This document summarizes factors that affect drug stability and degradation. It discusses physical degradation due to loss of volatile constituents or water, and chemical degradation through hydrolysis, oxidation, and other reactions. Temperature, solvent properties like ionic strength and dielectric constant, and acid-base catalysis can impact degradation rates. Specific examples of how each factor influences degradation are provided, and numerical problems related to drug stability are presented. The document was prepared by Vaibhavi Vinod Meshram, a 4th semester B.Pharm student at Gondia College of Pharmacy in India under the guidance of Rahul Choudhary.
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.
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.
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.
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli
III Semester.
UNIT-IV / Micromeritics
Solubility of Drugs (PHYSICAL PHARMACEUTICS-I)Rakesh Mishra
Solubility expressions, mechanisms of solute solvent interactions,solubility parameters, factors influencing
solubility of drugs, diffusion principles in biological systems, Raoult’s law, real solutions. Partially miscible
liquids(Phase equilibria, Phase rule, One , two and three component systems, ternary phase
diagram, Critical solution temperature and applications). Distribution law, its limitations and
applications
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.
Presentation describes on reasons to conduct stability studies, effect of physical and chemical drug decomposition, effect of light and temperature on drug decomposition and storage of drug
Decomposition and stabilization of pharmaceutical productsArshad Khan
Drug stability:Stabilization of medicinal agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in expiration dating of pharmaceutical dosage forms. Photolytic degradation and its prevention.
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli
B Pharm / 2nd Year ,III Semester.
UNIT-I / Colloidal dispersion's
PHYSICAL PHARMACEUTICS II COARSE DISPERSION VijayaKumarR28
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli.
As per PCI syllabus for B Pharm / 2nd Year ,III Semester.
UNIT-III / Coarse dispersion
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.
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli
III Semester.
UNIT-IV / Micromeritics
Solubility of Drugs (PHYSICAL PHARMACEUTICS-I)Rakesh Mishra
Solubility expressions, mechanisms of solute solvent interactions,solubility parameters, factors influencing
solubility of drugs, diffusion principles in biological systems, Raoult’s law, real solutions. Partially miscible
liquids(Phase equilibria, Phase rule, One , two and three component systems, ternary phase
diagram, Critical solution temperature and applications). Distribution law, its limitations and
applications
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.
Presentation describes on reasons to conduct stability studies, effect of physical and chemical drug decomposition, effect of light and temperature on drug decomposition and storage of drug
Decomposition and stabilization of pharmaceutical productsArshad Khan
Drug stability:Stabilization of medicinal agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in expiration dating of pharmaceutical dosage forms. Photolytic degradation and its prevention.
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli
B Pharm / 2nd Year ,III Semester.
UNIT-I / Colloidal dispersion's
PHYSICAL PHARMACEUTICS II COARSE DISPERSION VijayaKumarR28
R. VIJAYAKUMAR., M Pharm,
Research Scholar
department of Pharmaceutical Technology.
Anna university- BIT
Tiruchirappalli.
As per PCI syllabus for B Pharm / 2nd Year ,III Semester.
UNIT-III / Coarse dispersion
This slide contains the preformulation studies.It contains the various physicochemical properties that must be undergo to formulate the better absorption and stabiity of the different type of dosage form.This is ultimately used for the B Pharmacy final year students.Download the colourful ppt and enjoy the experience.
A brief presentation on the factors affecting bioavailability of drugs along with a quick overview on what is bioequivalence, clinical equivalence, therapeutic equivalence, chemical equivalence and pharmaceutical equivalence.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
Observation of Io’s Resurfacing via Plume Deposition Using Ground-based Adapt...Sérgio Sacani
Since volcanic activity was first discovered on Io from Voyager images in 1979, changes
on Io’s surface have been monitored from both spacecraft and ground-based telescopes.
Here, we present the highest spatial resolution images of Io ever obtained from a groundbased telescope. These images, acquired by the SHARK-VIS instrument on the Large
Binocular Telescope, show evidence of a major resurfacing event on Io’s trailing hemisphere. When compared to the most recent spacecraft images, the SHARK-VIS images
show that a plume deposit from a powerful eruption at Pillan Patera has covered part
of the long-lived Pele plume deposit. Although this type of resurfacing event may be common on Io, few have been detected due to the rarity of spacecraft visits and the previously low spatial resolution available from Earth-based telescopes. The SHARK-VIS instrument ushers in a new era of high resolution imaging of Io’s surface using adaptive
optics at visible wavelengths.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
The increased availability of biomedical data, particularly in the public domain, offers the opportunity to better understand human health and to develop effective therapeutics for a wide range of unmet medical needs. However, data scientists remain stymied by the fact that data remain hard to find and to productively reuse because data and their metadata i) are wholly inaccessible, ii) are in non-standard or incompatible representations, iii) do not conform to community standards, and iv) have unclear or highly restricted terms and conditions that preclude legitimate reuse. These limitations require a rethink on data can be made machine and AI-ready - the key motivation behind the FAIR Guiding Principles. Concurrently, while recent efforts have explored the use of deep learning to fuse disparate data into predictive models for a wide range of biomedical applications, these models often fail even when the correct answer is already known, and fail to explain individual predictions in terms that data scientists can appreciate. These limitations suggest that new methods to produce practical artificial intelligence are still needed.
