AU2021106637A4 - Novel composition of fisetin nanosuspension and process thereof - Google Patents
Novel composition of fisetin nanosuspension and process thereof Download PDFInfo
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- AU2021106637A4 AU2021106637A4 AU2021106637A AU2021106637A AU2021106637A4 AU 2021106637 A4 AU2021106637 A4 AU 2021106637A4 AU 2021106637 A AU2021106637 A AU 2021106637A AU 2021106637 A AU2021106637 A AU 2021106637A AU 2021106637 A4 AU2021106637 A4 AU 2021106637A4
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- Prior art keywords
- fisetin
- nanosuspension
- novel
- sodium lauryl
- lauryl sulfate
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- XHEFDIBZLJXQHF-UHFFFAOYSA-N fisetin Chemical group C=1C(O)=CC=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 XHEFDIBZLJXQHF-UHFFFAOYSA-N 0.000 title claims abstract description 58
- 235000011990 fisetin Nutrition 0.000 title claims abstract description 29
- 238000000034 method Methods 0.000 title claims abstract description 17
- 239000006070 nanosuspension Substances 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims abstract description 13
- 230000008569 process Effects 0.000 title claims abstract description 7
- 239000003814 drug Substances 0.000 claims abstract description 12
- 229940079593 drug Drugs 0.000 claims abstract description 12
- 238000009472 formulation Methods 0.000 claims abstract description 9
- 238000003801 milling Methods 0.000 claims description 10
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 8
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 8
- 239000000725 suspension Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 239000007921 spray Substances 0.000 claims description 4
- 239000003381 stabilizer Substances 0.000 claims description 4
- 239000011324 bead Substances 0.000 claims description 3
- 238000000889 atomisation Methods 0.000 claims description 2
- 229920001983 poloxamer Polymers 0.000 claims description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 2
- 229920000136 polysorbate Polymers 0.000 claims description 2
- 229950008882 polysorbate Drugs 0.000 claims description 2
- 229920000053 polysorbate 80 Polymers 0.000 claims description 2
- 229940069328 povidone Drugs 0.000 claims description 2
- 229920006316 polyvinylpyrrolidine Polymers 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000000375 suspending agent Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 abstract description 8
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
- 238000000338 in vitro Methods 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000010276 construction Methods 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000010951 particle size reduction Methods 0.000 description 2
- 230000000144 pharmacologic effect Effects 0.000 description 2
- 241000196324 Embryophyta Species 0.000 description 1
- 206010024641 Listeriosis Diseases 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 241000220317 Rosa Species 0.000 description 1
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 208000037884 allergic airway inflammation Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000001093 anti-cancer Effects 0.000 description 1
- 230000001430 anti-depressive effect Effects 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 230000009918 complex formation Effects 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 239000002612 dispersion medium Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 150000002215 flavonoids Chemical class 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 239000012737 fresh medium Substances 0.000 description 1
- 230000000055 hyoplipidemic effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002105 nanoparticle Substances 0.000 description 1
- 230000002276 neurotropic effect Effects 0.000 description 1
- 239000011380 pervious concrete Substances 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 239000002047 solid lipid nanoparticle Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/5123—Organic compounds, e.g. fats, sugars
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/513—Organic macromolecular compounds; Dendrimers
- A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5192—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Biomedical Technology (AREA)
- Nanotechnology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
NOVEL COMPOSITION OF FISETIN NANOSUSPENSION AND PROCESS
THEREOF
The present invention describes to formulation of nanosuspension fisetin. The said
nanosuspension fisetin enhance solubility, dissolution and drug loading compared with
naive fisetin. The said nanosuspension fisetin also enhance the bioavailability.
7
Description
[01] The present invention discloses a novel nanoformulation and composition offisetin. BACKGROUND
[02] Fisetin is a plant derived flavonoid that possesses pharmacological activities like antioxidant, anti-infammatory, hypolipidemic, anti-adipocyte differentiation, inhibition of allergic airway inflammation, neurotropic activity, anti-cancer and anti-depressant.
[03] Despite having various pharmacological properties, fisetin possesses low aqueous solubility and oral bioavailability.
