Grades Of HPMC Research Articles

Formulation and Evaluation of Floating Tablets Using Natural Polymer.

Gastro-retentive effervescent floating tablets containing quetiapine fumarate (QP) are available using different viscosity grades of HPMC (HPMC K4M, HPMC K15M, and HPMC K100M) and TD made by the direct compression technique.The outcomes of the pre-compression parameters indicate that the powder mix of the formulations of both drugs has shown good micromeritic properties. Every tablet formulation that was made had the same amount of drug in it. The low standard deviation results imply that the drugs are distributed uniformly throughout the matrices.Drug compatibility with excipients is demonstrated by DSC and FTIR testing. It was discovered that the floating lag time was influenced by the concentration of citric acid and sodium bicarbonate. All the formulations (QP1 to QP17) floated for more than 24 hours, while the QP formulations remained buoyant for more than 12 hours. Accordingly, the present study’s results suggest that the QP floating system has a promising future as a substitute for the corresponding conventional dosage form.

Formulation Development of Non-effervescent Floating Pellets of Dried Ferrous Sulphate by Extrusion- Spheronization Technique

Dried Ferrous Sulphate is commonly used as iron salt for the treatment of iron deficiency by oral route, but conventional products face the problems of poor bioavailability due to its carrier-mediated absorption in an upper gastrointestinal region with a lower residence time at the absorption site and gastrointestinal side effects due to immediate release of the entire dose of an irritant drug which requires higher dosage frequency and prolonged duration of treatment to replenish deficient iron. Gastroretentive floating pellets of Dried Ferrous Sulphate would overcome these problems and to develop them using extrusion-spheronization, various grades of HPMC, ETHOCELTM 100cp along with Gelucire® 43/01 were tried in preliminary batches. Further optimization was done using Central Composite Design by selecting the different ratios of Gelucire® 43/01 and ETHOCELTM 100cp to a drug as formulation variables and spheronization time and speed as process variables, each at 3 levels. PVP K-30 as a binder and Isopropyl alcohol as a solvent were used. Pellets were characterized for average pellet size by sieving, roundness by microscopy, drug content, % drug release in vitro, and floating behaviour. Std run 3 with Gelucire® 43/01 (1.8:1) and ETHOCELTM 100cp (1.6:1), spheronized at 2000 RPM for 5 minutes was considered an optimized formulation which yielded an average pellet size of 868 µm ± 30, pellet roundness of 0.93± 0.02, immediate floating and sustained release for 12 hours in 0.1 N HCl dissolution medium and formulation with these characteristics could result into increased utilization of iron from the administered dose with reduced side effects.

DEVELOPMENT OF CONTROLLED RELEASE FORMULATIONS OF DEXLANSOPRAZOLE TO IMPROVE BIOAVAILABILITY

The present work was aimed to development of controlled release formulations of Dexlansoprazole to improve bioavailability. Dexlansoprazole is the proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step in acid production, thus reducing gastric acidity. Construction of calibration curve of Dexlansoprazole and to investigate the drug and polymer interaction studies by FTIR and DSC. To prepare the different controlled release formulations of Dexlansoprazole tablets with different polymers such as acrylic acid polymer such as Carbopol-974P, HPMC grades for prevalence HPMC-K4M, HPMC-K15M, HPMCK100M, Natural Polymers akin to Xanthan gum, Guar gum, Sodium Carboxy Methyl Cellulose, and Pectin by Direct Compression method. Evaluation of Dexlansoprazole pre compression parameters such as Bulk density, Tapped density, Hausner’s ratio, Carr’s index, Angle of repose. Evaluation of post-compression parameters of Dexlansoprazole controlled release tablets such as Weight variation, Hardness, Friability test, Thickness, Drug Content and In-vitro dissolution studies. Evaluation of in-vitro dissolution uniqueness of all the formulations of Dexlansoprazole by using USP dissolution apparatus type-II (paddle). To study the mechanism of drug dissolution by applying kinetic parameters. To perform the stability studies of optimized formulations of Dexlansoprazole as per ICH guidelines.

Flow behavior under shear cell analysis of two HMPC grades

A comparative analysis was conducted to examine the flow characteristics of two HPMC grades and their fractions. Excipients processing contains critical steps in the manufacturing of solid dosage forms and therefore it is essential to determine their flowability. Flow characterization was done using conventional and shear cell methods. After the division into different particles size, HPMC2910 showed an increase of the ffc for the fractions with the largest particle size and HPMC2208 showed an unprecedented result for the fraction with the smallest size. Thus, for this excipient, the best ffc was obtained with the fraction containing the smallest particles which surprisingly contradicted the literature (shape effect overlapped the size effect). It was also found for different fractions that the ffc increased with the increasing of the σ1, showing in some of them a decrease of the same from a certain σ1 value. Furthermore, caking was not observed in both cases.

