Acids, Bases And Buffers Pharmaceutical Inorganic chemistry UNIT-II (Part-I)
Acids, Bases are defined by Four main theories,
1.Traditional theory / concept
2.Arrhenius theory
3.Bronsted and Lowry theory
4.Lewis theory
Importance of acids and bases in pharmacy
Buffers: Buffer action
Buffer capacity Buffers system
Types of Buffers : Generally buffers are of two types:
1. Acidic buffers
2. Basic buffers
There are some other buffer system:
3. Two salts acts as acid-base pair. Ex- Potassium hydrogen phosphate and potassium dihydrogen phosphate.
4. Amphoteric electrolyte. Ex- Solution of glycine.
5. Solution of strong acid and solution of strong base. Ex- Strong HCl with KCl Mechanism of Buffer action: Mechanism of Action of acidic buffers: Buffer equation-Henderson-Hasselbalch equation:
Standard Buffer Solutions Preparation of Buffer Solutions: Buffers in pharmaceutical systems or Application of buffer: Stability of buffers Buffered isotonic solution Types of Buffer Isotonic solution
1. Isotonic Solutions:
2. Hypertonic Solutions:
3. Hypotonic Solution:
Measurement of Tonicity: 1. Hemolytic method: 2. Cryoscopic method or depression of freezing point:
Methods of adjusting the tonicity:
Class I methods:
In this type, sodium chloride or other substances are added to the solution in sufficient quantity to make it isotonic. Then the preparation is brought to its final volume withan isotonic or a buffered isotonic diluting solution.
These methods are of two types:
Cryoscopic method
Sodium chloride equivalent method.
Class II methods:
In this type, water is added in sufficient quantity make the preparation isotonic. Then the preparation is brought to its volume with an isotonic or a buffered isotonic diluting solution.
These methods are of two types:
White-Vincent method
Sprowls method.
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistr...Ms. Pooja Bhandare
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistry UNIT-II (Part-II)
Electrolyte: Intracellular fluid
Interstitial fluid
Plasma (Vascular fluid)
Anionic electrolytes- HCO₃⁻, Cl⁻, SO₄²⁻, HPO₄²⁻
Cationic electrolytes- Na⁺, K⁺, Ca²⁺, Mg²⁺
Concentration of important Electrolytes:
Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt
(ORS), Physiological acid base balance.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
This slide contains the details from topic, "Dental Product", B.Pharm 1st Semester, Pharmaceutical Inorganic Chemistry.
Dental Product
Desensitizing Agent
Dental Caries
Dentifrices
Role of Fluoride
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistr...Ms. Pooja Bhandare
Major extra and intracellular electrolytes. Pharmaceutical Inorganic chemistry UNIT-II (Part-II)
Electrolyte: Intracellular fluid
Interstitial fluid
Plasma (Vascular fluid)
Anionic electrolytes- HCO₃⁻, Cl⁻, SO₄²⁻, HPO₄²⁻
Cationic electrolytes- Na⁺, K⁺, Ca²⁺, Mg²⁺
Concentration of important Electrolytes:
Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt
(ORS), Physiological acid base balance.
Pharmaceutical Inorganic chemistry UNIT-V Radiopharmaceutical.pptx
Isotopes Types of decay
Alpha rays, which could barely penetrate a piece of paper
Beta rays, which could penetrate 3 mm of aluminium
Gamma rays, which could penetrate several centimetres of lead
Units of Radioactivity:
Measurement of Radioactivity
The measurement of nuclear radiation and detection is an important aspect in the identification of type of radiations (, , ) and to assay the radionuclide emitting the radiation, suitable detectors are required. The radiations are identified on the basis of their properties.
e.g. Ionization effect is measured in Ionization Chamber, Proportional Counter and Geiger Muller Counter.
The scintillation effect of radiation is measured using scintillation detector and the photographic effect is measured by Autoradiography.
Gas Filled Detectors:
Ionization Chamber:
Proportional Counters:
Geiger-Muller Counter
Properties of α, β, γ radiations
Half –life of Radioelement
Sodium Iodide (I131)
Handling and Storage of Radioactive Material:
Storage of Radioactive Substances –
Precautions For Handling Radioactive Substances
Labelling of Radioactive Substances
Pharmaceutical Application Of Radioactive Substances
This slide contains the details from topic, "Dental Product", B.Pharm 1st Semester, Pharmaceutical Inorganic Chemistry.
Dental Product
Desensitizing Agent
Dental Caries
Dentifrices
Role of Fluoride
This is chapter No 3 of Pharmaceutical Chemistry - I for Diploma in Pharmacy (D. Pharmacy) Details notes for Diploma in Pharmacy (D.Pharmacy) Students.
Limt test Pharmaceutical Inorganic chemistry UNIT-I (Part-III) Limit Test.
Limit tests:- Factors affecting limit tests:
Specificity of the tests
Sensitivity
Control of personal errors (Analyst errors)
Test in which there is no visible reaction
Comparison methods
Quantitative determination
Limit test for Chloride: Principle, Procedure, observation and result.
Limit test for Sulphate: Principle, Procedure, observation and result
Limit test for Iron: Principle, Procedure, observation and result.
Limit test for Heavy metal: Principle, Procedure, observation and result.
Limit test for Lead: Principle, Procedure, observation and result.
Limit test for Arsenic: Principle, Gutzet test Procedure, detail in Gutzet Apparatus. observation and result.
Modifies Limit test for Chloride: Principle, Procedure, observation and result.
Modified Limit test for sulphate: Principle, Procedure, observation and result.
Dental product is a topic of Pharmaceutical Inorganic Chemistry,for B.Pharmacy First year students.
this ppt is presented with the aim to enable with students to easily grasp unfamiliar,unacquainted & seemingly complicated concepts of Pharmaceutical Inorganic Chemistry so that it helps them to kindle their interest in the subject.
Prepared by,
Ms. Megha M. Muley
Assistant Professor
Neutralization curves in acid base analytical titrations, indicators.nehla313
Neutralization curves in acid base analytical titrations, indicators,
strong acid strong base
weak acid strong bse
strong acid weak base
weak acid and weak base
Pharmacopoeias,Sources of Impurities in Medicinal agents and Limit testssaimuniswetha1
Today's Topic Pharmacopoeias, Sources of Impurities in Medicinal agents and Limit tests for Chlorides, Sulphates, Heavy Metals, Lead, Iron in Pharmaceutical Analysis subject for B.pharmacy 1st year as per JNTUA Syllabus...
