REPORT OF PRACTICE SCHOOL

BY

SHRITEJ.S.MANUSMARE

B.PHARM SEM VII

Priyadarshini J.L. College of Pharmacy

Electronic zone building, MIDC, Hingna road, Nagpur- 440016
 INDEX
MODULE NO MODULE NAME

1 FORMULATION DEVELOPMENT

2 MOLECULAR BIOLOGY AND CELL CULTURE

TECHNIQUES
3 QC AND QA OF PHARMACEUTICALS

4 DRUG DESIGN AND PROCESS CHEMISTRY

5 EXPERIMENTAL PHARMACOLOGY

6 HERBAL TECHNOLOGY
 MODULE 1: FORMULATION DEVELOPMENT
TITLE: STANDARD OPERATING PROCEDURE OF COLORIMETER

STANDARD OPERATING SYSTEM:

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The
development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job
properly, and facilitates consistency in the quality and integrity of a product or end-result.

POINTS OF CONSIDERATION PERFORMANCE MANAGEMENT

SIMPLIFICATION:
• Quality Management. • Performance on any work
• Write some SOPs for two or more people who • Managing work schedule
work together as a team.

• Performance Simplification.

QUALITY MANAGEMENT: HOW TO WRITE SOPS:

• Use Plain Language.
• Maintain highest quality of product.
• Steps should be explained thoroughly.
• Ensuring best quality and proper results.
• Don’t include steps outside the organization
 STANDARD OPERATING PROCEDURE OF COLORIMETER

COLORIMETER:
Colorimetry is the measurement of the wavelength and the intensity of electromagnetic radiation in the visible region of the spectrum. A colorimeter is an
instrument that compares the amount of light getting through a solution with the amount that can get through a sample of pure solvent.
PROCEDURE:
1. Switch on the Colorimeter by switch
2. Wait for 2 Minute until the tuctation will not stop
3. Set the %Tat zero
4. Take the Cuvette and clean it very property.
5. There should not be any trace on the surface of the Cuvette
6. Fill the amount with Liquid in the Cuvette which we are going to measured.
7. Place the Light Shield in the box (Black in color)
8. Place the Cuvette very slowly in the Cuvette chamber.
9.Wait for 1 minute and note down the Optical Density of the given liquid material

10.Switch off the Instrument.

The Colorimeter should not be stored or used in a wet or conosive environment. Care should be taken to prevent water from wet colorimeter tubes from entering
the colorimeter light chamber.
 MODULE NO 2: MOLECULAR BIOLOGY AND CELL CULTURE TECHNIQUES
TITLE: GENOME EDITING
GENOME EDITING:
Genome editing, also called gene editing, is an area of research seeking to modify genes of living organisms to improve our understanding of gene function and
develop ways to use it to treat genetic or acquired diseases.

(DIFFERENT APPROACHES OF GENOME EDITING)

A) ZINC FINGER NUCLEASES B) TRANSCRIPTION- ACTIVATOR

(ZFN): LIKE EFFECTOR NUCLEASES
• Introduce frame-shift mutations into the coding (TALENs):
sequence of a gene due to the error-prone nature of •  Insertions in human somatic and pluripotent
the non-homologous DNA repair pathway. stem cells using double-stranded donor
templates.

C) CLUSTERED REGULARLY
INTERSPACED SHORT
PALINDROMIC REPEATS (CRISPR):
• Found in the genomes of prokaryotic organisms
such as bacteria and archaea. ... They are used to
detect and destroy DNA from similar
bacteriophages during subsequent infections.
 D) HOMOLOGOUS RECOMBINATION: E) HOMING ENDONUCLEASES
• It is a type of genetic recombination in which nucleotide sequences • The homing endonucleases are a collection of endonucleases encoded
are exchanged between two similar or identical molecules of DNA. either as freestanding genes within introns, as fusions with host
proteins, or as self-splicing intines

• Homologous recombination is a type of genetic recombination that • Homologous recombination is a type of genetic recombination that
occurs during meiosis (the formation of egg and sperm cells). occurs during meiosis (the formation of egg and sperm cells).
 MODULE NO 3: QUALITY CONTROL AND QUALITY ASSURANCE OF PHARMACEUTICALS
TITLE: AEROSOLS

