scholarly journals Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
C. O. Migoha ◽  
M. Ratansi ◽  
E. Kaale ◽  
G. Kagashe
Keyword(s):  
Visible Region ◽  
Active Pharmaceutical Ingredient ◽  
Test Time ◽  
Sieve Analysis ◽  
Formulation Development ◽  
Compressibility Index ◽  
Enteric Coated ◽  
Time Changes ◽  
Preformulation Studies ◽  
Tapped Density

Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient (API). Micromeritics properties: bulk density (BD) and tapped density (TD), compressibility index (Carr’s index), Hauser’s ratio (H), and sieve analysis were performed in order to determine the best excipients to be used in the formulation development of omeprazole magnesium enteric coated tablets. Results show that omeprazole magnesium has fair flow and compressibility properties (BD 0.4 g/mL, TD 0.485 g/mL, Carr’s index 17.5%, Hauser’s ratio 1.2, and sieve analysis time 5 minutes). There were no significant drug excipient interactions except change in colour in all three conditions in the mixture of omeprazole and aerosil 200. Moisture content loss on drying in all three conditions was not constant and the changes were attributed to surrounding environment during the test time. Changes in the absorption spectra were noted in the mixture of omeprazole and water aerosil only in the visible region of 350–2500 nm. Omeprazole magnesium alone and with all excipients showed no significant changes in omeprazole concentration for a 30-day period. Omeprazole magnesium formulation complies with USP standards with regards to the fineness, flowability, and compressibility of which other excipients can be used in the formulation.

scholarly journals TECHNOLOGICAL ASPECTS OF TABLETS CREATION BASED ON FLAMMULINA VELUTIPES BIOMASS DRY POWDER

2018 ◽  
pp. 14-18
Author(s):  
T. A. Butkevych ◽  
М. L. Syatynya ◽  
V. P. Popovych
Keyword(s):  
Bulk Density ◽  
Flammulina Velutipes ◽  
Average Weight ◽  
Sieve Analysis ◽  
Technological Properties ◽  
Dry Powder ◽  
Technological Parameters ◽  
Hausner Ratio ◽  
Compressibility Index ◽  
Tapped Density

The aim of the work. To study the pharmaco-technological properties of granulate and tablets based on Flammulina velutipes biomass dry powder, to develop the composition and technology of the medication. Materials and Methods. Research of granules and tablets pharmaco-technological properties (sieve analysis, bulk density, tapped density, compressibility index, Hausner ratio, flowability of tablet mass, average weight, resistance to crushing, friability and disintegration of tablets) was carried out in accordance to the requirements of State Pharmacopoeia of Ukraine 2nd edition. Results and Discussion. The determined pharmaco-technological parameters of the granulate indicate good values ​​of the bulk density, tapped density, compressibility index, Hausner ratio and flowability. An intermediate product undergoes a tabletting process to produce a qualitative finished product of satisfactory appearance (plain, cylindrical tablets with a facet, yellowish-white color with brown inclusions, with a height of 4 mm, and diameter of 10 mm), a constant average mass (1.0 g), and strength (68 N). Conclusions. The pharmaco-technological properties of tablet mass (granulate) and Flammulina velutipes biomass dry powder tablets (sieve analysis, bulk density, tapped density, compressibility index, Hausner ratio, flowability, average weight, resistance to crushing, friability and disintegration) were studied. The composition and technology of Flammulina velutipes biomass dry powder tablets have been developed, pharmaco-technological parameters of their quality have been studied, technological block diagram of industrial production has been developed.

Formulation and invitro evaluation of delayed release multiple unit pellets of Lansoprazole in capsules

2021 ◽  
pp. 2625-2630
Author(s):  
Suresh Kolli ◽  
K. Vijayasri ◽  
P.N. Murthy
Keyword(s):  
Acidic Environment ◽  
Drug Content ◽  
Delayed Release ◽  
Accelerated Stability ◽  
Ich Guidelines ◽  
Compressibility Index ◽  
Release Studies ◽  
Enteric Polymer ◽  
Multiple Unit ◽  
Tapped Density