This is chapter No 3 of Pharmaceutical Chemistry - I for Diploma in Pharmacy (D. Pharmacy) Details notes for Diploma in Pharmacy (D.Pharmacy) Students.
Limt test Pharmaceutical Inorganic chemistry UNIT-I (Part-III) Limit Test.
Limit tests:- Factors affecting limit tests:
Specificity of the tests
Sensitivity
Control of personal errors (Analyst errors)
Test in which there is no visible reaction
Comparison methods
Quantitative determination
Limit test for Chloride: Principle, Procedure, observation and result.
Limit test for Sulphate: Principle, Procedure, observation and result
Limit test for Iron: Principle, Procedure, observation and result.
Limit test for Heavy metal: Principle, Procedure, observation and result.
Limit test for Lead: Principle, Procedure, observation and result.
Limit test for Arsenic: Principle, Gutzet test Procedure, detail in Gutzet Apparatus. observation and result.
Modifies Limit test for Chloride: Principle, Procedure, observation and result.
Modified Limit test for sulphate: Principle, Procedure, observation and result.
Dental product is a topic of Pharmaceutical Inorganic Chemistry,for B.Pharmacy First year students.
this ppt is presented with the aim to enable with students to easily grasp unfamiliar,unacquainted & seemingly complicated concepts of Pharmaceutical Inorganic Chemistry so that it helps them to kindle their interest in the subject.
Prepared by,
Ms. Megha M. Muley
Assistant Professor
Neutralization curves in acid base analytical titrations, indicators.nehla313
Neutralization curves in acid base analytical titrations, indicators,
strong acid strong base
weak acid strong bse
strong acid weak base
weak acid and weak base
Pharmacopoeias,Sources of Impurities in Medicinal agents and Limit testssaimuniswetha1
Today's Topic Pharmacopoeias, Sources of Impurities in Medicinal agents and Limit tests for Chlorides, Sulphates, Heavy Metals, Lead, Iron in Pharmaceutical Analysis subject for B.pharmacy 1st year as per JNTUA Syllabus...
Acids bases and buffers
Pharmaceutical Inorganic Chemistry
Unit 2, Chapter 1
Arrhenius, Bronsted-Lowry and Lewis Concepts of Acids and bases,
Concept of pH, pOH, pKa, pKb
Concept of buffers, buffer solutions, buffer action, and buffer capacity,
Buffer equation
Buffers in pharmaceuticals
Buffered isotonic solutions
Measurement and adjustment of tonicity
Introduction/ Concept of acid and base, Importance of acids and bases in Pharmacy, storage condition. Official acids: Phosphoric acid (Conc/dil), HCl (Conc/dil), Boric acid. Official Bases: NaOH, KOH, Ca (OH)2, dil. and strong NH3, Na2CO3, Acidosis and Alkalosis.
Arrhenius concept of acids and bases, bronsted-lowry theory of acids and bases,amphoteric nature of water , characteristics of strong acids , characteristics of weak acids , characteristics of strong bases, characteristics of weak bases, conjugate acids, conjugate base,introduction on buffers , preparation of buffers, types of buffer, acidic buffer, basic buffer, how do buffers act, why doesn't the ph of buffers doesn't change , Handerson-Hasselbach equation, buffer capacity, pharmaceutical buffers, why maintainance of body ph is important, osmolarity of blood, isotonic, hypertonic and hypotonic solution, pharmaceutical buffer system,phosphate-buffered saline, methods to measure tonicity, hemolytic method, methods to adjust tonicity, cryoscopic method, NaCl equivalent method
Types and Sources of impurities.pptx Pharmaceutical Inorganic chemistry UNIT-...Ms. Pooja Bhandare
Types and Sources of impurities. Pharmaceutical Inorganic chemistry UNIT-I (Part-II) Impurities:
Impure Chemical Compound
Pure Chemical Compound.
Types of impurities: Organic Impurity, Inorganic impurity, Residual solvent, Sources of Impurities in Pharmaceuticals
The different sources of impurities in pharmaceuticals are listed below:
Raw material used in manufacture
Reagents used in manufacturing process
Method/ process used in manufacture or method of manufacturing
Chemical processes used in the manufacture
Atmospheric contamination during the manufacturing process
Intermediate products in the manufacturing process
Defects in the manufacturing process
Manufacturing hazards
Inadequate Storage conditions
Decomposition of the product during storage
Accidental substitution or deliberate adulteration with spurious or useless materials.
Test for purity: Pharmacopoeia prescribes the “Test for purity” for pharmaceutical substances to check their freedom from undesirable impurities.
Pharmacopoeia will decide and fix the limit of tolerance for these impurities.
For certain common impurities for which pharmacopoeia prescribes the test of purity are:
Colour, odour, taste
Physicochemical constants (Iodine value, saponification value, melting point, refractive index etc.)
Acidity, alkalinity, pH
Humidity (Estimation of moisture)
Cations and anions
Insoluble Constituent or Residue.
Ash, Water insoluble ash
Arsenic or lead
Loss on drying
Loss on ignition.
Effect of Impurities
Introduction of Inorganic Chemistry, History of Pharmacopoeia.pptxMs. Pooja Bhandare
Introduction of Inorganic Chemistry, History of Pharmacopoeia, Pharmaceutical Chemistry, Inorganic Chemistry:
IMPORTANTS OF INORGANIC CHEMISTRY, Introduction of Pharmacopoeia, Types of Pharmacopoeia, History of pharmacopoeia, HISTROY OF INDIAN PHARMACOPOEIA
Content of pharmacopoeia Introduction including general Notices
Monographs of the official drugs
Appendices
Polyploidy, mutation and hybridization with reference to medicinal plants. PH...Ms. Pooja Bhandare
Polyploidy, mutation and hybridization with reference to medicinal plants. PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-4
Polyploidy reference to medicinal plants.
