This document discusses the formulation, production, packaging, and sterilization of parenteral products. It covers various parenteral dosage forms including solutions, suspensions, emulsions, and dry powders. Production methods like sterile filtering, freeze-drying, spray drying and aseptic crystallization are described. Considerations for packaging, sterility validation, and ensuring quality are also summarized.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Semisolid, Ideal properties of semisolid, Advantage of semisolid dosage form, Ingredients used in semisolid preparation, Evaluations of ointment, cream and pastes, Equipment used in formulation of semisolid, Troubleshooting in semisolid dosage form.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Semisolid, Ideal properties of semisolid, Advantage of semisolid dosage form, Ingredients used in semisolid preparation, Evaluations of ointment, cream and pastes, Equipment used in formulation of semisolid, Troubleshooting in semisolid dosage form.
Almost Exact Procedure is provided in each & every slide ..
Thanks & Best Regards
Anurag Pandey (B.Pharm)
Contact :- anurag.dmk05@gmail.com (Facebook & Gmail)
STERILITY TESTING OF PHARMACEUTICALS ppt by DR.C.P.PRINCEDR.PRINCE C P
Sterility Testing: done to detect if viable forms of micro-organisms are present or not on or in the pharmaceutical preparation.
The test is applied to substances or preparations which, according to the Pharmacopoeia, are required to be sterile. For example
✦ Injections
✦ Implants
✦ Syringes
✦ Bandages
✦ Dressings
✦ Surgical Instruments
✦ Needles
✦ Injectables
✦ Bulk Solids
✦ Ophthalmic Products..etc
If microorganisms are placed in a media that provides nutrients and water and kept at a favourable temperature the organism will grow and their growth can be indicated by turbidity in originally clear medium.
PPT prepared by:
DR.PRINCE C P
HOD &Associate Professor
Department of Microbiology,
Mother Theresa Post Graduate & Research Institute of Health Sciences (Government of Puducherry Institution)
Pilot plant Techniques and Product consideration for liquid dosage forms.D.R. Chandravanshi
CONTENTS:-
DEFINITION
INTRODUCTION
OBJECTIVES
LIQUID DOSAGE FORM
STEPS INVOLVED IN PILOT PLANT FOR ORAL LIQUID
GENERAL CONSIDERATION
Reporting responsibility
Personal requirements
Space requirements
Review of formula
Raw materials
Relevant processing equipments
Process evaluation
GMP consideration
Assurance
PILOT PLANT SCALE UP FOR SUSPENSION
PILOT PLANT SCALE UP FOR EMULSION
REFERENCES
Different types of dosage forms have different properties so according to their handling and storage conditions we have to select containers accordingly
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
This presentation explores a brief idea about the structural and functional attributes of nucleotides, the structure and function of genetic materials along with the impact of UV rays and pH upon them.
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields.
I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
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Exposé invité Journées Nationales du GDR GPL 2024
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.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Salas, V. (2024) "John of St. Thomas (Poinsot) on the Science of Sacred Theol...Studia Poinsotiana
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VI Theology as a Natural Science
VII Theology’s Certitude
VIII Conclusion
Notes
Bibliography
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Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
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Toxic effects of heavy metals : Lead and Arsenicsanjana502982
Heavy metals are naturally occuring metallic chemical elements that have relatively high density, and are toxic at even low concentrations. All toxic metals are termed as heavy metals irrespective of their atomic mass and density, eg. arsenic, lead, mercury, cadmium, thallium, chromium, etc.
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...Travis Hills MN
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
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
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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
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Formulation of parentral pdf
1. 1
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Solutions
• Suspensions
• Emulsions
• Dry Powders
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Solutions
• Manufacture:
– Dissolving drugs and excipients
– Adjusting the pH
– Sterile filtering
» remove particulates and microorganisms
» prefiltrate in large-scale production to prevent
clogging
» select suitable filter material to avoid absorption loss
– Aseptic filling
» Fill volume should be greater than the exact labeled
dose
– Autoclaving
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Suspensions
–Very difficult to formulate and produce
»Excellent stability: ships without
caking/settling
»Critical rheological properties:
syringeability: from container to syringe
injectability: from syringe to vein
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3. Formulation of parenteral products
• Parenteral Dosage Forms
• Suspensions
–Components
»Active ingredients
» aqueous vehicle
» surfactant for wetting
» Preservatives
» buffers
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Suspensions
–Two basic methods:
» Sterile vehicle & powder aseptic
combination;
» Sterile solutions are combined first and
in situ crystallization
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Emulsions
–Rarely used as parenteral products
»Excellent stability requirement;
» Particle size<1um, homodispersity;
»Very limited selection of stabilizers &
emulsifiers;
2. 2
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Emulsions
–w/o, allergy test, SB
– o/w, sustained-release, depot, IM
– o/w, nutrient emulsion, IV
» o/w type, use triglycerides as central
core, phospholipid as emulsifier, to
provide essential fatty acids and calories
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Dry Powders
– Purpose: To overcome the intrinsic
instability of the drug, be reconstituted
before use.