[04]For achieving fast and complete drug dissolution, nanosuspension has emerged as a very promising approach, with numerous advantages as compared to other available techniques used toovercome aforementioned issues such as transformation into soluble amorphous state or, polymorph, complex formation, solid lipid nanoparticles aswell assolid dispersion.
[051 China patent number CN103191099A, disclosed Application of fisetin in preparation of drug for resisting listeria infection. The said technique is a costly technique which cannot be used at larger scale.
[051 China patent number CN102442987A, disclosed fisetin extraction method. The said technique is a costly technique which cannot be used at larger scale.
[06] None of the prior arts reported the nanoformulation of fisetin. The said research work solves the problems as stated in the prior art.
[071 Before the present systems and methods, are described, it is to be understood that this application is not limited to the particular systems, and methodologies described, as there can bemultiple possible embodiments which are not expressly illustrated in the present disclosure. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present application. This summary is provided to introduce a device for laboratory testing of pervious concrete and the concepts are further described below in the detailed description. This summary is not intended to identify essential features of the claimed subject matter nor is it intended for use in limiting the scope of the claimed subject matter.
[08]Disclosed is a novel nanoformulation of fisetin.
[09] In one of the embodiments of the invention where enhance bioavailability andsolubility bypreparing nanoformulation of fisetin.
[0010] In another embodiment of the the invention the stability and robustness of a nanosuspension are mainly governed by various formulation and process variables.
[0011] In yet another embodiment of the invention commonly used steric stabilizer includes hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), povidone (PVP K-30), and pluronics (F68 and F127) whereas electrostatic stabilizer includes polysorbate (Tween 80), sodium lauryl sulfate (SLS). A novel nanosuspension composition is proposed withenhanced dissolution rate of fisetin.
[0012] The foregoing detailed description of embodiments is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, example constructions of the disclosure are shown in the present document; however, the disclosure is not limited to the specific methods and apparatus disclosed in the document and the drawings. [0013] The detailed description is given with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The same numbers are used throughout the drawings to refer like features and components.
[0014] Figure 1 results of dissolution studies of fisetin.
[0015] The foregoing detailed description of embodiments is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, example constructions of the disclosure are shown in the present document; however, the disclosure is not limited to the specific methods and apparatus disclosed in the document and the drawings. [0016] The detailed description is given with reference to the accompanying figures. Inthe figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The same numbers are used throughout the drawings to refer like features and components. The disclosed embodiments are mere exemplary of the disclosure, which may be embodied in various forms. Some embodiments of this disclosure, illustrating all its features, will now be discussed in detail.
Characterization of developed formulation Particle size measurement and Zeta potential
[0019] In one embodiment of the present invention particle size and zeta potential of the nanosuspension is checked by using Malvern Zetasizer ZS200. Each sample should be measuredat least three times. The average values are employed for the calculations of the response surfaces.
Percentage yield and drug content
[0020] In another embodiment of the present invention of the fisetin content is dissolving accurately weighed quantity of fisetin nanoparticles in methanol. The solution is filtered, diluted appropriately in the samples, and measured using HPLC at 362 nm to determine drug content. In vitro dissolution studies
[0021] In yet another embodiment of the present invention in vitro dissolution studies are carried out in 900 ml 0.05 M phosphate buffer (pH 7.5) at 37 0.5 °C at 50 rpm (paddle method, Lab India dissolution tester DS 8000, USP- II). Pure fisetin (5 mg) and its equivalent optimized batch of nanosuspensions are added to the dissolution medium and 5 mL of sample is withdrawn at 5, 10, 15, 30, 45 and 60 min, respectively and replaced with fresh media.
[0022] The solutions are filtered with Whatman filter paper (0.22 m) and subjected to HPLC to determine the dissolved drug at 362 nm.
EXAMPLE 1
Results and advantages
[0023] Chromatogram of fisetin was detected at wavelength of 362 nm. Retention time for fisetin was found to be 7.10 min (Fig.1). The percent drugloading was found to be 92.55 1.16 %. The mean droplet size and zeta potentialof nanosuspension were found to be 226.43 nm and -25.21 mV, respectively.