Types Of Polyploidy
A. Euploidy
a.Autopolyploidy
b. Allopolyploidy
B. Aneuploidy
1. Causes Of Polyploidy
2. Non-disjunction in mitosis
3. Non-reduction in meiosis
4. Polyspermy
5. Endo-replication or Endo- reduplication.
Factors Promoting Polyploidy
1. Physical factor
2. Chemical factor
3. Biological factor
Physical factor:-
Temperature :- heat temperature & cold temperature
Centrifugation
X-rays
Gamma rays
Cosmic rays
Ionizing & non-ionizing radiations
UV-radiations
Chemical factor:-
Alkylating agents:- nitrogen & sulphur mustard
Acridines
Proflavins
Nitrous acid
Colchicines[6]
Colchicines (Poisonous alkaloids):-
Biological factor
Mode of reproduction
Mode of fertilization
Breeding system present (Hybridization)
Growth habit of the plant
Size of chromosomes
Application Of Polyploidy
Mutation breeding
Seedless fruits production
Bridge crossing
Ornamental & forage breeding
Disease resistance through aneuploidy
Industrial application of polyploidy
mutation reference to medicinal plants
Type of mutations:
1. Spontaneous and induced mutations.
2. Recessive and dominant mutations.
3. Somatic and germinal mutations.
4. Forward, back and suppressor mutation.
5. Chromosomal, genomic and point mutations
Application Of Mutation:
Hybridization reference to medicinal plants
The following steps are involved in hybridization of plant:
Choice Of Parents:.
Selfing Of Parents
Emasculation:.
Bagging:
Crossing Or Cross Pollination
Labelling
Collection Of Hybrid Seeds
Significance of Hybridization
PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-2.FACTORS AFFECTING CULTIVATION
1. Altitude
2.Temperature
3. Rainfall
4. Day Length and Day Light
5. Soil
6. Soil Fertility
7. Fertilizers and Manures
a) Chemical fertilizers
(b) Manures
(c) Biofertilizers
8. Pests and Pests Control
a. Microbes
b) Insects
C) Non insect pests
d) Weeds
9. Other Factors that Affect the Cultivated Plants
a. Air Pollution
b. Herbicide
Cultivation and collections of drugs of natural origin..pptxMs. Pooja Bhandare
PHARMACOGNOSY & Phytochemistry-I (BP405T)Unit-IIPart-1Cultivation and collections of drugs of natural origin.
Advantages of cultivation
Methods of Plant Propagation
1.Sexual method (seed propagation)
2. Asexual method
Methods of sowing the seeds
Broadcasting Dibbling Miscellaneous
Special treatment to seeds
Asexual method.
Asexual method of vegetative propagation consists of three types:
a) Natural methods of vegetative propagation.
b) Artificial methods of vegetative propagation.
c) Aseptic method of micropropagation (tissue-culture).
COLLECTION OF CRUDE DRUGS
HARVESTING OF CRUDE DRUGS
DRYING OF CRUDE DRUGS
(1) natural (sun drying) and (2) artificial
Artificial Drying
Drying by artificial means includes drying the drugs in
(a) an oven; i.e. tray-dryers;
(b) vacuum dryers and
(c) spray dryers.
GARBLING (DRESSING)
PACKING OF CRUDE DRUGS
STORAGE & PRESEVATION OF CRUDE DRUGS
Quality control of Drugs of Natural Origin. PHARMACognosy & Phytochemistry-I ...Ms. Pooja Bhandare
Quality control of Drugs of Natural Origin PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-3.
CONTENTS
Adulteration
Evaluation of adulteration
Morphological / Organoleptic evaluation
Microscopic evaluation
Quantitative evaluation
Physical evaluation
Chemical evaluation
Biological evaluation
Adulteration is of two types:
Indirect or Unintentional adulteration
Direct or Intentional adulteration
Intentional adulteration may be due to the following reasons
adulteration using manufactured substances
substitution using inferior commercial varieties
substitution using exhausted drugs
substitution of superficially similar inferior natural substance
adulteration using the vegetative part of the same plant
addition of toxic materials
adulteration of powders
addition of synthetic principles
Evaluation of Crude Drugs
1. ORGANOLEPTIC EVALUATION
2. MICROSCOPICAL EVALUATION
Stomatal index Vein-islet number
Veinlet termination number
Palisade ratio
Quantitative Microscopy (Lycopodium Spore Method)
3.CHEMICAL EVALUATION
4. Physical Evaluation
I. Solubility
II. Optical Rotation
III. Refractive Index
III. Specific Gravity
IV Viscosity
V. Melting Point
VI. Moisture Content
VII. Ultraviolet Light
VIII. Ash Values
Total ash
Acid-insoluble ash
The water-soluble ash
IX. Extractive Values
X. Foreign Organic Matters
5. BIOLOGICAL EVALUATION
Toxicity
Oxytocic activity
Microbiological assays
Classification of Crude Drugs. HARMACognosy & Phytochemistry-I (BP405T)Unit-I...Ms. Pooja Bhandare
Classification of Crude Drugs.PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-2.
A method of classification should be:
a) simple,
b) easy to use, and
c) free from confusion and ambiguities.
TYPES OF CLASSIFICATION.
1.Alphabetical classification
2.Taxonomical classification
3.Morphological classification
4.Pharmacological classification
5.Chemical classification
6.Chemotaxonomical classification
7. Serotaxanomical Classification
Animal Cell Culture: Growth of animal cells in culture. PHARMACEUTICAL MICROB...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-4
Animal Cell Culture: Growth of animal cells in culture.
Introduction: Histroy, The culture media used for animal cell culture are classified as,
Natural, Artificial, Synthesized
Natural Culture Media:
a. Blood Plasma:
b. Blood Serum:
c. Tissue Extracts:
Artificial Media
Some common examples of artificial media are,
Minimal Essential Medium (MEM),
CMRL 1066,
RPMI 1640.
Synthetic media re classified as,
Serum Containing Media.
Serum Free Media.
a. Serum Containing Media:
b. Serum Free Media:
Physicochemical Parameters needed for growth animal cell culture:
General procedure for cell Culture.
Isolation of the tissue:
Disaggregation of the Tissue:
Mechanical disaggregation
b. Enzymatic Disaggregation
. Trypsin based disaggregation or trypsinization:
Warm trypsinization:
Cold trypsinization:
Drawbacks of trypsin disaggregation:
B. Collagenase based disaggregation:
C. Chelating Agents:
3. Seeding of Culture:
Preservation of pharmaceutical products using antimicrobial agents. PHARMACEU...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-3
Preservation of pharmaceutical products using antimicrobial agents.
Introduction. Ideal Properties of Preservatives:
Antimicrobial Chemical Preservatives
Development of a Preservative System.
Factors affecting efficacy of a preservative: 1. Interaction With components of the formulation
2. Properties of the Preservatives:
3) Effect of Containers.