In this talk, I will discuss our work in (1) building an integrative knowledge infrastructure to prepare FAIR and "AI-ready" data and services along with (2) neurosymbolic AI methods to improve the quality of predictions and to generate plausible explanations. Attention is given to standards, platforms, and methods to wrangle knowledge into simple, but effective semantic and latent representations, and to make these available into standards-compliant and discoverable interfaces that can be used in model building, validation, and explanation. Our work, and those of others in the field, creates a baseline for building trustworthy and easy to deploy AI models in biomedicine.
Bio
Dr. Michel Dumontier is the Distinguished Professor of Data Science at Maastricht University, founder and executive director of the Institute of Data Science, and co-founder of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles. His research explores socio-technological approaches for responsible discovery science, which includes collaborative multi-modal knowledge graphs, privacy-preserving distributed data mining, and AI methods for drug discovery and personalized medicine. His work is supported through the Dutch National Research Agenda, the Netherlands Organisation for Scientific Research, Horizon Europe, the European Open Science Cloud, the US National Institutes of Health, and a Marie-Curie Innovative Training Network. He is the editor-in-chief for the journal Data Science and is internationally recognized for his contributions in bioinformatics, biomedical informatics, and semantic technologies including ontologies and linked data.
insect taxonomy importance systematics and classification
DRUG STABILITY
1. BY,
VAIBHAVI VINOD MESHRAM
B.PHARM 4TH SEM
GONDIA COLLEGE OF
PHARMACY, GONDIA
DRUG STABILITY
GUIDED BY,
RAHUL CHOUDHARY SIR
ASS. PROFESSOR
GONDIA COLLEGE OF
PHARMACY,
GONDIA.
2. CONTENT
• DRUG STABILITY
• PHYSICAL DEGRADATION OF PHARAMCEUTICAL PRODUCTS
• CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUTS
• TEMPERATURE
• SOLVENT
• IONIC STRENGTH
• DIELECTRIC CONSTANT
• SPECIFIC AND GENARAL ACID BASE CATALYSES
• SIMPLE NUMERICAL PROBLEMS
3. DRUG STABILITY:-
Drug stability means the ability of pharmaceutical
doses form to maintain the physical, chemical,
therapeutics, and microbial properties during storage
and usage by the patient.
- It is measured by the rate of changes that takes
place in the pharmaceutical dosage form.
- Expiry date means that drug cannot be used after
this date because the concentration of drug is
decreased and become lower than the therapeutic
concentration.
4. PHYSICAL DEGRADATION OF
PHARMACEUTICAL PRODUCTS
• Loss of Volatile Constituents
• Loss of Water
• Absorption of Water
• Crystal Growth
• Polymorphism
• colour changes
6. TEMPERATURE:-
● High temperature accelerated oxidation, reduction and hydrolysis
reaction which lead to drug degradation.
● 3 types of storage temperature
- Room temperature:- upto 30/25°C
- Cold temperatures:- 2-3°C
- Freeze storage :- storage between -20 to -10°C
● The effect of temperature is given by Arrehenius equation:
7. Solvent:-
for a reaction,
A+B-------> [A...B]-->product
The qualitative relationship between the reaction rate constant and the
solubility of the reactants and the products in the given by the equation
8. IONIC STRENGTH:-
The effect of ionic strength of a solution of the degradation rate may be
expressed in the form of following equation.
An increase in the ionic strength of the solution would decrease the rate
of the reaction involving interaction between oppositely charged ion and
increase the rate of reaction between similarly charged ion.
9. DIELECTRIC CONSTANT:-
• The dielectric constant or relative permeability of solvent has
significant effect on the rate of reaction.
• If the reacting molecules are of opposite charge then it will result in
increase rate of reaction.
• If the ions of similar charge involve in the reaction it will decrease
rate of reaction.
10. SPECIFIC AND GENERAL ACID -BASE
CATALYSIS:-
1. In any drug solution when buffer is added then their is no change
with acid or base concentration, because their pH is fixed but when
the pH is change due to the change in the [H] and [OH] inside the
solution then this type of reaction is called as Specific Acid Base
Catalysis reaction.
1. The Acid Base catalysis in solution is not restricted to hydrogen or
hydroxyl ions only, but often undissociated acids or bases also
produce a catalytic effect on the reaction such reaction are called as
general acid and base catalyze reactions.