The present research was aimed to formulate and evaluate Lansoprazole delayed release multiple unit pellets in capsules. Lansoprazole degrades in the acidic environment of the stomach. It is also unstable under conditions of high temperature and high humidity which leads to therapeutic inefficiency. Hence it is important to bypass the acidic pH of the stomach. Protection of drug from acidic environment is done by coating the drug with enteric polymer. In the present study, successive layers of drug layer, barrier layer and enteric layer was coated on the inert sugar spheres by using solution/suspension layering technique in Fluidized bed processor (FBP). The prepared drug layered and barrier layered pellets were evaluated for % yield. The prepared lubricated pellets were evaluated for flow properties i.e., bulk density, tapped density, compressibility index and hausner’s ratio. Lubricated pellets filled into size ‘1’ capsules and evaluated for drug content, drug content resisted in acid, invitro drug release studies and compared with the marketed product. The dissimilarity and similarity factors for the optimized and marketed formulations were found to be 84.29. Accelerated Stability Testing (AST) was performed as per the ICH guidelines at 40±5°C/75±5% RH for 6 months and found satisfactory.

scholarly journals Formulation of Furosemide Oral Disintegrating Tablets Using Natural and Synthetic Superdisintegrants by SeDeM Expert Design System

2019 ◽  
Vol 9 (6) ◽  
pp. 55-63 ◽  
Author(s):  
Mulchand A. Shende ◽  
Kajal D Chavan
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
In Vitro Dissolution ◽  
Design System ◽  
Direct Compression ◽  
Compression Technique ◽  
Drug Content ◽  
Weight Variation ◽  
Preformulation Studies ◽  
Natural And Synthetic

SeDeM design expert technique used to evaluate the risks of poor flow of pharmaceutical powders under preformulation studies which reveals direct compression suitability and prepare robust composition of active pharmaceutical ingredient (API) and excipient in tablets formulation. The purpose of this study was to develop oral disintegrating tablets of Furosemide using different concentration of natural and synthetic superdisintegrants by means of SeDeM design technique. Oral disintegrating tablets (ODT) of Furosemide were prepared by direct compression technique using isolated banana powder and croscarmellose sodium (Ac-di-sol) together with microcrystalline cellulose as superdisintegrants. SeDeM design was performed to check suitability and deficient of excipients and drug for optimized composition derived based on IPP value. These tablets were evaluated for hardness, friability, drug content, weight variation, wetting time and in-vitro dissolution. All the formulations showed low weight variation with dispersion time less than 173.5±0.70 seconds and rapid in-vitro dissolution. The drug content of all the formulations was within the acceptable limits. Lubricated blend composition of F4 found average radius value 5.24, 0.66 and 5.509 for IGC, IP and IPP respectively, compressed tablet shown good physical properties. The optimized formulation F4 showed good release profile with 99.25 percentage drug release compared to other trial batches. It was concluded that natural superdisintegrant (banana powder) showed better disintegrating property than synthetic super disintegrant (Ac-di-sol) in the formulations of ODTs. Keywords: Furosemide, Oral disintegrating tablets, SeDeM expert system, Superdisintegrants

EVALUATION OF TRAPA BISPINOSA STARCH AS AN ALTERNATIVE TABLET EXCIPIENT TO MAIZE STARCH: ASSESSMENT BY PREFORMULATION AND FORMULATION STUDIES

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (08) ◽  
pp. 27-32
Author(s):  
S Venkatesh ◽  
◽  
B. N Babu ◽  
K. Latha ◽  
R Alvala ◽  
...  
Keyword(s):  
Moisture Content ◽  
Sieve Analysis ◽  
Maize Starch ◽  
Compatibility Studies ◽  
Flow Properties ◽  
Pharmaceutical Excipient ◽  
Dry Granulation ◽  
Preformulation Studies

Starch isolated from Trapa bispinosa (Trapaceae) fruit was studied as an alternative pharmaceutical excipient to maize starch. T. bispinosa starch has been evaluated by series of tests as mentioned in Indian Pharmacopoeia before being used for evaluation. It was tested along with maize starch as an alternative excipient by performing battery of preformulation and formulation tests. Preformulation studies like sieve analysis, micrometry, flow properties, moisture content, swelling index and compatibility studies were done as per recommended procedures. The tablets were prepared by wet and dry granulation using paracetamol and aspirin respectively, with Trapa starch as binder, disintegrant, binder and disintegrant and tablets were evaluated. The results obtained for T. bispinosa starch were comparable with maize starch and the T. bispinosa starch can be used as a pharmaceutical excipient in tablets preparation.