4) Type of microbes:
5) Influence of pH:
Challenge Test: Efficacy Test of Preservative : Medium used, Choice of test organism:
Preparation of the inoculum:
Procedure:
Interpretation of Results:
Assessment of microbial contamination and spoilage. PHARMACEUTICAL MICROBIOLO...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-VPart-2
Assessment of microbial contamination and spoilage.
Assessment of microbial contamination and spoilage
1. Physical and chemical changes:
2. Assessment of viable microorganisms in non-sterile products:
3. Sterility test:
4. Estimation of pyrogens:
Microbial Limit Tests:
Total Aerobic Microbial Count:
Membrane Filtration.
Plate Count Methods.
Pour Plate Method.
Surface spread Method.
Most Probable Number(MPN)
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-V Part-1
Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, source and type of contaminants. Introduction: Defintion Types of Microbial Spoilage:
1. Infection induced due to contaminated pharmaceutical products: Table no. 1.1 Common pathogens spoiling pharmaceutical products:
2. Physicochemical spoilage –
i) Viable growth ii) Gas production
iii) Colouration / Decolouration
iv) Odour formation
v) Taste change
3. Physical Spoilage:
Cracking of emulsion:
Odor changes
4. Biological spoilage:
Microbial Toxins
Microbial Metabolites
5. Chemical spoilage: Table 1.2 Susceptibility of pharmaceutical ingredients to microbial contamination
Factors affecting microbial spoilage
Size of contaminant inoculum
Nutritional factors
Moisture content
pH
Storage temperature
Redox potential
Packaging design
Sources and Types Of Contamination:
Personnel,
Poor facility design,
Incoming ventilation air,
Machinery and other equipment for production,
Raw material and semi-finished material,
Packaging material,
Utilities,
Different media used in the production process as well as for cleaning and Cleanroom clothing.
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T) Unit-IV Part-3
Microbiological Assay of Vitamin & Amino acid Assessment of a New Antibiotic: Introduction:
Principle
Microbiological Assay of Cynocobalamin (Vitamin B12):
Tritrimetric Method.
Turbidimetric Method.
Preparation of Standard Cynocobalmine stock solution:
Preparation of Basal Medium Stock Solution:
Test Solution of the material to be assayed Preparation of inoculum: Procedure of Titrimetric method: Turbidimetric Method: Microbiological assay of Amino acids. Assessment of a New Antibiotic.
Introduction:
MIC of an antibiotic is tested either by one of the following ways,
Liquid Dilution Method.
Solid Dilution Method
Principles and methods of different microbiological assay, methods for standa...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IV Part-2 Principles and methods of different microbiological assay, methods for standardization of antibiotics.
Introduction: Principles Advantages of Microbial Assay: Disadvantages of Microbial Assay: MICROBIOLOGICAL ASSAY OF ANIBIOTICS PRINCIPLE Media used for antibiotics assay Standard Preparation. Buffer Solutions Preparation of the Sample Solution: Test Organisms Preparation of inoculum: Methods of preparation of test organism suspension: Assay Methods: Method A: Cup-plate or Cylinder Plate Method.
Method B: Turbidimetric or Tube assay Method
Designing of aseptic area, laminar flow equipment: Study of different source ...Ms. Pooja Bhandare
Designing of aseptic area, laminar flow equipment: Study of different source of contamination in aseptic area and methods of prevention, clean area classification. PHARMACEUTICALMICROBIOLOGY (BP303T)Unit-IVPart-1
Introduction: Designing of Aseptic Area . i) The clean-up area,
ii) The compounding area,
iii) The aseptic area,
iv) The quarantine area and
v) The packaging/labelling area.
Flow diagram of aseptic area. Floors, walls and ceilings, Doors, windows and services Personnel and protective clothing Cleaning and disinfection. Air Supply. Laminar flow equipment. Vertical laminar air flow bench
Horizontal laminar air flow bench
High Efficiency Particulate Air (HEPA) Filter. Operating Instructions Uses of Laminar Air Flow.Advantages of Laminar Air Flow.Limitations of Laminar Air Flow. Air flow pattern Unidirectional airflow
Non-unidirectional airflow
Combined airflow
Different Sources of Contamination in an Aseptic Area
1) Personnel:
2) Buildings and Facilities
3) Equipment and Utensils:
4) Raw Materials
5) Manufacturing Process:
Methods of Prevention of Contamination Clean Area Classification
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
Evaluation of Bactericidal and Bacteriostatic (Disinfectant). PHARMACEUTICAL ...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-III Part-5 Evaluation of Bactericidal and Bacteriostatic (Disinfectant). The common methods used for evaluation of a disinfectant are as follows,
Tube Dilution Method.
Agar Plate Method.
Filter Paper & Cup Plate Method.
Ditch-Plate Method.
Phenol Coefficient Method.
The official phenol coefficient tests include,
Rideal-Walker Test (RW Test).
Chick-Martin Test.
United States FDA Test for Phenol Coefficient. (FDA Test)
The US Association of Official Agricultural Chemists Test (FDA Test)
A. Rideal-Walker Test:
Kelsey Sykes Method
Factors affecting action of Disinfectants and Factors Affecting Choice Of Ant...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-III. Factors affecting action of Disinfectants and Factors Affecting Choice Of Antimicrobial Agent: Concentration of the disinfectant.
Chemical Structure of the disinfectant.
Formulation of the disinfectant.
Interfering substances in the environment.
pH of the surrounding.
Potentiation and antagonism of the disinfectants.
Surface Tension.
Temperature.
Time of Contact.
Type and no. of microbes present.
FACTORS AFFECTING CHOICE OF ANTIMICROBIAL AGENT:
Properties of chemical agents
Environment
Types of microorganisms
Intended application
Toxicity agents
Culture state
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Acids, Bases And Buffers Pharmaceutical Inorganic chemistry UNIT-II (Part-I)
1. Pharmaceutical Inorganic chemistry
UNIT-II (Part-I)
Acids, Bases And Buffers
Presented By
Ms. Pooja D. Bhandare
(Assistant Professor)
DADASAHEB BALPANDE COLLEGE OF PHARMACY BESA NAGPUR
2. Acids, Bases are defined by Four main theories,
1.Traditional theory / concept
2.Arrhenius theory
3.Bronsted and Lowry theory
4.Lewistheory
3. 1. Traditional theory / concept-Acid:
• Acids: are the substances
• Which converts blue litmus paper to red
• Having the PH<7
• Sour taste
• React with bases to form salts and water
• Eg:-Hydrochloric acid(HCl)
4. 1. Traditional theory / concept-Base:
Base: are the substances
• Which converts red litmus paper to blue
• Having the PH>7
• Bitter taste
• React with Acids to form salts and water
• Eg: Sodium Hydroxide (NaOH)
5. 2. Arrhenius theory:
The Swedish chemist Svante Arrhenius proposed the first definition of acids
and bases
• According to Arrhenius Concept, Acid are substance which are capable of
providing
• Hydrogen ions (H+, proton) when dissolved in water and bases are
substances which are capable
• of providing hydroxide ions (OH-, hydroxyl ions) in aqueous solution.
