It was an assignment of mine when i was undergraduate, studying at Gono Bishwabidyalay. this assignment contains:
Introduction, Definitions, Unique characteristics, categories, routes, advantages and dis-advantages.
On insulin part i focused on:
Introduction, different formulations of insulin, injectable insulin preparation, methods of insulin preparation, quality control of insulin, quality control parameter, common quality control tests, packaging and packaging materials..
Pharmaceutical Biotechnology Research Presentation : Recombinant Streptokinase
Dr. Godfrey Mazhandu
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
upstream & downstream process of antibioticsAnil Kollur
The document discusses upstream and downstream processing of antibiotics, hormones, and vaccines. Upstream processing involves fermentation and includes inoculum preparation, culture media development, and fermentation. Downstream processing refers to product recovery, purification, and formulation stages after fermentation. These include steps like separation, concentration, purification. The document provides details of these processes for antibiotics like penicillin, hormones, and vaccines.
Upstream & downstream processing of antibiotics,hormones,vaccinesMicrobiology
The document discusses the upstream and downstream processes involved in the production of antibiotics, hormones, and vaccines from microorganisms. Upstream processing involves inoculum preparation, culture media preparation, and fermentation. Downstream processing involves separation, purification, and formulation steps to recover and purify the desired products. These include solid-liquid separation, cell disruption, concentration, and purification techniques like chromatography. The specific upstream and downstream processes for producing penicillin from Penicillium chrysogenum are also outlined.
Penicillin was the first antibiotic to be discovered in 1928 from the fungus Penicillium notatum. It was purified in the 1940s and used widely during World War 2. Industrial production involves growing the fungus Penicillium chrysogenum in large fermenters, extracting and purifying the penicillin. The fermentation process yields about 50 grams of penicillin per cubic meter now compared to 1 milligram previously. Purification involves filtration, extraction into organic solvents like butyl acetate, and crystallization to produce the final product.
1) The study investigated the effects of corn silk extract (CSE) on glycemic metabolism in hyperglycemic mice.
2) CSE treatment significantly reduced blood glucose and HbA1c levels and increased insulin secretion in alloxan-induced hyperglycemic mice.
3) CSE treatment partly recovered damaged pancreatic β-cells in hyperglycemic mice. However, CSE did not inhibit gluconeogenesis or increase hepatic glycogen.
The document discusses the production of the antifungal antibiotic griseofulvin. It describes the fermentation process using the fungus Penicillium griseofulvum to produce griseofulvin. The process involves growing the fungus in a liquid medium, extracting and purifying the griseofulvin through various steps like filtration, precipitation, and crystallization to obtain the final product. Griseofulvin is then used to treat fungal infections like ringworm.
54.Isolation and purification of cellulase from Aspergillus terreusAnnadurai B
This document describes the isolation and purification of cellulase enzymes from the fungus Aspergillus terreus. The intracellular cellulase was purified using ammonium sulfate precipitation, DEAE-cellulose chromatography, and gel filtration chromatography. This purification scheme achieved a 270-fold purification with a 22.11% yield. Tests including PAGE, SDS-PAGE, immunodiffusion, and isoelectric focusing confirmed the homogeneity of the purified enzyme. The purified cellulase showed optimal activity between pH 4-7 and temperatures of 40-50°C.
Pharmaceutical Biotechnology Research Presentation : Recombinant Streptokinase
Dr. Godfrey Mazhandu
Professor Peivand Pirouzi Inc. -
Copyright 2015 - Professor Peivand Pirouzi Inc., International Corporate Training, Canada
All rights reserved
upstream & downstream process of antibioticsAnil Kollur
The document discusses upstream and downstream processing of antibiotics, hormones, and vaccines. Upstream processing involves fermentation and includes inoculum preparation, culture media development, and fermentation. Downstream processing refers to product recovery, purification, and formulation stages after fermentation. These include steps like separation, concentration, purification. The document provides details of these processes for antibiotics like penicillin, hormones, and vaccines.
Upstream & downstream processing of antibiotics,hormones,vaccinesMicrobiology
The document discusses the upstream and downstream processes involved in the production of antibiotics, hormones, and vaccines from microorganisms. Upstream processing involves inoculum preparation, culture media preparation, and fermentation. Downstream processing involves separation, purification, and formulation steps to recover and purify the desired products. These include solid-liquid separation, cell disruption, concentration, and purification techniques like chromatography. The specific upstream and downstream processes for producing penicillin from Penicillium chrysogenum are also outlined.