Formulation and Evaluation of Propranolol Hydrochloride Sustained Release Matrix Tablets Using Different Grades of HPMC and MCC

Formulation and Evaluation of Propranolol Hydrochloride Sustained Release Matrix Tablets Using Different Grades of HPMC and MCC

Formulation and Evaluation of Mouth Dissolving Film of Imipramine HCL

The main objective of the present study outlines a systematic approach for Design and Evaluation of Fast Dissolving Oral Films of Imipramine HCl to enhance the therapeutic efficacy and provide rapid onset of action in patients suffering from depression Because of patient may have trouble in swallowing a tablet or capsules. Mouth dissolving film is the most advanced oral solid dosage form due to its flexibility and comfort in use. Mouth dissolving films are oral solid dosage form that disintegrate and dissolve within a minute when placed in mouth without taking water or chewing. This dosage form allows the medication to bypass the first pass metabolism so bioavailability of medication may be improved. Fast dissolving Oral film of Imipramine Hydrochloride was formulated by using solvent casting method with different concentrations of HPMC-E3. Film forming property of various grades of HPMC was investigated based on preliminary characteristics of various batches of FDOFs.

Formulation and evaluation of ranitidine floating tablet

The aim of present investigation is to formulate floating tablet to increase duration of action of ranitidine. Floating tablet of ranitidine has long duration of action as compare to its sustained release formulation, Floating tablet has double duration of action than sustained release formulation. Floating tablet is developed by using various polymers like HPMC (15000) and few grades of carbopol, citric acid and sodium bicarbonate were added for effervescence. Tablets were prepared by wet granulation technique by using single operation punch machine in different formulation with polymers, also included testing of some physical parameters like swelling index , hardness and weight variations. In vitro buoyancy evaluation was carried-out and in vitro release of drug was also performed. Increase in quantity of effervescence did not affect buoyancy while facilitating the release of drug. In-Vitro drug release increased when increased quantity of polymers like HPMC and carbopol.

Formulation and Evaluation of Pravastatin Sodium Rapid Dissolving Films Using Various Hydrophilic Polymers

The current availability of a variety of novel oral administration technologies has enabled more effective pharmacokinetic and physicochemical investigations along with improved patient compliance. Typical solid-dosage formulations were replaced with rapid-dissolving films. An oral film dosage form that dissolves or disintegrates quickly in the mouth without the need for water is referred to as an "oral rapid dissolving film." The main objective of this study was to use the solvent casting method to explore rapid dissolving films of Pravastatin sodium using certain hydrophilic polymers, such as various grades of HPMC, PVA, and Ocimum basilicum mucilage powder. Various evaluation parameters were performed to the prepared films, including appearance, weight variation, thickness, folding endurance, moisture uptake, content homogeneity, and an in vitro disintegration and dissolution test. For stability testing, the optimized formulation was kept. The FTIR data revealed that there was no incompatibility between the medication and the polymers, and that all of the parameters were within the acceptable limits. FP9 (PVA 0.5%, OB 1.5 %) disintegrated the fastest of all the formulations, and the films remained stable. As a result, it may be stated that the Pravastatin sodium rapid dissolving films are possibly effective in treatment of hyperlipediemia with a rapid onset of action.

Formulation and Evaluation of Controlled Release Matrix Tablets of Cefixime Trihydrate

Abstract: The main objective of the present work was to develop sustained release matrix tablets of Cefixime Trihydrate were prepared by direct compression techniques and evaluates the effect of formulation variables such as lubricant, binder, polymer content and viscosity grades of HPMC on the behavior of Cefixime Trihydrate release. The prepared tablets were evaluated for various physico-chemical parameters. In vitro release profile was check to evaluate the sustained release matrix tablet of Cefixime Trihydrate. The drug release from the optimized formulation was found to follow zero order kinetics. Thus the phenomenon of drug release showed that the release of optimized formulation is controlled by diffusion. Administration of Cefixime Trihydrate in a sustained release dosage would be more desirable for bacterial infections effects by maintaining the plasma concentrations of the drug well above the therapeutic concentration. From In vitro dissolution profile, Formulation S3 was prepared with Hydroxypropyl methylcellulose (K15M) combination where drug release was about 99.14% at the end of 24 hrs and followed zero order with non-Fickian diffusion method. It is selected as the best formulation.