• For example, Hydrochloric acid in the water, HCl undergoes dissociation
reaction to
• produce H+ ion and Cl– ion, as explained below. The concentration of the
H+ ions is increased by
• forming hydronium ion.
6. • HCl (aq) → H+(aq) + Cl– (aq)
• HCl (aq) + H2O(l) → H3O+(aq) + Cl– (aq)
• Other examples of Arrhenius acids are listed below
• NHO3(aq) + H2O(l) → H3O+ (aq) + NO3–
• In this reaction, nitric acid dissolves in aqueous water to give hydrogen
and nitrate ions.
• Another example of Arrhenius Base is
NaOH + H2O → Na+ + OH- + H2O
7. Neutralization reaction
Acid react Base
Salt &Water
Eg: Hydrochloric acid react sodium hydroxide
Sodium chloride (Salt) & water
NaOH + HCl------------------- NaCl + H2O
8. • “Neutralization as the process in which hydrogen ion and hydroxyl ion
combine to form unionized molecule or water”
• NaOH + HCl------------------- NaCl + H2O
• HCl (aq) → H+(aq) + Cl– (aq)
• NaOH + → Na+ + OH-
• H+ + OH- → H2O
10. Limitations of Arrhenius theory:
• The Arrhenius theory is applicable only in aqueous solution; for example, according to the
theory, HCl is an acid in the aqueous solution but not in benzene, even though it donates H+
ion to the benzene. Also, under Arrhenius’s definition, the solution of sodium amide in liquid
• ammonia is not alkaline, even though amide ion deprotonates the ammonia.
• Basisity of Ammonia (No OH-ion)is not explained
• Acidity of BF3,AlCl3 (No H+ ion)is not explained
• Acidity of oxides of P block element (CO2) is not explained
• Basicity of oxides of S block element (Na2o)is not explained
• Neutralization with out absence of solvent is not explained
11. 3.Bronsted -Lowry concept:
Bronsted -Lowry concept: In 1923 the Danish chemist Johannes Nicolaus Bronsted
and the English chemist Thomas Martin Lowry, proposed the theory.
• According to Bronsted-Lowry theory, An acid is any substance (molecular or ionic)
that can donate a proton to any other substance (molecular or ionic) and a base is
any substance that can accept a proton from anyother substance.
• HCl + H2O H3O+ + Cl
• In the above example what is the Bronsted acid? What is the Bronsted base?
In reality, the reaction of HCl with H2O is an equilibrium and occurs in both
directions, although in this case the equilibrium lies far to the right.
HCl + H2O H3O+ + Cl-
12. • For the reverse reaction Cl- behaves as a Bronsted base and H3O+
behaves as a Bronsted acid.
• The Cl- is called the conjugate base of HCl. Bronsted acids and bases
always exist as conjugate acid-base pairs. Their formulas differ by only
one proton.
• Acid Base conjugate acid conjugate base
HCl + NH3 NH4+ + Cl-
13. 1.Amphoteric: a species that can act as an acid or a base water is an
example of an amphoteric species.
2.Conjugatebase: species that remains after an acid donates its H+.
3.Conjugateacid: species that forms after a base accepts a H+
• 14
14. • Every Arrhenius Acid is Bronsted Acid
• Every Arrhenius Base is not Bronsted Base e.g., NaOH is Arrhenius base
because it gives
• OH- ion in aqueous solution but not a Bronsted base because it cannot accept
proton.
• Limitations of Bronsted Lowry Concept:
• The protonic definition cannot be used to explain the reactions occurring in
non-protonic solvents such as COCl2, SO2, N2O4, etc.
• Substances like BF3, AlCl3 etc, do not have any hydrogen and hence cannot
give a proton but are known to behave as acids
15. Lewis Theory
• In 1923 of scientist G.N. Lewis proposed the theory in terms of chemical
structure.
• Lewis Acids:
• Lewis acids accept an electron pair. Lewis Acids are Electrophilic meaning
that they are electron attracting.
• Various species can act as Lewis acids. All cations are Lewis acids since
they are able to accept electrons. (e.g., Cu2+, Fe2+, Fe3+)
• Lewis acids- H+, NH4+, Na+, K+, Cu2+, Al3+, etc.
16. • Lewis Bases
• Lewis Bases donate an electron pair. Lewis Bases are Nucleophilic meaning that they
“attack” a positive charge with their lone pair. An atom, ion, or molecule with a lonepair of
electrons can thus be a Lewis base.
• Lewis base- NH3, H2O, OH-, Cl-, CN-, S2-, etc.
• (Lewis base) (Lewis acid)
• Boron trifluoride accepts the electron pair, so it is a Lewis acid. Ammonia makes available
(donate) the electron pair, so it is the Lewis base.
17. Importance of acids and bases in pharmacy
• Acids, bases and their reaction play vital role in pharmacy practice. Some of the
main application of the these are as follows:
• Acid-base neutralization reaction finds use in preparative procedures for the
preparation of suitable salt, and for conversion of certain salts into more suitable
forms.
• Acid-base is used in analytical procedure which is involving acid-base titrations.
• Acids and bases find use as therapeutic agents in the control of and adjustment of
pH of the GI tract, body fluids and urine.
18. Buffers:
• A buffer is a solution that can resist pH change upon the addition of an
acidic or basic components.
• It is able to neutralize small amounts of added acid or base, thus
maintaining the pH of the solution relatively stable.
• •This is important for processes and/or reactions which require specific
and stable pH ranges.
19. • Buffers: Buffers are defined as a compound or a mixture of compounds
that resists the pH upon the addition of small quantities of acid or alkali.
Buffer have definite pH value.
• The pH will not change after keeping it for a long period of time. The pH
value altered negligibly by the addition of small quantities of acid or base.
• Buffer action: The resistance to a change in pH is known as buffer action.
So buffers can be added to show buffer action.