scholarly journals An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1071
Author(s):  
Zsófia Németh ◽  
Edina Pallagi ◽  
Dorina Gabriella Dobó ◽  
Gábor Kozma ◽  
Zoltán Kónya ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Active Pharmaceutical Ingredient ◽  
Experimental Models ◽  
Phospholipid Content ◽  
Formulation Development ◽  
Critical Material ◽  
Critical Material Attributes ◽  
Critical Process Parameters ◽  
Saline Solutions ◽  
Phosphate Buffered Saline

Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an “intermediate” active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG2000), the type of the hydration media (saline or phosphate-buffered saline solutions) and the cryoprotectants (glucose, sorbitol or trehalose). The characterisation results (size, surface charge, thermodynamic behaviours, formed structure and bonds) of the prepared liposomes supported the outcomes of the updated RA. The findings can be used as a basis for a particular study with specified circumstances.

scholarly journals Solubility Enhancement of Diclofenac Using Solid Dispersions

2021 ◽  
Vol 5 (1) ◽  
pp. 1-6
Author(s):  
Mohd. Aamir Mirza ◽  
Keyword(s):  
Solid Dispersion ◽  
Solid Dispersions ◽  
Diclofenac Sodium ◽  
Active Pharmaceutical Ingredient ◽  
Solubility Enhancement ◽  
Solvent Evaporation ◽  
Limiting Factor ◽  
Formulation Development ◽  
Enhanced Solubility ◽  
Evaporation Technique

Background: The phenomenon which gives rise to a homogenous system, formed by the dissolution of solute in a solvent is known as solubility. Low solubility is the limiting factor in formulation development. Diclofenac being BCS class II drug have low aqueous solubility of 0.00401mg/ml. Amongst various solubility enhancement techniques, solid dispersion is the easiest one. Objective: Present work is primarily focused on the development of solid dispersions of diclofenac through solvent evaporation technique utilizing Eudragit E100 as a carrier. Methods: Solid dispersion consists of at least one active pharmaceutical ingredient as a carrier in solid state. Various methods for preparing solid dispersions includes melt extrusion, fusion lyophilization, spray drying, solvent evaporation, and super critical fluid (SCF) technology. Solvent evaporation technique is used among various solid dispersion methods. Conclusion: The enhanced solubility found to be 0.485mg/ml. The dissolution was performed using USP Type II apparatus was %CDR of pure drug and its solid dispersion in 8 hr were found out to be 45.14926% and 98.04758% respectively. Henceforth, solid dispersion technique results marked solubility enhancement of diclofenac sodium.

A Logical Approach to Development of Natamycin Loaded NLCs: Preformulation Studies, Formulation Development and In Vitro Characterization

2021 ◽  
pp. 6033-6040
Author(s):  
Ishwari Choudhary ◽  
Preeti K. Suresh
Keyword(s):  
Entrapment Efficiency ◽  
Formulation Development ◽  
Visible Spectroscopy ◽  
Scanning Calorimetry ◽  
Solubility Profile ◽  
In Vitro Characterization ◽  
Uv Visible ◽  
Preformulation Studies

This study was aimed at the development of natamycin loaded nano-structured lipid carriers (NLCs) and their characterization for physicochemical properties i.e., Fourier Transform Infrared (FTIR), UV-Visible spectroscopy, meting point, solubility profile and partition coefficient. FTIR and Differential Scanning Calorimetry (DSC) permit the characterization of the drug, excipients and binary mixture and thus assisted in predicting the compatibility of natamycin with other excipients. Lipid screening for formulation of NLCs were performed by their solubility and drug affinity studies. High homogenization and sonication method was employed for the development of natamycin loaded NLCs and it was characterized for vesicle size, zeta potential, % entrapment efficiency, viscosity, pH and percentage drug release up to 12 h.

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