Formulation and evaluation of in situ ophthalmic gel of loteprednol etabonate

The aim of present study was to prepared ocular in-situ gel to increase the residence time of drug in cornea for improvement of ocular bioavailability of drug. In situ gel of Loteprednol etabonate was prepared by using carobopol 940 and different grades of HPMC in different ratios by pH triggered method. The prepared in situ gels were evaluated for pH, drug content, viscosity, gelling time, gelling strength spreadability and sterility testing. In vitro drug release study was carried by using diffusion cell with dialysis membrane. The drug content and pH of the formulation were found to be satisfactory. The gelling strength was found to be in the range of 34 seconds to 91 seconds. The viscosity and spredability of the formulations were found to be satisfactory. Formulation F5 containing 0.3 % carobopol 940 and 0.6 % HPMC K4M showed highest drug release of 80.30 %. The developed formulations showed sustained release of drug up to 8 hrs. From in-vitro drug release studies, it could be concluded that the developed in-situ gelling systems were thus a better alternative to conventional eye drops.

Effect of Polymer Species on Maximum Aqueous Phase Supersaturation Revealed by Quantitative Nuclear Magnetic Resonance Spectroscopy.

The polymer used in an amorphous solid dispersion (ASD) formulation impacts the maximum achievable drug supersaturation. Herein, the effect of dissolved polymer on drug concentration in the aqueous phase when a drug-rich phase was generated by liquid-liquid phase separation (LLPS) was investigated for different polymers at various concentrations of drug and polymer. Solution nuclear magnetic resonance (NMR) spectroscopy revealed that polyvinylpyrrolidone (PVP), polyvinylpyrrolidone/vinyl acetate (PVP-VA), and hypromellose (HPMC) distributed into the ibuprofen (IBP)-rich phase formed by LLPS when the amorphous solubility of IBP was exceeded. The amount of polymer in the drug-rich phase increased for higher-molecular-weight grades of PVP and HPMC. Moreover, PVP-VA showed a greater extent of distribution into the IBP-rich phase compared to PVP, and this is attributed to its reduced hydrophilicity resulting from the incorporation of vinyl acetate monomers. Direct quantification by NMR measurements indicated that the IBP concentration in the aqueous phase decreased as the amount of polymer in the IBP-rich phase increased. This can be attributed to a reduction of the chemical potential of IBP in the IBP-rich phase. The reduction in dissolved IBP concentration was greater for the IBP/PVP-VA system compared to the IBP/HPMC system, as a result of more extensive drug-polymer interactions in the former system. The present study highlights the impact of polymer selection on the attainable supersaturation of the drug and the factors that need to be considered in the formulation of ASDs to obtain optimized in vivo performance.

Formulation and Evaluation of Bi-Layer Tablets of Ketorolac Tromethamine

The objective of the present study was to develop and evaluate bi-layer tablets of Ketorolac tromethamine, a nonsteroidal antiinflammatory drug with short half-life, that are characterized by initial burst drug release in the stomach and comply with the release requirements of sustained-release products. Each of the proposed bi-layer tablets is composed of an immediate-release layer and a sustained-release layer, anticipating rapid drug release that starts in the stomach to rapidly alleviate the symptoms and continues in the intestine to maintain protracted analgesic effect. Gastro retentive Bi-Layer tablets of Ketorolac Tromethamine were prepared by using hydrophilic polymers with direct compression on floating – matrix technology and evaluated. Ketorolac tromethamine is freely soluble in water, so it is suitable to develop it as gastro retentive bi-layer tablets using hydrophilic polymers. The developed formulation is equivalent to calculated theoretical drug profile in view of its in vitro release. Immediate release layer was prepared by using dry granulation method in which ac-di sol used as a disintigrant for immediate release of drug. Sustained release layer formulated by using HPMC as release retardant, two grades of HPMC that are HPMC K4M and HPMC K100M used to get sustained release profile for 24 hr. Various trial batches are taken to get desired release profile. Ketorolac tromethamine release from the developed floating formulation followed Higuchi model and nonFickian diffusion is found to be the main mechanism of drug release. The manufacturing procedure was found to be reproducible and formulations were stable after one month of stability studies.
 Keywords: FTIR; Gastro retentive bilayer; ketorolac tromethamine; in vitro release; stability; higuchi.