Penicillin was the first antibiotic to be discovered in 1928 from the fungus Penicillium notatum. It was purified in the 1940s and used widely during World War 2. Industrial production involves growing the fungus Penicillium chrysogenum in large fermenters, extracting and purifying the penicillin. The fermentation process yields about 50 grams of penicillin per cubic meter now compared to 1 milligram previously. Purification involves filtration, extraction into organic solvents like butyl acetate, and crystallization to produce the final product.
1) The study investigated the effects of corn silk extract (CSE) on glycemic metabolism in hyperglycemic mice.
2) CSE treatment significantly reduced blood glucose and HbA1c levels and increased insulin secretion in alloxan-induced hyperglycemic mice.
3) CSE treatment partly recovered damaged pancreatic β-cells in hyperglycemic mice. However, CSE did not inhibit gluconeogenesis or increase hepatic glycogen.
The document discusses the production of the antifungal antibiotic griseofulvin. It describes the fermentation process using the fungus Penicillium griseofulvum to produce griseofulvin. The process involves growing the fungus in a liquid medium, extracting and purifying the griseofulvin through various steps like filtration, precipitation, and crystallization to obtain the final product. Griseofulvin is then used to treat fungal infections like ringworm.
54.Isolation and purification of cellulase from Aspergillus terreusAnnadurai B
This document describes the isolation and purification of cellulase enzymes from the fungus Aspergillus terreus. The intracellular cellulase was purified using ammonium sulfate precipitation, DEAE-cellulose chromatography, and gel filtration chromatography. This purification scheme achieved a 270-fold purification with a 22.11% yield. Tests including PAGE, SDS-PAGE, immunodiffusion, and isoelectric focusing confirmed the homogeneity of the purified enzyme. The purified cellulase showed optimal activity between pH 4-7 and temperatures of 40-50°C.
Extraction and purification of product from fermentation is known as Downstream Processing ( DSP) or Product Recovery
It is an essential step in the manufacture of pharmaceuticals product
Cost of the product is determined by the DSP involved
IJERA (International journal of Engineering Research and Applications) is International online, ... peer reviewed journal. For more detail or submit your article, please visit www.ijera.com
Protein Extraction and Purification of Soybean Flakes and Meals Using a Lime ...IJMER
This document describes a study that investigated extracting and purifying protein from soybean flakes and meals using lime treatment followed by ultrafiltration. Key findings include:
- Soybean flakes and meals were produced from whole soybeans using conventional methods. Flakes had higher protein and carbohydrate extraction than meals after treatments.
- Lime treatment at 0.5 moles resulted in the highest extraction of total dissolved solids (TDS) from both flakes and meals, compared to water, NaOH, or other lime concentrations.
- Ultrafiltration purified the protein extracts from flakes and meals with 94-97% protein yield and removal of carbohydrates through diafiltration.
- Lime treatment is a potential
Enzymes are biological catalysts that speed up biochemical reactions. They are used in many industrial applications such as food processing, detergents, and biofuel production. Enzymes have several advantages over inorganic catalysts such as high specificity and ability to function under mild conditions. In food processing, enzymes are used in dairy, meat, baking, and brewing. Common enzymes include amylases, proteases, lipases, and pectinases. The paper, biofuel, and brewing industries also utilize enzymes like cellulases, xylanases, and amylases. Overall, enzymes are valuable biocatalysts with many applications in biotechnology due to their specificity and efficiency.
Chitinase is an enzyme that degrades chitin, a polysaccharide found in fungal cell walls and crustacean exoskeletons. Microbes like Serratia marceance, Stenotrophomonas maltophilia, Saccharomyces cerevisiae, and Trichoderma spp can produce chitinase. Upstream processing for chitinase production involves inoculum development using stock cultures and fermentation using media containing chitin, yeast extract, and phosphate buffers. Downstream processing separates and purifies chitinase from fermentation broth using centrifugation, precipitation with ammonium sulfate, ion exchange chromatography, and crystallization. Purified chit
It's probiotics: encapsulation and isolationsaisankar21
The document discusses characterization and encapsulation of probiotic Lactobacillus cells isolated from fermented curd. The objectives were to isolate probiotic Lactobacillus from curd, encapsulate the cells using sodium alginate and whey powder, and evaluate their survival under simulated gastrointestinal conditions. Various tests were conducted to characterize the isolates including resistance to bile salts and low pH. Selected isolates were encapsulated via extrusion and their survival in simulated gastric and intestinal fluids was examined over time. Encapsulation yields up to 87.5% were obtained. Scanning electron microscopy confirmed the presence of bacterial cells within the capsules.
1) Peptic ulcer occurs in the stomach and duodenum where gastric acid and pepsin are present.
2) Factors like H. pylori infection, psychosomatic issues, and vascular or humoral imbalances can contribute to ulcer formation.
