Technology transfer is important for successful progress of drug development from research to commercialization. This presentation discusses technology transfer from research and development to pilot plant and full-scale production of non-sterile semisolids. It covers the importance of pilot plants in scale-up, factors to consider in scaling up semisolids like mixing equipment and homogenization processes. SUPAC guidelines for scale-up and post-approval changes are also summarized. A case study demonstrates issues encountered like congealing during scale-up of a cream formulation containing diethylene glycol monoethyl ether from lab to pilot scale.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
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.
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
pilot plant is a small system which is operated to find out about the behavior of a process before using it on a large industrial scale. so, this presentation tries to illustrate its objective and significance to understand the methodologies of various pharmaceutical dosage forms.
Pilot plant scaleup techniques | unit 1 | Industrial pharmacyFirst name Last name
General considerations-including
significance of personnel requirements, space requirements, raw materials,Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation,
SUPAC guidelines,Introduction to platform technology
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.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
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
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
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/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
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www.agostodourado.com
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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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...
Technology Transfer From R and D to Pilot Plant to Plant for Non-Sterile Semisolids
1. Technology Transfer From R and D to Pilot Plant to
Plant for Non-Sterile Semisolids
Presented By: Guided By:
Mr. Shivshankar k chandapure Dr.Mr.Avinash R Tekade
M.pharm (semester-I) ( Professor & HOD Of
….Pharmaceutics Pharmaceutics)
Marathwada Mitra Mandal's College of
Pharmacy
2. Contents
Introduction to technology transfer
Importance of technology transfer
Pilot plant
Scale up of semisolid
SUPAC guidelines
Case study
References
3. Technology transfer
Introduction:
A process of successful progress from drug
discovery to product development,
clinical trials and finally to full scale
commercialization.
Technology transfer is helpful to develop
dosage forms in various ways as it
provides efficiency in process, maintains
quality of product, helps to achieve
standardized process which facilitates
4. Importance of technology transfer in
pharmaceutical industry
To elucidate necessary information to transfer
technology from R and D to actual manufacturing.
It provide an opportunity to reduce cost on drug
discovery and development.
It maintain quality of product and achieve
standardization process.
Documented evidence of manufacturing process for drug
product.
Technology transfer includes not only the patentable
aspects of production but also includes the business
processes, such as knowledge and skills.
5. Reasons for technology transfer
Lack of manufacturing capacity.
Lack of resources
Lack of marketing and distribution
capability
Exploitation in a different field of
application:
6.
7. Pilot plant
A pilot plant can be defined as the pre-commercial
production system which includes new production
technology and produces small volumes of new technology-
based products.
Pilot plant includes following:
Development,
Early development activities,
Clinical supply manufacture,
Technology evaluation
Scale up and Transfer to production site
8. Pilot plant scale up activities
The major activities takes place during scale up in early
development phase are;
Technical aspects of process development,
Technical aspects of scale up
Organisation-Organisation responsibility
Determination of responsibility of technology transfer
team.
Technology transfer documentation.
FDA pre-approval inspection preparation.
9. Objectives of scale up
Avoidance of the problems associated with the
scale-up.
Production and process controls guidelines
preparation.
To identify the critical features of the process
Preparation and providing of Master
Manufacturing Formula for manufacturing.
Evaluation and Validation for process and
equipment.
Examination of the formula to assess the batch
stability.
10. Significance of scale up
Standardization of formulae.
Review of range of relevant processing
equipment.
Optimization and control of production rate.
Information on infrastructure of equipment
during the scale up batches.
Information of batches physical space required
for equipment.
Identification of critical features to maintain
quality of a product.
Appropriate records and reports to support
12. The following parameters are to be considered
during the scale up of semisolid products;
Mixing speed.
Mixing equipment (Could be able to move
semisolid mass from outside walls to the centre
and from bottom to top of the kettle).
Motors (Drive mixing system with appropriate
handling system at its most viscous stage).
Heating and cooling process.
Component homogenization.
Manufacturing of Semisolids
13. Product transfer.
Addition of active ingredients.
Working temperature range.
Shear during handling and transfer from
manufacturing to holding tank to filling lines.
Transfer pumps (Easily must move viscous
material without applying excessive shear and
free of entrapped air).
Packaging and storage
14. Mixing equipment
Planetary mixer has great function of
blending, shearing and dispersing, which
suits well in dispersing and blending of
materials in solid to solid, solid to liquid,
liquid to liquid. Planetary mixer is widely
used in chemical, food processing, drug
producing, construction materials and
light industries.
15. Homogenization process
Homogenization is the process of
converting non-uniform mixture
to a colloidal state or a uniform
mixture. It is done by reducing
particle size of mixtures or
uniform dispersion of the
mixtures making the product
homogenous..
