activated dry granulation (MADG) process to develop high dose immediate release (IR) formulations
Abstract Moisture activated dry granulation (MADG) method was used to develop IR tablets with cohesive, fluffy and high dose drugs. To evaluate this approach, three drugs: metformin hydrochloride, acetaminophen and ferrous ascorbate were selected as model compound along with three binders: maltodextrin DE16, PVP K 12 and HPC. The granules were generated using MADG method and tablets were prepared using rotary tablet press. The granules and tablets were characterized for particle size analysis, flow properties, tablet hardness, friability, moisture content, dissolution study, disintegration time and stability study. All results were found to be within acceptable limits. Development of all formulation tablets were found as best fitted for an immediate release of Metformin hydrochloride, acetaminophen and ferrous ascorbate. MADG delivered a robust manufacturing process for generation of granules with excellent flowability. The tablets prepared using this method were found to show better content uniformity, good compactability and low friability. Use of this approach aids to lower the amount of excipients used to overcome physiochemical limitation of the drug substances and there side effects. Both drying and milling steps in wet granulation were not required for MADG process. MADG became a cost effective process which could lead to reduced total tablet size and also save time.
Kailas K Moravkar Tariq Ali Jaywant Pawar Purnima Amin
139185094
Review on Moisture activated Dry Granulation Process
Tablets are unit solid dosage form of medicament which largely used to compare other dosage form of medicaments. In tablet manufacturing, wet granulation and dry granulation methods largely used as compare to MADG process. In wet granulation and dry granulation methods various steps has been carried out like dispensing and shifting, dry mixing, granulation, pre drying, shifting, premixing, lubrication and compression. But in MADG process, escape various steps like slugging, pre drying, shifting, and drying. Hereby in MADG process save energy, cost of product and time also. The main object of review is hereby moisture activated dry granulation process very beneficial in case of water insoluble drug and water poorly soluble drug other than granulation method like wet granulation. Another objective of review how moisture activated dry granulation process carried out and given various advantages over the other granulation method. In water insoluble drug case MADG process largely used and very useful method for pharmaceutical industries.
Devender Sharma Satish B Kosalge Swati N Lade
100672711
The effect of water activity on granule characteristics and tablet properties produced by moisture activated dry granulation (MADG)
Abstract This study evaluated the effects of changing the amount of added water for moisture activated dry granulation (MADG) on the resulting granule characteristics and tablet properties. Water soluble fillers and binders were pre mixed in a granulator, and the binder was activated by a small amount of water to form granules. The amount of added water was defined as the percentage of granulation water by mass to charged powder. Granules made with 0.0% 1.0% 1.5% 2.0% 2.5% 3.0% and 5.0% (w/w) added water were evaluated in this study. Furthermore, the effect of free water content on tablet characteristics was investigated by measuring water activity. The Hausner ratio (HR) of MADG granules is significantly decreased by increasing the amount of added water up to 1.0% (water activity over 0.39) However, the HR of MADG granules did not change with further increase in water activity (added water over 2.5% The free water content (water activity over 0.61, water added over 2.5% may reach a limit in improving the flowability of MADG granules. MADG tablet tensile strength was increased along with the increased water activity when the added water amount was from 0.0% to 2.5% However, MADG tablet tensile strength prepared with 3.0% or 5.0% added water was lower than in other tablets. Similarly, MADG tablet tensile strength was increased with increasing water activity from 0.0% to 2.5% added water. Yet, the magnitude of the negative slope between 2.5% and 5.0% added water was approximately ten times greater compared to the magnitude of the slope between 0.0% and 2.5% added water. By increasing the amount of added water over 2.5% the excess amount of free water may have caused the decreasing tensile strength of the MADG tablets. MADG tablet initial wetting was correlated with water activity, and free water content was shown to have significant impact on the initial wetting of MADG tablets. Furthermore, this association between free water content and initial wetting of MADG tablets had a significant impact on tablet disintegration. Free water content had a low or minor impact on tablet porosity and capillary wetting.
Hiroshi Takasaki Etsuo Yonemochi Masanori Ito Koichi Wada Katsuhide Terada
205327649
Importance of excipient wettability on tablet characteristics prepared by moisture activated dry granulation (MADG)
For moisture activated dry granulation (MADG) microcrystalline cellulose (MCC) or silicon dioxide is recommended for the moisture absorption stage. The aim of this study was to assess the suitability of alternative excipients as moisture absorbents with regard to the disintegration mechanism of resulting lactose based placebo formulations. Beside high and low moisture MCC grades, the additions of magnesium aluminometasilicate (MAMS) pregelatinized starch (S1500) crospovidone (Kollidon CL) and carmellose calcium (ECG 505) were evaluated. High shear granulation (HSG) was conducted as a reference process. The overall disintegration time of all tablets produced by MADG was significantly faster whereas hardness yield and mass variability were equal or superior compared to the HSG process. Powder wettability of the different moisture absorbents was identified to be a key driver for rapid disintegration, whereas tablet porosity had only a minor influence on the target hardness of the tablets.