FORMULATION AND EVALUATON OF FLOATING TABLET OF CEFPODOXIME PROXETIL

Ideal once daily floating drug delivery system should release the drug for 24 hours and float up to 24 hrs. Once daily floating matrix tablet of Cefpodoxime proxetil should be release the drug for 24 hours to maintain the effective plasma level. All the formulations were prepared by using two different grades of HPMC (K100 and K4), cross povidone and MCC pH 101. HPMC is a matrix forming agent. All the formulations showed buoyancy lag time of less than 5 seconds regardless of concentration of HPMC K100 M, K4 and cross povidone. It may be due to the low density of tablet. The swelling index of HPMC K100 M was found to be higher than that of HPMC K4 M. This may be due to high molecular weight and high viscosity of HPMC K100 M. The formulation F1 containing low level of HPMC K100 M (75 mg) and low level of cross povidone (75 mg) showed higher burst release and maintained drug release up to 24 hours. The tablet was remained floated for 24 hours. High level of HPMC K100 M (F2, F3, F5,F6,) results in greater amount of gel being formed. This gel increases diffusion path length of the drug and hence release rate decreases. On the same line it formulation F5 and F8 should show relatively less drug release as high level of HPMC K100 M(100 mg & 125 mg respectively) is used in these formulations. But both the formulations released more than 97% drug within 24 hours. the formulations F10,F13,F14,F16,F17 released the drug within 20 hours. The formulation F11 which contains high amount of HPMC K4 M than F10 (100mg) and low level of cross povidone (75 mg) shows drug release up to 24 hours with sufficient floating duration. The formulation F15 and F18 contains high level of HPMC K4 M (125mg) and high level of cross povidone (100mg and 125mg) respectively. Both the formulations showed sustained drug release up to 24 hrs. EYWORDS: formulation, floating tablet, cefpodoxime proxetil

Formulation and Evaluation of Extended Release Matrix Tablets of Tenatoprazole Sodium using Synthetic Polymers

Extended release formulations are designed to release their medication in a controlled manner at a predetermined rate, duration and location to achieve and maintain optimum therapeutic blood levels of a drug. The present investigation is aimed to formulate the extended release matrix tablets of Tenatoprazole sodium with various grades of different polymers like Carbopol, HPMC and Eudragit grades. The tablets were prepared by wet granulation technique. The prepared ER Matrix tablets were evaluated for various physico chemical parameters. All the formulations resulted in acceptable Pharmacopoeia limits. In-vitro drug release studies (USP dissolution rate test apparatus II, 75 rpm, 37°C ±0.5°C) using 0.1N hydrochloric acid (1.2 PH ) for first 2 hrs and phosphate buffer (PH 6.8) as a dissolution medium (900ml) for the next 12 hrs. Among all the formulation F-5(drug: Carbopol-974P-NF in ratio of 1:1.5) shows better result upto 12 hours of the drug release was found to be 99.47±0.22 so it’s an Optimized formulation. Key words: Carbopol, ER Matrix, Eudragit, Methocel, Tenatoprazole sodium, Wet granulation.

Studies on Span based Soy-bigels with HPMC

Organogels owing to their lipophilic nature and better stability over other gel preparations may have a wide range of application but leaching of oily phase restricts their application. Use of hydrogel is limited by its stability problems and syneresis at atmospheric condition. Attempts to overcome such drawbacks can be overcome by combining both lipophilic organogel and hydrophilic hdydrogel phases in a single formulation, bigel. The present study deals with the development and evaluation of soy-bigel by mixing organogel of soybean oil (prepared with Span 40 or Span 60) and hydrogel of HPMCK4M or HPMCK15M in a definite ratio. Four batches of soy-bigels were prepared by mixing organogel with 18%w/v Span and 3% HPMC hydrogel. Formulations were examined for compatibility by FTIR spectroscopy, characterized for physical appearance, pH, rheological behavior, in vitro drug release pattern and thermal stability study. FTIR study confirmed compatibility between paracetamol and components of bigel. Soy-bigels were found to possess satisfactory organoleptic properties and applicability parameters and demonstrated pseudoplastic flow behavior. Better drug release was observed in soy-bigel prepared with Span 40 and HPMCK4M (OHP2) which followed Kormeyer-Peppas model with non-Fickian diffusion. Diffusion-controlled drug release gradually decreased in gels of matrix type developed with Span 60 and either grade of HPMC (OHS1 and OHS2). Soy-bigels prepared from Span 40 and either grades of HPMC demonstrated thermal stability on exposure to 5 freeze-thaw cycles. Thus, soy-bigels prepared from Span 40 and HPMCK4M exhibited satisfactory rheological property and improved drug release and can ideally be selected as a topical base for drug delivery.