• Production Method:
– Freeze-drying
–Aseptic crystallization and dry powder
filling
– Spray-drying
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Freeze-drying
– Advantages
» Avoid damage to heat-sensitive drugs
» High specific surface are facilitating complete
rehydration
» Improvement in filling accuracy
– Disadvantages:
» Protective agents needed
» Stability changing, crystalline/amorphous
» High-cost and complicated
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Freeze-drying: Under low pressure, under the
triple point of water, water was removed by
sublimation.
• sublimation : ice vapor directly
• Triple point of water : three phases coexisting
in equilibrium
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• Process of freeze-drying
• Freezing
• Primary drying
• Secondary drying
• Capping
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Aseptic crystallization
– The drug is dissolved in a suitable solvent
– Sterile filtered
– A second solvent is then added
– Crystallization and precipitation of the drug
– Collected and washed
– Dried by vacuum drying
– Milled and blended
– Filled into vials
3. 3
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Limitations of aseptic crystallization
–Batch-to batch variance
–Hard to maintain asepsis
– Fill weight uniformity
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Spray-drying
– A solution of drug is sterile filtered
– An aerosol of small droplets of liquid is created by
an atomizer
– Solvent evaporates quickly by contacting with a
stream of hot sterile gas
– Drug is collected as a powder in the form of
uniform hollow spheres
– Filled into vials
Shanghai Jiao Tong University
3. Formulation of parenteral products
• Parenteral Dosage Forms
• Limitations of spray-drying
– Sterile filtration of very large volumes of air
–Constructing and maintaining a spray dryer
that can be readily sterilized
–Aseptic transfer of powder from the spray
dryer to the powder-filling line
– precise control of the drying conditions to
prevent overheating of the product
Shanghai Jiao Tong University
4. Packaging
• Container components for parenteral
products must be considered an integral
part of the product because they can
dramatically affect product stability,
potency, toxicity, and safety.
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Ampoules
• Glass vials sealed with rubber stoppers
• Plastic ampoules (blow-fill-seal)
• Pre-filled syringes
• Needle-free injection
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Ampoules
– heat sealed after filling
4. 4
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Glass vials sealed with rubber stoppers
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Plastic ampoules (blow-fill-seal)
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Pre-filled syringes
– reducing the degree of manipulation required
– facilitating administration in an emergency situation
Shanghai Jiao Tong University
4. Packaging
• Small volume parenterals (SVPs)
• Needle-free injection
Shanghai Jiao Tong University
4. Packaging
• Large volume parenterals (LVPs)
• Glass bottles sealed with rubber stoppers
• Plastic bags
Shanghai Jiao Tong University
4. Packaging
• Single-dose container
• A hermetic container holding a quantity of
sterile drug intended for parenteral
administration as a single dose; when opened,
it cannot be resealed with assurance that
sterility has been maintained.
• Multi-dose container
• A hermetic container that permits withdrawal
of successive portions of the contents without
changing the strength, quality, or purity of the
remaining portion.
5. 5
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5. Stability
• 90% to 95% activity of medicament
• Other considerations
• Adsorption of preservative to a rubber closure
• Physical stability
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6. Sterilization methods
• Sterilization means destruction of all living
organisms and their spores or their
complete removal from the preparation.
Shanghai Jiao Tong University
6. Sterilization methods
• Steam
• Dry heat
• Filtration
• Gas
Shanghai Jiao Tong University
6. Sterilization methods
• Steam
• Steam sterilization is conducted in an
autoclave and employs steam under
pressure.
• This method is preferred to other
sterilization methods if the product and
container can withstand it.
Autoclave Shanghai Jiao Tong University
6. Sterilization methods
• Steam
• The usual temperature and the
approximate length of time required is
121oC for 15 to 30 minutes, depending
on the penetration time of moist heat into
the load.
6. 6
Shanghai Jiao Tong University
6. Sterilization methods
• Dry heat
• The transfer of energy from dry air to the
object that is sterilized. The transfer
occurs through conduction, convection
and radiation.
