pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Legal and official requirement of container, packaging Dheeraj Saini
Here we discuss, the following subject topics
1. Official and legal requirements of container
2. Types of packing
3. Material used in packing or container
4. Label
5. Labelling techniques
Physical Properties of Pre-formulation.pptxRAHUL PAL
Preformulation studies provide a path for formulation development and drug product development in respect of drug form, adjuvants, composition, physical structure, and chemistry of drug molecules, facilitating pharmacokinetic and biopharmaceutical properties evaluation, adjustments, and their implementation.
Preformulation studies focus on the concepts of physicochemical properties which are vital for any new drug molecule and/or proteins/peptides. These properties not only affect their therapeutic efficacy but also the development process of their specific dosage form.
A comprehensive interpretation of pellets based on their definitions, advantages, disadvantages, mechanism of pellet formation and growth, pelletization techniques, formulation requirements, and the equipment system for manufacture of pellets.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Legal and official requirement of container, packaging Dheeraj Saini
Here we discuss, the following subject topics
1. Official and legal requirements of container
2. Types of packing
3. Material used in packing or container
4. Label
5. Labelling techniques
Physical Properties of Pre-formulation.pptxRAHUL PAL
Preformulation studies provide a path for formulation development and drug product development in respect of drug form, adjuvants, composition, physical structure, and chemistry of drug molecules, facilitating pharmacokinetic and biopharmaceutical properties evaluation, adjustments, and their implementation.
Preformulation studies focus on the concepts of physicochemical properties which are vital for any new drug molecule and/or proteins/peptides. These properties not only affect their therapeutic efficacy but also the development process of their specific dosage form.
A comprehensive interpretation of pellets based on their definitions, advantages, disadvantages, mechanism of pellet formation and growth, pelletization techniques, formulation requirements, and the equipment system for manufacture of pellets.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
3. CHEMICAL CHARACTERISTICS:
Oxidation:
It is very common pathway for drug degradation in both liquid and solid formulation.
Oxidation is the gain of oxygen, loss of hydrogen and/or loss of electrons
When iron reacts with oxygen it forms a chemical called rust. The iron is oxidized andthe
oxygen is reduced.
Oxidation occurs in two ways
Auto oxidation
Free radical oxidation
5. FACTORS AFFECTING OXIDATION PROCESS
1) Oxygen concentration
2) Light
3) Heavy metals particularly those having two or more valencestate
4) Hydrogen & HydroxylIon
5) Temperature
PREVENTION OF OXIDATION
1) Reducing oxygen content
2) Storage in a dark and cool condition
3) Addition of chelating agent (Eg. EDTA, Citric acid, Tartaric acid)
4) Adjustment of pH
5) Changing solvent (Eg. Aldehydes, ethers, Ketones, may influence free radical reaction)
6) Addition of an antioxidant or reducing agent (e.g. H2, CO, Zn etc.).
6. HYDROLYSIS
o It is the cleavage of chemical bonds by the addition of water.
o The reaction of water with another chemical compound to form two or more products,involving
ionization of the water molecule usually splitting the othercompound.
Examples include :
o the formation of acids or bases from dissolved ions.
When this attack is by a solvent other than water than it is known assolvolysis
7. PREVENTION OF HYDROLYSIS:
pH adjustment
o Formulate the drug solution close to its pH of optimum sability.
o Addition of water miscible solvent in formulation
o Optimum buffer concentration
Addition of surfactant
o Nonionic, cationic, and anionic surfactant stabilizes the drug against base catalysis
Salts and Esters Eg. Phosphate esters of clindamycine
o The solubility of pharmaceuticals undergoing ester hydrolysis can be reduced by forming less soluble salts.
o By use of complexing agent
8. RACEMIZATION
Racemization is the process in which one enantiomer of a compound, such as an L-amino acid,
converts to the other enantiomer.
The compound then alternates between each form while the ratio between the (+) and (–)groups
approaches 1:1, at which point it becomes optically inactive.
If the racemization results in a mixture where the enantiomers are present in equal quantities, the
resulting sample is described as racemeric or a racemate.
9. The inter-conversion from one isomer to another can leadto
o different pharmacokinetic properties (ADME) as wellas
o different pharmacological &
o toxicological effect.
Example: L-epinephrine is 15 to 20 times more active than D-form, while activity of
racemic mixture is just one half of theL-form.
It depends on
o temperature,
o solvent,
o catalyst &
o presence or absence of light
10. Biological significance:
• Many psychotropic drugs show differing activity or efficacy between isomers,
e.g. Amphetamine is often dispensed as racemic salts while the more active dextro-
amphetamine is reserved for severe indications;
• Another example is Methadone, of which one isomer has activity as an opioid agonist
and the other as an NMDA antagonist.
11. POLYMERIZATION
Polymerization is a process of reacting monomer molecules together in a chemical reaction
to form polymer chains or three-dimensionalnetworks.
It is a continuous reaction between molecules.
More than one monomer reacts to form apolymer.
Eg. Darkening of glucose solution is due to polymerization of breakdown product [5-
(hydroxyl methyl) furfural.(a colorless liquid used in synthetic resin manufacture).
Eg. Shellac on aging undergoes polymerization & hence prolongs disintegration time&
dissolution time.