Preparation, Physicochemical Evaluation and Characterization of Mucoadhesive Buccal Gels Impregnated with Benzydamine Hydrochloride for the Effective Treatment of Aphthous Stomatitis: Effect of Different Grades of HPMC Polymer on In vitro and Ex vivo Performance

Background: Drug delivery across the buccal mucosal epithelium membrane is one of the promising routes to treat various recurrent ailments of the oral cavity. Aphthous stomatitis is an inflammatory oro-mucosal disorder associated with mucous membranes of mouth, cheek, lips, tongue or gingival region. Benzydamine Hydrochloride was designated as a drug of choice by virtue of its anesthetic, antimicrobial, analgesic, anti-inflammatory and antibacterial action. The medication administration through the buccal route is very testing because of restricted absorption area, shorter residence time and movements of the target region. <p></p> Objective: To prepare mucoadhesive buccal gel of Benzydamine Hydrochloride and assess the effects of various HPMC polymer on in vitro and ex vivo performance with the assumption to extend the residence period and achieve maximum drug release in a sustained manner at the target region. <p></p> Methods: Mucoadhesive buccal gels were formulated by utilizing various HPMC grades that served as rate controlling and mucoadhesive polymer. A total of 24 preparations were formulated and subjected to physicochemical evaluation and characterization. <p></p> Results: It was found that the physicochemical parameters varied according to the polymer type and concentration used. Eight formulations were exposed to ex vivo study by virtue of maximum in vitro permeation and mucoadhesion properties. Because of higher ex vivo drug permeation and mucoadhesion, F24 was considered as the final optimized formulation. FTIR and DSC established compatibility between the drug and excipient. The amorphous nature of the drug within the optimized formulation was further unveiled by XRD study. <p></p> Conclusion: The developed buccal gel has a great prospective in contrast to marketed conventional preparation for treating aphthous stomatitis.

Plasticiser-Free 3D Printed Hydrophilic Matrices: Quantitative 3D Surface Texture, Mechanical, Swelling, Erosion, Drug Release and Pharmacokinetic Studies.

Hydroxypropyl methyl cellulose, HPMC, a hydrophilic polymer, is widely used for the development of extended release hydrophilic matrices and it is also considered as a good contender for the fabrication of 3D printing of matrix tablets. It is often combined with plasticisers to enable extrusion. The aim of the current project was to develop plasticizer-free 3D printed hydrophilic matrices using drug loaded filaments prepared via HME to achieve an in vitro (swelling, erosion and drug release) and in vivo (drug absorption) performance which is analogous to hydrophilic matrix tablets developed through conventional approaches. Additionally, the morphology of the printed tablets was studied using quantitative 3D surface texture studies and the porosity calculated. Filaments were produced successfully and used to produce matrix tablets with acceptable drug loading (95–105%), mechanical and surface texture properties regardless of the employed HPMC grade. The viscosity of HPMC had a discernible impact on the swelling, erosion, HPMC dissolution, drug release and pharmacokinetic findings. The highest viscosity grade (K100M) results in higher degree of swelling, decreased HPMC dissolution, low matrix erosion, decreased drug release and extended drug absorption profile. Overall, this study demonstrated that the drug loaded (glipizide) filaments and matrix tablets of medium to high viscosity grades of HPMC, without the aid of plasticisers, can be successfully prepared. Furthermore, the in vitro and in vivo studies have revealed the successful fabrication of extended release matrices.

Biopharmaceutical and Pharmacodynamic Characteri-stics of Telmisartan Oral Disintegrating Films


 This research work was aimed to develop the telmisartan fast dissolving films. Fast dissolving films allow rapid drug dissolution in the oral cavity and thereby bypass the first pass metabolism. Solid dispersions of telmisartan using natural polymers such as hupu gum (HG), guar gum (GG) and xanthan gum (XG) were prepared by kneading technique and the optimized solid dispersion was exploited in the development of rapidly dissolving film. Telmisartan films were prepared by solvent casting method using different grades of HPMC (E5, 50 cps and K4M). Six formulations (FT1-FT6) of telmisartan films were prepared and evaluated for their physical characteristics such as thickness, tensile strength, percentage elongation, weight variation, folding endurance, drug content uniformity and surface pH and gave satisfactory results. The compatibility of the drug in the formulation was confirmed by FTIR and DSC studies. The formulations were subjected to disintegration, in vitro drug release and pharmacodynamic studies on spontaneous hypertensive rats (SHR). Amongst the formulations of FT1-FT6, FT6 was found as best formulation which contains HPMC E5 and telmisartan solid dispersion with guar gum at weight ratio of 1:2 and showed excellent film forming characteristics such as disintegration time at 42 sec and percentage drug release 97.98% within 10 minutes. The optimized film formulation (FT6) showed excellent stability over 45 days when stored at 40°C/60% RH. The pharmacodynamic study in SHR proved that fast dissolving films of telmisartan produced a faster onset of action.

