This document discusses spherical crystallization, which is a particle engineering technique that transforms drug crystals into spherical shapes. It has several advantages over traditional manufacturing like reduced processing time and equipment needs. The document outlines the basic materials and methods used, including solvents, polymers, and factors that affect the process. Common evaluation tests and applications are also mentioned, along with references for further reading.
Download PPT by clicking on following link
http://pharmastuff.blogspot.com/2018/07/spherical-crystallization-ppt.html
Spherical crystallization is a particle design technique, by which crystallization and agglomeration can be carried out simultaneously in one step.
Improves flowability and compressibility.
Crystalline forms of a drug to be converted into different polymorphic form having better bioavailability.
For masking of the bitter taste of drug.
General guide lines for the spherical agglomeration of drugs
Chow et al postulated some general guide lines for the spherical agglomeration of drugs
• For compounds that are water soluble, a water-immiscible organic solvent is used as the external medium and salt solutions of high concentration without common ions can be used as the bridging liquid.
• For compounds that are soluble in one or more organic solvents water is employed as the external phase and a water-immiscible organic solvent as the bridging liquid.
For compounds that are only soluble in water-miscible organic solvents a saturated aqueous solution of the compound can serve as the external phase and an organic solvent mixture as the bridging solvent.
• For compounds that are insoluble in water or any organic solvents a water-immiscible organic solvent can act as the external phase and a 20% calcium chloride solution as the bridging liquid. In addition, a binding agent such as PVP or PEG is required for agglomeration since the powders are not sufficiently soluble in the bridging liquids to allow binding through recrystallization and fusion.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Download PPT by clicking on following link
http://pharmastuff.blogspot.com/2018/07/spherical-crystallization-ppt.html
Spherical crystallization is a particle design technique, by which crystallization and agglomeration can be carried out simultaneously in one step.
Improves flowability and compressibility.
Crystalline forms of a drug to be converted into different polymorphic form having better bioavailability.
For masking of the bitter taste of drug.
General guide lines for the spherical agglomeration of drugs
Chow et al postulated some general guide lines for the spherical agglomeration of drugs
• For compounds that are water soluble, a water-immiscible organic solvent is used as the external medium and salt solutions of high concentration without common ions can be used as the bridging liquid.
• For compounds that are soluble in one or more organic solvents water is employed as the external phase and a water-immiscible organic solvent as the bridging liquid.
For compounds that are only soluble in water-miscible organic solvents a saturated aqueous solution of the compound can serve as the external phase and an organic solvent mixture as the bridging solvent.
• For compounds that are insoluble in water or any organic solvents a water-immiscible organic solvent can act as the external phase and a 20% calcium chloride solution as the bridging liquid. In addition, a binding agent such as PVP or PEG is required for agglomeration since the powders are not sufficiently soluble in the bridging liquids to allow binding through recrystallization and fusion.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
It consists the details about the pharmaceutical formulations and development as well as new drug development.
It consists the different stages in clinical trials.
It have the details about new drug application process
ANDA
NDA
FDA APPROVAL
IND APPLICATION
CLINICAL TRIALS AND RESEARCH
New drug invention
UV Spectrophotometric Method Development and Validation for Quantitative Esti...Sagar Savale
UV Spectrophotometric Method Development and Validation for quantitative estimation of Miconazole nitrate
(MIC). U.V Spectrophotometric method have been widely employed in determination of individual components in
a mixture or fixed dose combination. Our aim is to develop spectroscopic method for estimation of the Miconazole
nitrate (MIC) in ternary mixture by using U.V spectrophotometry. The method was validated as per ICH
guidelines. The recovery studies confirmed the accuracy and precision of the method. It was successfully applied
for the analysis of the drug in bulk and could be effectively used for the routine analysis.
SOLID DISPERSION
Definition: The technology is the science of dispersing one or more active ingredients in an inert matrix in the solid stage.
Need of solid dispersion:
Increases Oral bioavailability of a drug
Increased dissolution rate.
Enhanced release of drugs from ointment.
Improved the solubility & stability.
The concept of solid dispersion was originally proposed by Sekiguchi & obi.
Increasing the dissolution, absorption & therapeutic efficacy of drugs in dosage forms.
Increasing solubility in water.
Improving the oral absorption and bioavailability of BCS Class II drugs.
Physics of tablet compression, mechanism of tablet
formation, bonding in tablets, the effect of compressional force on tablet properties, effect
of lubricants on tablet compression, binding, instrumented tablet machines and tooling,
problems associated with large scale manufacturing of tablets.
This document contains the mostly asked questions for the job interviews of drug regulatory affairs which will help the candidate ace the interview with ease
Thank me later for this :*)
Aquasomes are nanoparticulate carrier system but instead of being simple nanoparticles these are three layered self assembled structures, comprised of a solid phase nanocrystalline core coated with oligomeric film to which biochemically active molecules are adsorbed with or without modification.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
It consists the details about the pharmaceutical formulations and development as well as new drug development.
It consists the different stages in clinical trials.