International journal of pharmaceutics
Hiroshi Takasaki Etsuo Yonemochi Roman Messerschmid Masanori Ito Koichi Wada Katsuhide Terada
29847984
Moisture Activated Dry Granulation Traditional Granulation Techniques
In the pharmaceutical industry, the three most common granulation processes for solid dosage form production are wet granulation, dry granulation (roller compaction) and direct blending. Yet, despite being well established techniques, each has its drawbacks. Moisture activated dry granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling, and offers an efficient, cost effective granulating process that does not require a drying step.
15417669
PROCESS DEVELOPMENT AND OPTIMIZATION FOR MOISTURE ACTIVATED DRY GRANULATION METHOD FOR LOSARTAN POTASSIUM TABLETS
Objective: The present study deals with the formulation and process development of Losartan potassium tablets by moisture activated dry granulation (MADG) process and optimization of granulating fluid uptake concentration. Methods: Losartan potassium was selected as a model drug and Micro crystalline cellulose (MCC) as a binder. Losartan potassium tablets prepared by MADG process were found to be a simple, clean and robust process. Losartan potassium tablets were manufactured for the Seven batches F I to F VII using different concentrations of granulating fluid, keeping the total weight (75 mg) of the tablet constant in all the formulations. Results: The results from the evaluation of the effects of the granulating binder level, binder type suggest that the MADG process is robust and creates granulation with good physical properties and finished products with satisfactory quality attributes. The process is applicable for accomplishing most of the granulation need for solid dosage form development as practiced in the pharmaceutical industry. It is essentially a onestep granulation process. It is also an economical, energy saving and efficient manufacturing process. Conclusion: The losartan potassium tablets prepared by MADG process had advantages such as short manufacturing time and process variables when compared with convention wet granulation process.
Basu Venkateswara Reddy K Navaneetha K Venkata Narapa Reddy
138201852
PROCESS DEVELOPMENT AND OPTIMIZATION FOR MOISTURE ACTIVATED DRY GRANULATION METHOD FOR LOSARTAN POTASSIUM TABLETS Original Article
Objective: The present study deals with the formulation and process development of Losartan potassium tablets by moisture activated dry granulation (MADG) process and optimization of granulating fluid uptake concentration. Methods: Losartan potassium was selected as a model drug and Micro crystalline cellulose (MCC) as a binder. Losartan potassium tablets prepared by MADG process were found to be a simple, clean and robust process. Losartan potassium tablets were manufactured for the Seven batches F I to F VII using different concentrations of granulating fluid, keeping the total weight (75 mg) of the tablet constant in all the formulations. Results: The results from the evaluation of the effects of the granulating binder level, binder type suggest that the MADG process is robust and creates granulation with good physical properties and finished products with satisfactory quality attributes. The process is applicable for accomplishing most of the granulation need for solid dosage form development as practiced in the pharmaceutical industry. It is essentially a onestep granulation process. It is also an economical, energy saving and efficient manufacturing process. Conclusion: The losartan potassium tablets prepared by MADG process had advantages such as short manufacturing time and process variables when compared with convention wet granulation process.
Basu Venkateswara Reddy K Navaneetha K Venkata Narapa Reddy
138141046
OPTIMIZATION OF THE MOISTURE ACTIVATED DRY GRANULATION PROCESS FOR NAPROXEN 500 MG TABLETS USING DESIGN SPACE CONCEPT
An attempt is made to adopt and optimize the Moisture Activated Dry Granulation (MADG) process for Naproxen (NPX) 500 mg tablets. The level of NPX, Lactose and fluid uptake to be used in the agglomeration stage was optimized using the 23 design of experiments. The granules characteristics were determined, tablets were compressed at two hardness levels and the drug release at 2 minutes, 15 minutes and 30 minutes were considered as measurable parameters. Based on the data, the design space for NPX, Lactose and fluid uptake for agglomeration stage was defined. It was observed that the level of NPX in the agglomeration stage is critical for the product to pass the dissolution test.
S Sumalatha