This document discusses scale up considerations for semi-solid manufacturing. It begins by defining semi-solid dosage forms as ointments, pastes, creams, emulsions, gels and foams that cling to the skin. The raw materials can include hydrocarbons, silicones, oils and water-based ingredients. Key unit operations include addition of components, heating, mixing, homogenization and filling. Process parameters like temperature, mixing rates and particle size must be controlled during scale up. Proper plant layout and equipment selection is also important for effective semi-solid manufacturing.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
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
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
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
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
This presentation includes the detail information about the physics of tablet compression and compaction, Compression, Effect of friction, distribution of forces, compaction profiles,solubility.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
Penetration Enhancers in Transdermal Drug Delivery SystemSimranDhiman12
Penetration Enhancers in Transdermal Drug Delivery System
Permeation enhancers are substances that reduce the skin barrier's ability to make skin more permeable and allow drug molecules to cross the skin at a faster rate
advantages and disadvantages
types of penetration enhancers
techniques
physical and chemical enhancers
This presentation includes the detail information about the physics of tablet compression and compaction, Compression, Effect of friction, distribution of forces, compaction profiles,solubility.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
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Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
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is the oldest recreational drug and likely contributes to more morbidity,
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5th edition of the Diagnostic and Statistical Manual of Mental Disorders
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and severe subclassifications (American Psychiatric Association, 2013).
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Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
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2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
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Study Resources:
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2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
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Prix Galien International 2024 Forum ProgramLevi Shapiro
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
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Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
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Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
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New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
Parag semisolid
1. Scale up for Semi-solid manufacturing
1
Guided by:
Dr. Mahalaxmi Rathnanand
Associate Professor
Department of Pharmaceutics
MCOPS
Manipal Academy of Higher Education
Presented by:
PARAG RAJ BEHURA
Reg. No :190617006
M.Pharm (Industrial Pharmacy)
Department of Pharmaceutics
MCOPS
Manipal Academy of Higher Education
3. What is Semisolid dosage form ?
• Pharmaceutical semisolid preparation include ointments, pastes, cream emulsion,
gels and rigid foams .
• Their common property is the ability to cling to the surface of skin application for
reasonable duration before they are washed or worn off .
• This adhesion is due to their plastic rheological behavior, which allows the
semisolid to retain their shape and cling as a film until acted upon by an outside
force, in which case they deform and flow.
3
4. Raw materials
• The raw material range from hydrocarbons, silicon oil to water (or water miscible) bases. In addition,
insoluble ingredients are also present. Approved and validated actives and excipients are used in the
formulations. Alternative supplies of raw materials and changes in the specifications for the performance
and stability is attempted through several batches of scale up .
• Aqueous phase and oil phase are heated to a temperature above the solidification phase of oil. When waxes
are used, their uniform dispersion needs heating of the liquid phase above solidification phase of wax. In
case of emulsion type semisolids, oil and water phases are homogenized at a predetermined temperature.
The working temperature range is critical .
• Once the equipment is selected, some of the critical parameters are evaluated. Heat transfer characteristics
and temperature gradient throughout the system are important. Temperature control is essential during the
critical emulsification stage. The critical processing conditions are listed.
4
6. • The individual phases or slurries are added in a sequence achieving intermittent mixing .
Scale up parameters:-
Order of addition
Rate of addition.
Heating of phase
6
Addition of Components
7. • Temperature need to be recorded and monitored. The improper control of
temperature can have several adverse effects .
Scale up parameters:-
Temperature control
Time required to increase temperature (650C)
Time required to achieve batch cool down (650C-350C)
Equipment used: - Steam jacketed kettle
7
Heating
9. • Mixing rate, intensity and mixing time are critical factors. The Product needs to be less viscous during
manufacture, so that mixing of ingredient can be effective. Therefore, heating facilities are necessary.
• Changes in viscosity also need to be understood, in terms of conditions such as processing history of the
sample and age of the sample .
• The mixing equipment used should be able to effectively and continuously move the semisolid mass
from the outside walls to the Centre and from bottom to the top of the kettle. This action distributes the
ingredients and helps in rapid & efficient heat transfer to and from the product during the heating and
cooling process.
• Motors used to drive the mixing system should be sized to handle the product at its most viscous stage, as
the power required to carry out the mixing is directly related to the viscosity of the product.
9
Mixing
10. On a small scale : Mixing may be conducted in a porcelain dish or glass beaker an
electronic mortar and pestle .
On a large scale: It is carried out in large steam jacketed kettles
Scale up parameters:-
• Mixing rate
• Time and Pressure
• Temperature
Equipment: - Kettle and tank fitted with agitator, Blade mixture and tumbler
IPQC: - pH, Viscosity, content uniformity, Potency
10
11. • Particle size distribution of poorly soluble active ingredient is essential. This is controlled by choosing
appropriate clearance between stator and rotor.
• The heat produced during the milling is reduced by circulation of cold water through the jacket. At high
temperatures, the drug is solubilized leading to formation of metastable product.
• While other locations, drug may be crystallized. The crystallized product may be a different polymorphic
form or a different crystal type or size. Thus, the finished product characteristics may change.
Example of such changes are particle size distribution, loss of elegancy, altered stability and biological
activity.
11
Homogenisation
12. Scale up Parameters:-
• Elevated temperature
• Cooling temperature
• Clearance between stator and rotor
• Particle size
Equipment: - end-runner mill, hammer mill, ball mill, colloid mill,
micronizer.
IPQC: - Particle size analysis, Density and flow rate of solid.
12
13. • The finished product are transferred from the kettle to holding tanks. The contents are stirred throughout
this stage in order to maintain product uniformity .
• The following critical aspects must be evaluated and controlled during large-scale validation and
manufacturing runs
Scale up parameters
Elevated temperature
Stirring rate
Pumping rate
Equipment: - Kettle and holding tanks
IPQC:- Viscosity , pH , appearance
13
Filling and Packing
15. Conclusion
• Semi solid dosage form can be designed and in depth problems occurring
in various steps must be controlled.
• To prepare a successful product batch studies and testing should be done in
a broad level.
• Extensive future research studies should be conducted for more precise and
accurate product.
15
16. References
• Industrial pharmacy : CVS Subrahmanyam J Thimmasetty : Chapter 7 : page no. 402- 404
• Pharmaceutical process validation: An international third edition , revised and expanded :
Introduction of semisolid : page no. 22-24
• The Theory and Practice of Industrial Pharmacy : Leon Lachman , Herbert A Lieberman ,
Joseph L Kanig : Section III : Chapter 18 :pharmaceutical dosage form : page no. 534.
• Dr. A.K. Seth; Pharmaceutics-II (Dispensing and Formulation); S. Vikas and Co. publishing
house; 262-319
• The Theory and Practice of Industrial Pharmacy; 3 rd edition; Varghese publication; 534-563
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17. • http://saspublisher.com/wpcontent/uploads/2014/03/SAJP32-153-161.pdf
• Patel P, Tyagi S, Patel CJ, Patel J, Chaudhari B, Kumar U: Recent advances in novel semisolid
dosage forms: An overview. Journal of biomedical and pharmaceutical research 2013; 2(1):9-
14.
• Mithilesh, S. (2020). [online] Available at:
• http://www.pharmainfo.net/free-books/novel-semisolid-dosage-forms
• http://www.pharmainfo.net/evaluation-ointments 47
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