It have the details about new drug application process
ANDA
NDA
FDA APPROVAL
IND APPLICATION
CLINICAL TRIALS AND RESEARCH
New drug invention
UV Spectrophotometric Method Development and Validation for Quantitative Esti...Sagar Savale
UV Spectrophotometric Method Development and Validation for quantitative estimation of Miconazole nitrate
(MIC). U.V Spectrophotometric method have been widely employed in determination of individual components in
a mixture or fixed dose combination. Our aim is to develop spectroscopic method for estimation of the Miconazole
nitrate (MIC) in ternary mixture by using U.V spectrophotometry. The method was validated as per ICH
guidelines. The recovery studies confirmed the accuracy and precision of the method. It was successfully applied
for the analysis of the drug in bulk and could be effectively used for the routine analysis.
SOLID DISPERSION
Definition: The technology is the science of dispersing one or more active ingredients in an inert matrix in the solid stage.
Need of solid dispersion:
Increases Oral bioavailability of a drug
Increased dissolution rate.
Enhanced release of drugs from ointment.
Improved the solubility & stability.
The concept of solid dispersion was originally proposed by Sekiguchi & obi.
Increasing the dissolution, absorption & therapeutic efficacy of drugs in dosage forms.
Increasing solubility in water.
Improving the oral absorption and bioavailability of BCS Class II drugs.
Physics of tablet compression, mechanism of tablet
formation, bonding in tablets, the effect of compressional force on tablet properties, effect
of lubricants on tablet compression, binding, instrumented tablet machines and tooling,
problems associated with large scale manufacturing of tablets.
This document contains the mostly asked questions for the job interviews of drug regulatory affairs which will help the candidate ace the interview with ease
Thank me later for this :*)
Aquasomes are nanoparticulate carrier system but instead of being simple nanoparticles these are three layered self assembled structures, comprised of a solid phase nanocrystalline core coated with oligomeric film to which biochemically active molecules are adsorbed with or without modification.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
This presentation is about the way polyethylene can crystallise both from solution and in the bulk. The presentation illustrates chain folded crystallisation and how bulk spherulite crystallisation forms from chain folded crystal lamella. The presentation also shows how flow can induce "shish kebab" fibrous crystals.
Extraction experiments for Zn(II) ions from aqueous phase by new laboratory prepared Azo
derivation as complex agent 2- [4-bromo-2,6-diethyl phenylazo] -4,5-diphenylimidazole(BDPI)shows the
optimum conditions for this extraction method was (pH= 8) (10 minutes) shaking time and 50μg
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solvents used but there is in effect for organic solvent structure on the extraction of Zn+2 ions and
distribution ratio (D) values. Stoichiometric studies demonstrated the more probable structure ion pair
complex extracted for Zn+2 was 1:1.
It is common for students to use kits without knowing exactly what the different solutions/buffers are doing or what are they composed of. This automate attitude is wrong, thus, a proper discussion over the ins and outs of DNA extraction kits is imperative. The Toxicologist Today gives a little help, if you know more help us by commenting.
Filtration maybe defined as a nonthermal mechanical process in which undissolved particulates or suspended solid particles are separated from a solid liquid mixture by passing through a porous fibrous or granular permeable known as Filtration.
Filtration and filters maybe classified in a number of ways
By driving Force
By Function
By filtration Mechanism
By operating Cycle
By nature of Solid
Spherical crystallization (SC) is a promising technique, which encompass the crystallization, agglomeration, and spheronization phenomenon in a single step. Initially, two methods, spherical agglomeration, and emulsion solvent diffusion, were suggested to get a desired result
The term solid dispersion refers to a group of solid products consisting of a hydrophilic matrix and a hydrophobic drug frequently prepared by fusion solvent method. The matrix can be amorphous or crystalline in nature .
Acetabularia Information For Class 9 .docxvaibhavrinwa19
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1. Presented by— Under the guidance of—
Pradeep Tiwari Mr. K. Mahalingan
Pharmaceutics Dept.
1
2. Introduction
Advantages
Materials and Methods
Factors affecting the process of SC
Evaluation
Application
References
2
3. Kawashima et al(1986) used the spherical
crystallization technique for size enlargement
of the drug in the field of pharmacy.
Spherical Agglomeration is the novel
particle engineering technique that can
transform directly the fine crystals produced in
the crystallization process into a spherical
shape of drug/s with or without exciepients
from good solvent and bridging liquid by
addition of a non solvent.
3
4. The traditional drug manufacturing
procedures (granulation) involves following
steps:-
Crystallization → filtration → drying →
formulated powders blending → granulation
→ drying → tabletting.
This is a slow and time consuming
process.
Where as in spherical crystallization the
process could be reduced to:-
Crystallization → filtration → drying →
dry blending → tabletting.
4
5. It means less equipment and space,
lower labour costs, less processing time, and
lower energy consumption in the direct
tabletting process.
5
6. 1. Micromeritic properties of the drug crystals
shall be drastically improved by inducing
spherical shape to the crystals.