[0024] The in-vitro dissolution study revealed more than 90% drug release within first five minutes from the formulation and only 2.16% drug release from the unprocessed drug. This indicated about 41.67 folds increase in drug release (Fig 2). The obtained results successfully demonstrated the formulation ofsolid emulsion of fisetin.
EXMPLE 2
Nanosuspension preparation by top down media milling
[0025] Preparation of nanosuspension by media milling involves two main steps. The first one is uniform dispersion of drug and stabilizer in dispersion media and the second one is particle size reduction in milling chamber. The uniform dispersion of PPK (3.10 g), SLS (0.50 g) and PVP K30 (0.40 g) in water was prepared by using Heidoph mixer (Mode RZR2051 control, rose scientific Ltd., Alberta, Canada) operated at 500 rpm. This suspension was loaded in milling chamber of bead mill (Model: Lab Star 1, Netzsch mill, Germany) for particle size reduction. The milling media used for this study was 0.2-mm yttrium-stabilized zirconium beads. The milling operation was performed in a recirculation mode with the suspension fed at a rate of 100 mL/min. The beadmill was operated at specific speed and time as designed by the DoE. The temperature of suspension was controlled during milling by circulating cold water through the outer jacket. The nanosuspensions were dried using spray dryer (Spray Dryer Model SprayMate, JISL, Mumbai, India) under the following set of conditions: inlet temperature, 110 °C; outlet temperature,
55 °C; feed rate, 18 mlmin; and atomization pressure, 2 kg/cm 2 .
[0030] Even though specific steps are mentioned in the process of the disclosure, it will be known that many alterations and modifications can be made to the process without departing from the principles of the invention. It is to be distinctively understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
Claims (6)
- We claim: 1. A novel process for making nanoformulation of fisetin wherein the process is comprising ofa. Uniformly dispersing of PPK (3.10 g), sodium lauryl sulfate (0.50 g) and polyvinylpyrrolidone K30 (0.40 g) in water by using Heidolph mixer operated at 500 rpm.b. Loading suspension in milling chamber of bead mill.c. Performing milling operation in a recirculation mode with the suspension fed at a rate of 100 mL/min.d. Operating beadmill at specific speed and time as designed by the DoE.e. Setting temperature of suspension during milling by circulating cold water through the outer jacket.f Using spray dryer for drying nanosuspension.
- 2. The novel formulation as claim 1 wherein fisetin is selected from a group consisting of fisetin (3.10 g) sodium lauryl sulfate (0.50 g) and polyvinylpyrrolidone K30 (0.40 g) and water quantity sufficient.
- 3. The novel formulation as claim 1 wherein fisetin is selected from a group consisting of fisetin as active drug, Sodium Lauryl Sulfate as stabilizing agent and polyvinylpyrrolidone K30 as suspending agent and water as a solvent.
- 4. The novel formulation as claimed in claim 1 wherein fisetin soluble in surfactant such as hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), povidone (PVP K-30), and pluronics (F68 and F127) preferably polysorbate (Tween-80), sodium lauryl sulfate (SLS).
- 5. The novel nanosuspension of fisetin as claimed in claim 1 wherein spray dryer has used under the following set of conditions: inlet temperature, 110 °C; outlet temperature, 55 °C; feed rate, 18 m/min and atomization pressure, 2kg/cm2 .
- 6. The novel formulation of claim 1 wherein the nanosuspention of fisetin is a free flowing powder.Applicant: Lovely Professional University Sheet No: 1/1 2021106637
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021106637A AU2021106637A4 (en) | 2021-08-23 | 2021-08-23 | Novel composition of fisetin nanosuspension and process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021106637A AU2021106637A4 (en) | 2021-08-23 | 2021-08-23 | Novel composition of fisetin nanosuspension and process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2021106637A4 true AU2021106637A4 (en) | 2021-12-23 |
Family
ID=78958114
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021106637A Ceased AU2021106637A4 (en) | 2021-08-23 | 2021-08-23 | Novel composition of fisetin nanosuspension and process thereof |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2021106637A4 (en) |
-
2021
- 2021-08-23 AU AU2021106637A patent/AU2021106637A4/en not_active Ceased
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| FGI | Letters patent sealed or granted (innovation patent) | ||
| MK22 | Patent ceased section 143a(d), or expired - non payment of renewal fee or expiry |