Design, Development and In vitro/Ex vivo Evaluation of Mucoadhesive Buccal Film of Benzydamine Hydrochloride for the Effective Treatment of Aphthous Stomatitis.

During the recent two decades, the development of mucoadhesive drug delivery system has been gained tremendous importance to cure many recurrent diseases of the oral cavity. The drug delivery through the buccal route is quite challenging due to limited absorption area, movements of the target region and regular flow of saliva lead to the sub-therapeutic drug level in the buccal region. The aim is to develop unidirectional release mucoadhesive buccal film for the mucosal delivery of Benzydamine Hydrochloride (WO2016126217Al, EP0812193B1) and evaluate the effects of a different grade of HPMC polymer (US5980942A) with the presumption to prolong the residence time and therapeutic effectiveness at the target site. Mucoadhesive buccal films were prepared by solvent casting evaporation method by employing different grades of HPMC as mucoadhesive and rate controlling polymer. Total twenty-four formulations were developed using ethyl cellulose as a backing layer. The prepared films were subjected to various physicochemical parameters. The physicochemical parameters were found to be varied according to the type and concentration of polymer used. On the basis of in vitro drug release, desired ex-vivo mucoadhesive time, mucoadhesive force the formulations F4, F9, F14 and F19 were subjected to ex vivo drug permeation study. The F14 film containing 1% w/v of HPMC K50M was considered optimized final formulation due to higher ex vivo drug permeation. Drug-excipient compatibility was confirmed by FTIR and DSC. XRD of final formulation revealed the amorphous nature of drug. SEM indicated the perfect binding between backing and adhesive layer. The developed mucoadhesive buccal film having adequate physicochemical properties was capable to provide prolonged residence time and sustained delivery as compared to existing conventional therapies.

Preparation and Characterization of Danazol Nanoparticles for Dissolution Improvement

Danazol is a synthetic steroid used for endometriosis treatment, haslow bioavailability as it is practically insoluble in water. This study has been carried out to prepare and characterize danazol nanoparticles by nanoprecipitation method at a different polymer to drug ratios of 0.5:1,1:1,2:1 and 3:1 using different polymers of CMC-30 and various grades of HPMC and PVP,as stabilizers. Variables that might affect the particle size as polymer type,polymer to drug ratio,temperature of precipitation,addition rate of danazol solution,volume ratio,time of stirring,concentrationof drug,have been investigated. The particle size of the prepared formulas has been in the nano-sized except those using CMC and the best formula has beenF20 at a polymer to drug ratio of0.5:1 which has given the smallest particle sizeof 33nm.The investigations of the drug–stabilizer compatibility havebeen studied by FTIR and DSC,crystalline state by XRD,size,and shape of nanoparticles by FESEM and the results showed that there has been no interaction between the danazol and stabilizer and there has been a partial conversion of danazol from crystalline to an amorphous state with a size below 100nm. Most of the studied factors havebeen found affect the particle size of the nanoparticles.The Entrapment efficiency has been (91.3% ± 0.4) in the (F20). The solubility study revealed that 6.75,4.97 and 5.1 folds increased of solubility of danazol for nanoparticles than that for raw in distilled water,0.1N HCl and in phosphate buffer of pH 6.8.The simple capsule has been prepared by incorporation of freeze-dried of F20 with lactose as a filler and the in vitro dissolution study has been conducted using 0.1N HCl (pH 1.2) with 2% w/v Brij-35,phosphate buffer solution(pH 6.8) with 2% w/v Brij-35as dissolution media. Within 30 minutes,100% of the danazol has been released from the nanoparticle capsule in both dissolution media compared to the raw and physical blend capsules as controls havebeen nearly complete in 120 minutes.One can conclude that Antisolvent method is an easy,efficient method to prepare danazol nanoparticles with an intense effect on solubility and faster in vitro dissolution rate than raw drug and its physical blend with stabilizer.