• Buffer capacity: The amount of acid/base required to produce a unit
change in pH in a solution is called buffer capacity.
20. Buffers system:
• A buffer system can be made of a weak acid and its salt or a weak base
and its salt.
• A classic example of a weak acid based buffer is acetic acid
(CH3COOH) and sodium acetate(CH3COONa).
• A common weak base buffer is made of ammonia (NH3) and ammonium
chloride (NH4Cl)
21. Types of Buffers :
Generally buffers are of two types:
1. Acidic buffers
2. Basic buffers
There are some other buffer system:
3. Two salts acts as acid-base pair. Ex- Potassium hydrogen phosphate and potassium
dihydrogen phosphate.
4. Amphoteric electrolyte. Ex- Solution of glycine.
5. Solution of strong acid and solution of strong base. Ex- Strong HCl with KCl.
22. 1. Acidic Buffers:
• An acidic buffer is a combination of weak acid and its salt with a strong
base. i.e. Weak acid & salt with strong base (conjugate base).
• EXAMPLES:
CH3COOH / CH3COONa
H2CO3 / NaHCO3
H3PO4 / NaH2PO4
HCOOH / HCOONa
23. 2. Basic Buffers:
• A basic buffer is a combination of weak base and its salt with a strong
acid.i.e. Weak base & salt with strong acid (conjugate acid).
• EXAMPLES:
NH4OH / NH4Cl
NH3 / NH4Cl
NH3 / (NH4)2CO3
24. Mechanism of Buffer action:
Mechanism of Buffer action:
• The resistance of a buffer solution to a change in pH is known as buffer action.
• In a buffer solution, the components interact with each other and produce a
dynamic equilibrium.
• When a small quantity of acid or base is added, the dynamic equilibrium shifts
and nullifies the effect of the addition.
25. Mechanism of Action of acidic
buffers:
• Consider a buffer system of CH3COOH (Weak electrolyte) and CH3COONa (Strong
electrolyte). There will be a large concentration of Na+ ions, CH3COONa – ions,
and undissociated CH3COOH molecules.
When an acid is added:
• If a strong acid (HCl) is added in CH3COOH / CH3COONa buffer, the changes that
will occur may be represented as:
CH3COONa Na + COO H + Cl
CH3COOH
• The hydrogen ions yielded by the HCl are quickly removed as unionized acetic acid,
and the hydrogen ion concentration is therefore only slightly affected (because acetic
acid produced is very weak as compared to HCl added).
-
- +
+
26. When a base is added:
• If a strong base (NaOH) is added in NH4OH / NH4Cl buffer, the changes
that will occur may be represented as:
CH3COOH CH3COO + H OH + Na NaOH
H2O
• The hydroxyl ions yielded by the NaOH are therefore removed as water. The
supply of hydrogen ions needed for this purpose being constantly provided
by the dissociation of acetic acid..
+
+
-
-
27. Buffer equation-Henderson-Hasselbalch equation:
• The buffer equation is also known as Henderson-Hasselbalch equation,
with the help of this equation it is possible to calculate the pH of a buffer
solution of known concentration or to makebuffer solution of known pH.
• Two separate equations are obtained for each type of buffer, acidic and
basic
• pH of acidic buffer: The hydrogen ion concentration obtained from the
dissociation of weak acid HA is given by equation,
28. HA H+ + A-
𝐾𝑎 =
[H+][A−]
[HA]
Ka = equilibrium constant
[H+] = 𝐾𝑎
[HA]
[A−]
Taking logarithms of both sides of the equation & multiplying throughout by -1
gives
-log[H+] = -log𝐾𝑎-log
[HA]
[A−]
pH= pKa + log
[A−]
[HA]
𝑝𝐻 = 𝑝𝐾𝑎 + log
[congugated base]
[Acid]
29. pH of an alkaline buffer: The ionization of a weak base BOH is given by,
BOH B+ + OH-
𝐾b =
[B+][OH−]
[BOH]
Kb = equilibrium constant
[OH−] = 𝐾b
[BOH]
[B+]
Taking logarithms of both sides of the equation & multiplying throughout by -1
gives
-log[OH−] = -log𝐾𝑎-log
[BOH]
[B+]
pH= pKa + log
[B+]
[BOH]
𝑝𝐻 = 𝑝𝐾𝑎 + log
[Congugated acisd]
Base]
30. Buffer capacity:
• Buffer capacity may also be defined as “The maximum amount of either
strong acid or strong base that can be added before a significant change in
the pH will occur”.
• The maximum amount of strong acid that can be added is equal to the
amount of conjugate base present in the buffer whereas the maximum
amount of base that can be added is equal to the amount of weak acid
present in the buffer.
31. • Buffer capacity is depend on the factors:
1. The concentration of the acid or base component of the buffer (Direct relation)
2. The pH of the buffer
• Buffer can act best at pH = pKa and buffering range is pH = pKa +1
• Or It may be defined as the moles of strong acid or strong base required to change
the pH of 1000 ml of buffer solution by one unit.
• The magnitude of the resistance of a buffer to pH changes is referred to as the
buffer capacity, β.
• Where, ΔB is the small increment in gram equivalents (g Eq)/liter of strong base
added to the buffer solution and ΔpH: change in a pH
32. Standard Buffer Solutions:
• The standard buffer solutions of pH ranging from 1.2-10 are possible to
prepare by appropriate combinations of 0.2N HCl or 0.2N NaOH or 0.2M
solution of potassium hydrogen phthalate, potassium dihydrogen phosphate,
boric acid, potassium chloride.
• Standard buffers with pH range:
Buffer pH
Hydrochloric acid buffer 1.2-2.2
Acid Phthalate buffer 2.2-4.0
Neutralised phthalate buffer 4.2-5.8
Phosphate buffer 5.8-8.0
Alkaline Borate buffer 8-10
33. Preparation of Buffer Solutions:
Weak acid with pKa = desired pH should be selected
↓
Ratio of salt and acid needed should be calculated using buffer equation
↓
Individual concentration of buffer salt and acid determined.
↓
Ingredients are dissolved in carbon dioxide free water
↓
Buffer capacity of 0.01-0.1 is adequate
↓
Concentration of 0.05-0.5 M is sufficient
↓
Allowed to establish equilibrium
↓
pH verified.