QUALITY ASSURANCE :
QUALITY CONTROL:
. Quality Assurance (QA) activities include a
Quality Control (QC) is a system of routine technical
planned system of review procedures conducted by
activities, to measure and control the quality of the
personnel not directly involved in the inventory
inventory as it is being developed.
compilation/development process

OBJECTIVES OF IN-PROCESS QUALITY CONTRO [IPQC]:

• Quality standards which are acceptable to the customers
• Variations in the raw materials ensure smooth and uninterrupted
production.
• Evaluate the methods and processes for improvement in production
• Analyse in detail the causes responsible for such deviation.
 IMPORTANCE OR BENEFITS OF QUALITY COMPONENTS OF PHARMACEUTICAL
CONTROL AEROSOL:
• PROPELLANT:
• ENCOURAGES QUALITY CONSCIOUSNESS
• CONTAINERS:
• SATISFACTION OF CONSUMERS • VALVE:
• ACTUATOR:
• REDUCTION IN PRODUCTION COST
• MOST EFFECTIVE UTILISATION OF RESOURCES
AEROSOL SYSTEMS ARE CLASSIFIED
• REDUCTION IN INSPECTION COSTS
• SOLUTION SYSTEM OR TWO PHASE SYSTEM:
• INCREASED GOODWILL • WATER BASED SYSTEM OR THREE PHASE SYSTEM
• IMPROVED EMPLOYER-EMPLOYEE RELATIONS • FOAM SYSTEM:

• EFFECTIVE ADVERTISEMENT

PHYSICOCHEMICAL CHARACTERISTICS
• VAPOR PRESSURE
TEST FOR AEROSOL
• DENSITY
• SPRAY TESTS
• MOISTURE CONTENT
• LEAK TEST
• IDENTIFICATION OF PROPELLANT
• WEIGHT CHECK
• PROPELLANTS TEST
• TOXICITY TEST PERFORMANCE
• AEROSOL VALVE DISCHARGE RATE
FLAMMABILITY AND COMBUSTIBILITY • LEAKAGE
• FLASH POINT
• NET CONTENT.
• FLASH EXTENSION AND FLASH BACK
 MODULE 4: DRUG DESIGN AND PROCESS CHEMISTRY
TITLE: CADD OF AVTIAN AND PROCESS CHEMISTRY

PROCESS CHEMISTRY:
FILTRATION:
• The process in which solid particles in a liquid or gaseous fluid are removed by the use of a filter medium that permits the fluid to pass through but retains the
solid particles.
• In some processes used in the production of chemicals, both the fluid filtrate and the solid filter cake are recovered.

DISTILLATION,
• Distilation process involving the conversion of a liquid into vapour that is subsequently condensed back to liquid form.

• It is exemplified at its simplest when steam from a kettle becomes deposited as drops of distilled water on a cold surface .
EXTRACTION
• Extraction in chemistry is a separation process consisting of the separation of a substance from a matrix. Common examples include liquid-liquid extraction
and solid phase extraction.
ISOLATION:
• Isolation is used in organic chemistry to separate individual compounds from a more complex matrix.

CRYSTALIZATION:
• 1. In chemistry, recrystallization is a technique used to purify chemicals.
• 2. By dissolving both impurities and a compound in an appropriate solvent, either the desired compound or impurities can be removed from the solution,
leaving the other behind.
 CADD AVITIAN
• Ativan is a prescription medicine used to treat the symptoms of anxiety disorders. Ativan may be used alone or with other medications.
• Ativan belongs to a class of drugs called Antianxiety Agents Anxiolytics, Benzodiazepines, Anticonvulsants, Benzodiazepine.

FLOW OF WORK:
DOWNLOADING OF SOFTWARE PROGRAMM:
Chemsketch : Draw and modify images of chemical structures molecular
models displayed in two and three dimensions.
Avogadro: Molecule editor and visualize designed convert a mol file to
.pdb format.
PyRx: Computational drug discovery that can be used to screen libraries of
compounds against potential drug targets.
Discovery studio: It is used for molecular interaction and visualization.
PREPARATION OF LIGAND:
• Avtian structure was drawn using chem sketch Softwarecleaned by using
the Clean structure tool and aved in the working folder as .mol file,is
converted to pdb format the .mol file.
• Open the chrome and then open software molinspiration.
• Enter the smiles and calculate the properties and bioactivity.
• After completion of above step open a new tab and search swiss target
prediction.