Shanghai Jiao Tong University
6. Sterilization methods
• Dry heat
• Less effective heat transfer than for
steam sterilization
• Higher temperature and longer time are
required
– 160oC for more than 2 hours
Shanghai Jiao Tong University
6. Sterilization methods
• Dry heat
• Substances that are not effectively
sterilized by steam
• Glassware and surgical instruments
Shanghai Jiao Tong University
6. Sterilization methods
• Filtration
• Sterilization by filtration depends on the
physical removal of microorganisms by
adsorption on the filter medium or by a
sieving mechanism.
• For heat-sensitive solutions
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6. Sterilization methods
• Filtration
• Depth filters
•Membrane filters
(0.22 μm)
Shanghai Jiao Tong University
6. Sterilization methods
• Filtration
• The filtration process might be affected
by adsorption.
• The integrity of the filters has to be
proven
• Avoid filters that cause particles
• Test the filters so that they do not give
extractable
7. 7
Shanghai Jiao Tong University
6. Sterilization methods
• Gas
• Ethylene oxide (ETO) is widely used as a
sterilant in hospitals and industry for items that
cannot be sterilized by steam.
• It is often diluted with carbon dioxide, or
sometimes fluorocarbons, to overcome its
flammable and explosive nature.
• Post treat procedure: to remove the residual
ETO and its byproducts
Shanghai Jiao Tong University
6. Sterilization methods
• Validation of sterility
• Regardless of the method,
pharmaceutical preparations required to
be sterile must undergo tests to confirm
the absence of microorganisms.
Shanghai Jiao Tong University
6. Sterilization methods
• Validation of sterility
• Biological indicator
• F0 value
Shanghai Jiao Tong University
6. Sterilization methods
• Validation of sterility
• Biologic indicator
–A characterized preparation of specific
microorganisms resistant to a particular
sterilization process.
–Added to the product or strips of filter paper
Shanghai Jiao Tong University
6. Sterilization methods
• Validation of sterility
• F0 =D121(logN0-logNt)
–D121 is the time required for a one-log
reduction in the microbial population
exposed to a temperature of 121oC
–N0 is the initial microbial population
–Nt is the final microbial population after
sterilization
Shanghai Jiao Tong University
7. Quality assurance
• Core meaning: To build the quality into the product
• Especially significant for parenteral products, sterility,
absence of pyrogens, freedom from extraneous
particles
• Testing of raw materials, packaging components, and
final product
• Written operating procedures, personnel training, record
keeping, and facility design and monitoring
8. 8
Shanghai Jiao Tong University
7. Quality assurance
• Regulatory and Compendial Requirements
• GMP: Good Manufacturing Practice
– Organization and personnel
– Buildings and facilities
– Control of drug components, packaging, and
materials
– Production and process control
– Equipment
– Packaging and labeling control
– Holding and distribution
– Laboratory control
– Records and reports
Shanghai Jiao Tong University
7. Quality assurance
• Monitoring Programs
• Process facilities
• Production areas
• Personnel
• Environmental monitoring
Shanghai Jiao Tong University
7. Quality assurance
• Product testing and evaluation
• Sterility testing
• Pyrogen testing
• Leaker testing
• Clarity testing and particulate analysis
• Labeling
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7. Quality assurance
• Product testing and evaluation
• Sterility testing
–Direct method : culture tube
–Indirect method: membrane
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7. Quality assurance
• Product testing and evaluation
• Pyrogen test
–Rabbit test
–Limulus amebocyte lysate (LAL) test
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7. Quality assurance
• Product testing and evaluation
• Leaker testing
– For sealed ampoules
» under vacuum, dying method
» ordinary pressure, high-frequency spark
test
9. 9
Shanghai Jiao Tong University
7. Quality assurance
• Product testing and evaluation
• Clarity testing and particulate analysis
– Clarity: the state of quality of being clear or
transparent to the eyes
– Particulate matter: extraneous, mobile, undissolved
substances unintentionally present in parenteral
solutions
Shanghai Jiao Tong University
7. Quality assurance
• Product testing and evaluation
• Labeling
– The drug substance
– Concentration/dose,
– Handling/storage condition
– Any special precautions.
Shanghai Jiao Tong University Learning objectives
• Concepts: Parenteral, WFI, GMP, LVP, SMP,
pyrogen, Freeze-drying (lyophilization) ,
Sterilization
• Routes of parenteral administration
• Functions of the added substances
• Calculation of tonicity adjustment
• Parenteral dosage forms
• Sterilization methods