16. Colloidal mill
A colloid mill is a machine that
is used to reduce the particle
size of a solid in suspension in
a liquid, or to reduce the
droplet size in emulsions.
Colloid mills work on the rotor-
stator principle: a rotor turns at
high speeds
18. SUPAC GUIDLINES
(scale up post approved changes)
SUPAC represents the changes recommended by the US
FDA at the time of scale up or approval of NDA / ANDA.
In the process of developing a new drug product, the
batch sizes used in the earliest human studies are small
and the size of the batches is gradually increased (Scale-
up).
The scale-up process and the changes made after approval
in the composition, manufacturing
Process, manufacturing equipment, and change of site
have become known as Scale-Up and Post approval
Changes, or SUPAC.
19. SUPAC guidline defines
The level of changes – Minor, Moderate and
Major Changes.
Test – Application test, in vitro dissolution and
in vivo
Filing – Annual report, changes being effected
supplement and Prior Approval Supplement.
The level of changes may impact on formulation
and quality performance in following levels;
Level 1: unlikely to have detectable Impact.
Level 2: could have significant impact.
20. These guidelines provide recommendations for
post approval changes in;
The components or composition change,
The site of manufacture change,
The scale-up of manufacture change
The manufacturing (process and equipment)
change.
21. Scale-Up of an Oil/Water Cream
Containing 40% Diethylene
Glycol Monoethy Ether
Drug development and industrial pharmacy 26 (1), 71-77, 2000
The purpose of this study was to scale up an oil/water (o/w) cream
formulation containing 40% diethylene glycol monoethyl ether (DGME),
developed via 300-g laboratory batches in a 25-2fractional factorial design, to
7-kg batch sizes in a Brogli-10 homogenizer. The o/w cream was
manufactured via a standard phase-inversion process in the Brogli-10
homogenizer. Partitioning studies of DGME were conducted in test tubes at
ambient temperature and after 24 hr at 70°C in a convection oven.
Phase height was measured by vernier calipers. Microscopy studies of
excipients with and without treatment with water or a DGME/water mixture
were conducted with a Nikon microscope after equilibration at 35°C for 24 hr.
During creation of the 7-kg pilot-scale batches, congealed material was
observed between the sweep agitation blade and the discharge port, where
the Brogli-10 homogenizer is not temperature jacketed.
22. Factors that increased the amount of congealed material were higher
temperatures during primary emulsification and longer cooling times.
Partitioning studies revealed that DGME resides in the aqueous external
phase of this formulation.
Microscopy studies revealed that DGME in the external phase of this cream
has a profound impact on the solubility of certain solid, waxy excipients
(e.g., cetyl alcohol and polyoxyethylene-2-stearyl ether) at 35°C. From this
study, it appears that DGME resides in the external phase of the o/w cream.
During manufacturing, it is hypothesized that the presence of DGME in the
external phase alters the solubility of certain solid, waxy excipients in the
formula such that they no longer primarily reside in the internal oil phase.
On cooling, these materials precipitate or congeal in the external phase. The
fractional factorial experimental design at the 300-g laboratory scale did not
predict the issues encountered during scale-up. Differences between
laboratory scale and pilot plant scale that explain why this phenomenon was
not seen during laboratory scale are differences in cooling times,
nonjacketed or “cold spots” in the Brogli-10 homogenizer, and a low
proportion of congealed material in relation to the total batch size (<1.5%).
23. References
1) Leon Lachman,Herbert A.Liberman,:Industerial
pharmacy.Special Indian edition 2009 page no.681
2) Michael Levin,Pharmaceutical process scale up ,Second
edition ,volume 157
3) Roop K Khar, Farhan J Ahmad, A Vashishtha, S. Harder, GV
Buskirk, JV Battista. PilotPlant Scale-up and Production
Management. In: Roop K Khar, SP Vyas, Farhan J Ahmad,
Gaurav K Jain, Editors. Industrial Pharmacy. 4th edition. New
Delhi: CBS Publishers & Distributors Pvt Ltd, 2013. pp. 947-
1002.
24. 4) Dhobale AV, Mahale AM, Shirsat M, Pethkar S,
Chakote V. Recent Advances in Pilot Plant Scale Up
Techniques - A Review. Indo Am J Pharm Res 2018;
8(4): 1060-1068.
5) Mounica NVN, Sharmila RV, Anusha S, Evangeline
L, Nagabhushanam MV,Nagarjunareddy D, et al.
Scale up and Postapproval changes (SUPAC)
Guidance for Industry: A Regulatory note. Int J Drug
RegulAff 2017; 5(1): 13-19.
6)Shayne Cox Gad, Pharmaceutical Manufacturing
Handbook ,Publisher ;A John Wiley and Sons ;67-80.