34. Buffers in pharmaceutical systems or
Application of buffer:
1. Solubility enhancement: The pH of the pharmaceutical formulations are adjusted to an
optimum value so that the drug remains solubilised though out its shelf-life and not precipitated
out.Eg. Sodium salicylate (Asprin) precipitates as salicylic acid in acidic environment.
2. Increasing stability: To prevent hydrolysis and for maximum stability, the pH of the
medium should be adjusted suitably. Eg. Vitamins
3. Improving purity: The purity of proteins can be identified from its solubility at their
isoelectric point as they are least soluble at this point. The isoelectric pH can be maintained
using suitable buffers . Eg. Insulin precipitates from aqueous solution at pH 5.0-6.0.
4. Optimising biological activity: Enzymes have maximum activity at definite pH values.
Hence buffer of desired pH is added to the preparation.
35. 5. Comforting the body: The pH of the formulations that are administered to different tissues of the body should
be optimum to avoid irritation (eyes), haemolysis (blood) or burning sensation (abraded surface). The pH of the
preparation must be added with suitable amount of buffers to match with the pH of the physiological fluid.
Eg: buffer in various dosage forms
Dosage Form Application Buffer used
Solids (Tablets,
Capsules, powder)
Control pH for release.
Reduce gastric irritation
Citrate buffer,
Phosphate buffer
Semisolids (Creams,
Ointments)
Stability Citric acid and
sodium citrate
Parenteral Products pH maintenance (pH
high: tissue, necrosis
pH low: pain)
Citrates, glutamate,
acetate, phthalate
Opthalamic products Drug solubility and
stability
Borates, carbonates,
phosphates
36. Stability of buffers
• Treat buffer solution with care.
• The typical shelf-life for commercial technical buffer is 2 years unopened and 3-6
month open.
• The typical shelf life of alkaline buffer is 1 month open.
• Alkaline buffer = change with dissolved air and form carbonic acid which decreased
pH of the solution.
• Maintain at 25°C
• Preserved in colored bottle.
• Storage condition maintain for inhibition of growth of microorganism.
37. Buffered isotonic solution:
• Isotonic buffered solution is defined as a solution which maintains the isotonicity
and the pHas that of the body fluids. Isotonic buffer solution should be compatible
with the body fluids for the following reasons.
• Blood and lacrimal fluids are in vivo buffer systems. Any solution that comes in
contact with these fluids should be buffered to a desired pH, so that these are
compatible with the body fluids.
• Some solutions are meant for the application on delicate membranes of the body.
Such solutions may cause haemolysis, tissue irritation, necrosis and tissue toxicity.
In such cases, solutions must be just to the same osmotic pressure and tonicity as that
of the body fluids.
38. • Osmosis is the diffusion of solvent through a semi-permeable membrane.
• Water always flows from lower solute concentration [dilute solution] to higher
solute concentration until a balance is produced
• Osmotic pressure is the force that cause this diffusion .
• Tonicity is a measure of the osmotic pressure of two solutions separated by a
semi-permeable membrane.
40. 1. Isotonic Solutions:
• Isotonic solutions are those solutions which produce the same osmotic pressure as that of the cell
contents in question, without net gain or loss of both solutions, provided the cell membraneis
impermeable to the solutes.
• Isotonic solutions are iso-osmotic as well as isotonic with the cells and membranes. Some of the
standard isotonic solutions are:
0.9% w/v Normal saline (sodium chloride) solution
5.0% w/v Dextrose solution
2.0% w/v Boric acid solution
These solutions do not cause swelling or shrinking of tissues when applied. Therefore, discomfort
would not be caused when instilled into the eyes, nasal tract and when injected intoblood or other body
fluids.
41. • In the human body, different types of cell membranes are available. All are
not having same- level of permeability to a single substance. For example,
red blood cell membrane and mucous lining of the eye are not the same.
• Therefore, isotonic solutions of 0.9% w/v sodium chloride also need not
necessarily be isotonic with respect to all the living membranes, but many
of them are roughly isotonic.
42. 2. Hypertonic Solutions:
• Hypertonic solutions are defined as those solutions containing the solute in
higher concentration than that is required for isotonic solutions. Some
hypertonic solutions are:
• 2.0% w/v Normal saline (sodium chloride) solution (concentration > 0.9 %
w/v).
• 10.0 % w/v Dextrose solution (concentration > 5.0% w/v).
• 3.0 % w/v Boric acid solution (concentration > 2.0% w/v).
43. • When red blood cells are suspended in a 2.0 % w/v solution of sodium
chloride, the water within the cells passes out through the cell membranes
in an attempt to dilute the surrounding salt solution.
• This process continues until the salt concentrations on both sides of the
erythrocyte membrane are equal.
• Thus outward passage of water causes the cells to shrink and becomes
wrinkled or crenated. Such a salt solution is said to be hypertonic with
respect to blood.
44. 3. Hypotonic Solution:
• Hypotonic solutions are defined as those solutions containing the Solute in lower
concentration than that is required for isotonic solutions
• Some hypotonic solutions are:
0.2% w/v Normal saline (sodium chloride) solution (concentration < 2.0 % w/v).
• When blood cells are suspended in a 0.2 % w/v solution of sodium chloride (or in
distilled water), water enters the blood cells causing them to swell and finally burst
with the liberation of haemoglobin.
• This process is known as haemolysis. Such a weak salt solution is said to be
hypotonic with respect to blood
45.
46. Measurement of Tonicity
• Isotonicity value is defined as the concentration of an aqueous sodium chloride
solution having same colligative properties as the solution in blood.
• Apart from sodium chloride, a number of chemicals and drugs are also included
in the formulations. These ingredients also contribute to the tonicity of the
solution. Therefore, methods are needed for verifying the tonicity and adjusting
the tonicity
47. 1. Hemolytic method:
• Red blood cells (RBCs) are suspended in various drug solutions and the
swelling of RBCs is observed bursting, shrinking and wrinkling of the
blood cells.
• In hypotonic solutions, oxyhemoglobin is released, which is in direct
proportion to the number of cells hemolyzed.
• In hypertonic solutions, the cells shrink and become wrinkled or crenated
• In isotonic solutions, the cells do not change their morphology. This
method is used for the determination of isotonicity value.
48. 2. Cryoscopic method or depression of freezing
point:
• Colligative properties of solutions are helpful in determining the isotonicity
values. Among them, freezing point depression is extensively applied.
• Water has the freezing point of 0 °C. When substances such as sodium chloride
are added to water, the freezing point of water decreases.
• The depression of the freezing point (ΔTf) of blood and tears is 0.52 °C.