2. Utilization of this process improves wettability
and dissolution rate of drugs.
3. This technique could be used for masking of
the bitter taste of drugs.
4. No dose dumping.
5. Stirring of drug and exciepients in liquid
medium ensures homogeneity of drug.
6
7. 1. Selection of the suitable solvents is tedious
process.
2. Maintenance of processing parameters
(temperature, agitation) is difficult.
7
8. I. Drug
II. Polymers
III. Good Solvents - which solubilize drug/s. It
should be volatile, immiscible with non
solvent.
IV. Non Solvents - which causes precipitation or
crystallization of drug/s.
V. Bridging liquids - which causes preferential
wetting of crystals/solids and forms liquid
bridges during process.
8
9. Various methods are available for
preparation of spherical crystals of Drugs
which are as follows-
1. Solvent Change Method (SC)
2. Quasi Emulsion Solvent Diffusion (QESD)
3. Ammonia Diffusion Method (AD)
4. Neutralization Method
9
10. Solvent change method involves
simultaneous crystallization and
agglomeration of two or more drugs from a
good solvent and bridging liquid by addition
of a non-solvent.
10
11. Good solvent + Drug
In poor solvent
Formation of crystals with addition
of bridging liquid(drop wise)
Continuous agitation
Precipitated crystals and aggregation with
bridging liquid
Spherical agglomerates
Enlarged spherical agglomerates
11
12. The Drawback of this system is that it
provide low yield because the drug shows
significant solubility in the crystallization
solvent due to co-solvency effect. This method
is not applicable for water insoluble drugs.
12
13. In this method affinity between the drug
and a good solvent is stronger than that of the
drug and poor solvent.
The emulsion is stabilized by the selection
of suitable polymer which is required for
proper crystallization.
13
14. Drug + Good solvent
Into poor solvent
Formation of Emulsion
Continuous agitation
Good solvent which act as a bridging liquid
diffuses out into poor solvent phase
Formation of Spherical agglomerates
Polymeric solution
Stabilized spherical agglomerates
14
15. In this technique ammonia-water system
is used as the good solvent and bad solvent is
selected depending upon the drug solubilittty
in that solvent which is usually acetone.
This technique usually meant for Amphoteric
drugs which cannot be agglomerated by
conventional procedures .
The whole process is completed in three stages:-
15
16. First, the drug dissolved in ammonia water
is precipitated while the droplets collect the
crystals (Figure I).
Simultaneously, ammonia in the
agglomerate diffuses to the outer organic
solvent (Figure II).
Its ability to act as a bridging liquid
weakens and subsequently spherical
agglomerates are formed (Figure III).
16
17. This technique involves the formation of
fine crystals by neutralization and
consequently their agglomeration by a bridging
liquid.
1. The drug was dissolved in alkaline solution and then
poured into an acidic solution containing polymers
and bridging liquid under constant agitation.
2. The drug crystals are precipitated out by
neutralization of the base with acid.
17
18. 3. Then the precipitated crystals were simultaneously
agglomerated with the incorporated polymer through
the wetting action of the bridging liquid.
18
19. 1. Temperature- Temperature has significant
influence on the shape, size and texture of the
agglomerates .The solubility of drug is affected by
the temperature change.
2. Mode and intensity of agitation-The stirring speed
must be optimized. High speed agitation is
necessary to disperse the bridging liquid through
the system. But in some cases increasing stirring
rate, may cause reduction in agglomerate
formation due to increased disruptive forces.
Higher stirring rates produces agglomerates that
are less porous and more resistant to mechanical
stress. 19
20. 3. Amount of bridging liquid- The spherical
agglomeration method has been applied to
plenty of drugs, and it has been observed that
the properties of spherical agglomerates were
very much sensitive to the amount of bridging
liquid.
4. Residence time- The time for which the
agglomerates remain suspended in reaction
mixture effect the agglomerates strength.
20
21. Shape and size of agglomerates.
Solubility
Angle of repose
Hausner’s ratio
Carr’s index.
Porosity
Mechanical properties like crushing strength
and friability.
21
22. To improve the flowability and compressibility.
For masking bitter taste of drug.
For increasing solubility and dissolution rate of
poorly soluble drug.
22
24. Gupta MM, Srivastava B, Sharma M, Arya V. Spherical
Crystallization: A tool of Particle Engineering for making
drug powder suitable for direct compression. . IJPR and
Development 2010; 1:1-4.
Mahanty S, Sruti J, NiranjanPatra Ch, Bhanoji Rao ME.
Particle Design of drugs by Spherical Crystallization
Techniques. IJPS and Nanotechnology 2010; 3:912-14.
Patil PB, etal . Spherical Agglomeration- Direct Tabletting
technique. IRJP 2011;2(11), 30-35.
Tiwari S and Verma P. Spherical crystallization- A novel
drug delivery system. IJPLS 2011;2(9), 1065-1068.
Prathipati S etal . Spherical crystallization : A method to
improve physicochemical properties. IJPSRR 2011;14, 60-63.
24