PREPARATION OF RECEPTOR:
VIRTUAL SCREENING:
• Open the PDB (PROTEIN DATA BANK) site and search the 6DRX
which is a protease and download the structure of 6DRX in pdb format • Now the PyRx software is used for virtual screening protocols.
from the online database • The Vina Wizard module was started and selected the Ligand and the
• The pdb format is opened in the discovery studio and then press Ctrl + H Macromolecule and converted into.pdbqtformats.
and then remove the pre-associated Ligand present in the protease and the • The grid was selected and the Screening was carried out.
active sites were identified and then saved in the working folder as pdb
file.
 MODULE NO 5: EXPERIMENTAL PHARMACOLOGY
TITLE: CLINICAL RESEARCH AND PHARMACOVIGILANCE

PHARMACOVIGILANCE:
• Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and
prevention of adverse effects with pharmaceutical products.
• Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and
prevention of adverse effects with pharmaceutical products.

RISK MANAGEMENT:
PHARMACOVIGILANCE AND ITS OWN UNIQUE
TERMINOLOGY : • CAUSALITY ASSESSMENT:
• Adverse Event Reporting • SIGNAL DETECTION:
• Expedited Reporting • RISK MANAGEMENT PLANS:
• Clinical Trial Reporting • RISK/BENEFIT PROFILE OF DRUGS

• Spontaneous Reporting:
 CLINICAL RESEARCH

• The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction
to the consumer market and beyond.
• Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the
test article.

DIFFERENT PHASES TO CLINICAL RESEARCH: DIFFERENT TYPES OF CLINICAL RESEARCH

TREATMENT RESEARCH
• PREVENTION RESEARCH:
• DIAGNOSTIC RESEARCH:
• SCREENING RESEARCH:
• QUALITY OF LIFE RESEARCH
 MODULE NO 6: HERBAL TECHNOLOGY
TITLE: KURCHI

BIOLOGICAL SOURCE: CHEMICAL CONSTITUENT:

• Kurchi bark consist of dried stem bark of Halarrhena
antidysenterica
(H.pubescens).
• It also known as Halorrhenna.
• The bark of kurchi is collected from the tree by
making suitable transverse or longitudinal incision.
• Kurchi belongs to the Apocynaceae family
• Alkaloidal constituents in bark vary from 1.8% to 4.5%
• Conessine is the main steroidal alkaloid vary from 20% to
30%.
• Consist of gum, resin, tannin, lupeol and digitenol
glycoside holadysone as chemical composition.

BIOACTIVE COMPOUNDS:
1) CONESSINE: 2) KURCHESSINE:
INDUSTRIAL PRODUCTION OF BIOACTIVE INSTUMENTAL METHOD FOR ITS IDENTIFICATION BY
COMPOUND:
CHROMATOGRAPHY TECHNIQUE HPTLC
• The cultivation, conessine content and harvesting methodology
• Mother tinctures purchased from the market were labelled as B, C and D.
for Holarrhena floribunda were investigated. Allometric
• Chromatographic separation was scanned at 254 nm and 366 nm.
measurements are proposed as prediction tools for estimation
• At 254 nm, five spots appeared in in-house mother tincture
of trunk total productions of bark and conessine.
a) Five spots appeared in market sample (A) at f0.20, 0.35, 0.44, 0.73 and 0.87.
• A linear relationship found between stem diameter and bark
b) Five spots appeared in market sample(B) at f0.21, 0.33, 0.46, 0.72 and 0.86.
conessine content allowed the establishment of log-log
c) Four spots appeared in sample (C) at f0.34, 0.43, 0.74 and 0.88.
correlations between trunk circumference and trunk production
d) Four spots appeared in sample (D) at 0.36, 0.42, 0.71 and 0.86 (all brown).
of bark and conessine.
• The HPTLC chemo profiling of in-house mother tincture (A) and market sample
• Harvesting of a five years old culture by a coppicing method
(B, C and D) was almost similar. However, excess amount of active constituents
could be estimated at 976 kg/ha of stem bark and 7.8 kg/ha of
were found in in-house homoeopathic drug/tincture (A) rather than the market
conessine. Stems of diameter < 0.5 cm present little interest for
samples (B, C and D). These may be considered as valuable standards in
alkaloid production and should be discarded. pharmacopoeia and act as vital fingerprint parameters

USES
Dysentery. Blood disorders.
Excessive mucus. Fever and other conditions.
Worms. Diarrhoea.
Thank You