Therefore, the value of 0.9 % w/w NaCl solution should also be -0.52 °C. Such
a solution shows same osmotic pressure as that of the blood. Hence, the
functions of RBC and tissues do not alter.
49. Methods of adjusting the tonicity:
• Normally, solution dosage forms contain drugs of desired dose and several
excipients needed for formulation. In order to render such solutions isotonic,
sodium chloride, dextrose, etc. are added. Several methods are available for
adjusting the tonicity.
• Osmotic pressure is not a readily measurable quantity, but freezing point
depression (another colligative property) is more easily measured.
50. Class I methods:
In this type, sodium chloride or other substances are added to the solution in
sufficient quantity to make it isotonic. Then the preparation is brought to its
final volume withan isotonic or a buffered isotonic diluting solution.
These methods are of two types:
Cryoscopic method
Sodium chloride equivalent method.
51. Class II methods:
• In this type, water is added in sufficient quantity make the preparation
isotonic. Then the preparation is brought to its volume with an isotonic or a
buffered isotonic diluting solution.
• These methods are of two types:
White-Vincent method
Sprowls method.
52. 1. Cryoscopic Method of Adjusting the Tonicity:
Principle:
• Water has the freezing point of 0 °C. Blood contains a number of substances such as carbonic acid,
carbonates, salts of phosphoric acid and hemoglobin. As a result, the depression in the freezing point
of the blood is -0.52 °C.
• When substances such as sodium chloride are added to water, the freezing point of water decreases.
The extent of depression in the freezing point depends on the concentration of the added substance.
• For example, sodium chloride at 1 % w v solution decreases the freezing point of water to - 0.58°. In
order to make the drug solution isotonic, the freezing point depression of the solution must be
maintained at-0.52°.
53. • Initially the drug solution is prepared whose depression in the freezing
point (ΔTf) is known. The remaining (ΔTf) value is adjusted by adding
additional substances such as sodium chloride.
• For the purpose of calculate, the freezing point depression of a number of
drugs are determined experimentally or theoretically a concentration of 10
% w/v (or sometimes 0.5 % w/v). Similarly the freezing point depression
values of 1 w/v solution of sodium chloride and other general ingredients
are also determined.
54. Derivation:
Freezing point depression (ΔTf) of blood is 0.52°C. Since the drug solution must be isotonic, it must have ΔTf,
same as that of the blood, i.e. ΔTf = 0.52°C.
Total drug solution ΔTf = ΔTf of drug + ΔTf adjusting substance ---------- (1)
Freezing point depression (ΔTf) of the total drug solution = 0.52°C
ΔTf value of the drug = x X ΔTf of 1 % drug solution = d
Where,
x = drug concentration in the preparation, g/100 mL
ΔTf for adjusting solution = w X a
Where,
W = weight of the adjusting substance, g/100 mL
a = ΔTf of the adjusting substance (sodium chloride), 1% (=0.58)
For an isotonic solution, equation (1) is substituted by the terms mentioned above. 0.52° = d + wa
55. The % w/v of adjusting substance needed is:
W= (0.52-d)/a = (0.52-d)/0.58 --------- (2)
Equation (2) is valid, if 1 % drug solution is specified. For any given percentage strength of
medicament (PSM), equation (2) may be modified as:
W= [0.52- (PSM x d)]/ 0.58 ----------- (3)
Thus, the desired concentration of adjusting substance is calculated and added in order to make the
drug preparation isotonic with blood. Each solute exerts its effect on the freezing point, although
others are present.
Hence, if two or more substances are present, a sum of their freezing point depression should be
considered.
• Advantage:
• Determination of depression in the freezing point is much simpler and more convenient.
56. 2. Sodium Chloride Equivalent Method:
• Tonicity equivalent or sodium chloride equivalent method is used to adjust the tonicity of
pharmaceutical solutions.
• Sodium chloride equivalent (D) of a drug is the amount of sodium chloride that is
equivalent to 1 g of the drug. In this definition, equivalent refers to sodium chloride
concentration having the same osmotic effect as that of the drug. In the absence of
available data, the E value of a new drug can be calculated from equation (4).
• E= [17 X Liso]/M -------------- (4)
• Where,
• M = molecular mass, AMU
• Liso = freezing point depression constant of the drug.
57. Method:
The percent of sodium chloride required for adjusting isotonicity can be calculated
using equation (5).
PSA = 0.9 - (PSM E of medicament) ----------- (5)
Where,
PSM= Percent strength of medicament
PSA = Percent of sodium chloride for adjustment of isotonicity.
Equation (5) is used to calculate the amount of adjusting substance (sodium
chloride) required for making the solution isotonic. It is valid for 100 mL solution.
58. 1. White-Vincent Method
• This method involves the addition of water to the given amount of drug to
make isotonic solution, followed by the addition of some other isotonic
solution (e.g. 0.9% NaCl) to make the final volume.
• White Vincent, from their study of need of pH adjustment in addition to
tonicity of ophthalmic solution, developed an equation The volume of
water that should be added in given amount of drug to make isotonic
solution is calculated by using:
𝑉 = 𝑊 × 𝐸 × 111.1
Where,
• V = volume of water needed to make isotonic solution
• W = given weight of drug in grams
• E = NaCl equivalent value of drug
• 111.1 = constant
59. • NUMERICAL: Make 50 ml isotonic solution from 0.5 gm of boric acid.
E value of boric acid is 0.50. Solution:
• Given amount of boric acid = 0.5 gm
• Required volume = 50 ml
• E value of boric acid = 0.50
• Fistly, we calculate the amount of the water that should be added in 0.5
gm of boric acid to make isotonic solution by using formula,
𝑉 = 𝑊 × 𝐸 × 111.1 𝑉 = 0.5 × 0.5 × 111.1 = 27.8 𝑚𝑙
So, 0.5 gm of boric acid is added in 27.8 ml of water to male isotonic
solution. But, final volume that is required is 50ml. so, remaining 22.2ml of
some other isotonic solution (e.g. 0.9% NaCl) are added to make up final
volume 50 ml.
60. 2. Sprowl Method:
• Sprowls method is a simplification of White-Vincent method in which
values of V for the drug of fixed weight (0.3 g) are computed and
construed.
• This is commonly used for ophthalmic and parental solutions.
𝑉 = 𝑊 × 𝐸1% × 111.1 𝑜𝑟 𝑉 = 33.33 × 𝐸1%