3) Treatment includes H2 antagonists, proton pump inhibitors, and anti-H. pylori drugs to relieve symptoms, promote healing, and prevent recurrence.
Steroids are compounds containing a cyclic steroid nucleus. They include mineralocorticoids like aldosterone, glucocorticoids like cortisol, and sex hormones. Glucocorticoids have effects on metabolism, inflammation, immunity, and more. They are used to treat conditions like inflammatory bowel disease. Long term steroid use can suppress the HPA axis and cause adverse effects, so tapering is important. During stress and surgery, steroids may need to be increased or supplemented to avoid adrenal insufficiency.
This document discusses microencapsulation of probiotic bacteria. It begins by defining probiotics and their health benefits. Microencapsulation techniques can protect probiotic bacteria from harsh environments and target delivery to the gut. Common encapsulation methods include spray drying, extrusion and emulsion. Materials used for encapsulation include sodium alginate, cellulose acetate phthalate, chitosan and starch. Microencapsulation has applications in food and pharmaceutical products to enhance the viability of probiotic bacteria.
High pressure processing (HPP) is a method of preserving and sterilizing food, in which a product is processed under very high pressure, leading to the inactivation of certain microorganisms and enzymes in the food
This document discusses various proteins and enzymes used as pharmaceutical aids. It describes gelatin, casein, papain, bromelain, pepsin, urokinase, streptokinase, and serratiopeptidase. Gelatin is extracted from animal collagen and used in capsules and suppositories. Casein is the main protein in milk and used as an emulsifier. Papain from papaya, bromelain from pineapple, and pepsin from hog stomach are digestive enzymes. Urokinase from urine and streptokinase from bacteria are fibrinolytic enzymes. Serratiopeptidase from silk moth larvae is an anti-inflammatory enzyme. These naturally derived proteins and enzymes have various pharmaceutical
Hpp Tolling technology shelf life and food safety presentation 2015Christopher Droney
HPP Tolling is an Irish based company that offers the 700+ food and beverage production companies in Ireland the opportunity to use our HPP Technology to extend the shelf life and safety of their food, while eliminates all the bacteria’s in their products such as Salmonella, Listeria and e coli. The technology works by applying tremendously high levels of pressure through the medium of water to the already packaged food products after they have been placed in a high pressure chamber for treatment.
Isolation and purification of peroxidase from soyabeanPooja Walke
Peroxidase (EC. 1.11.1.7), an oxidoreductase, has iron porphyrin ring generally and catalyzes a redox reaction between H202 as an electron acceptor and many kinds of substrates by means of oxygen liberation from HzOz (Brill, 1996).
This document provides an overview of parenteral dosage forms, including definitions, advantages and disadvantages, preformulation considerations, and types of small and large volume parenterals. Parenterals refer to routes of administration other than the gastrointestinal tract, such as intravenous, intramuscular, and subcutaneous. Preformulation studies examine the drug's physicochemical properties, solubility, stability, and compatibility with excipients. Small volume parenterals are formulated with water for injection, buffers, antimicrobial preservatives, antioxidants, tonicity agents, and surfactants. Large volume parenterals provide intravenous nutrition through protein, energy, electrolyte, and vitamin substrates. Finished products are tested for content uniformity, leakage,
The ameliorative potential of hyphaene thebaica on streptozotocin induced dia...Prof. Hesham N. Mustafa
Background: Diabetic nephropathy (DN) is the leading cause of end-stage renal
disease. The aim of the current study is to investigate the possible beneficial effects
of Hyphaene thebaica in DN.
Materials and methods: For this, 50 male albino rats were divided into five
groups: group I — represented the control group; group II — received Hyphaene thebaica extracts of 150 mg/kg BW by oral gavage for 6 weeks; group III
— received single intraperitoneal injections of streptozotocin (50 mg/kg BW)
to induce type-2 diabetes mellitus; group IV (protective) — diabetic rats received Hyphaene thebaica extract (150 mg/kg BW) orally for 6 weeks; group V
(curative) — received Hyphaene thebaica extract (150 mg/kg BW) orally after the
diagnosis of DN.
Results: In the DN protected group, blood glucose, urea, and creatinine decreased
significantly, while insulin and C-peptide increased significantly. Moreover, cystatin C
and neutrophil gelatinase-associated lipocalin decreased. Collagen fibre deposition is increased with an apparent thickening of the parietal layer of Bowman’s
capsules and the basal lamina of convoluted tubules, as well as increase of the
immune-reaction of caspase-3 and desmin. The introduction of Hyphaene thebaica
led to greater amelioration in the biochemical markers, apoptotic alterations, and
podocyte injuries of the protected group than in the curative group.
Conclusions: Hyphaene thebaica may be advised as a good choice that can delay
diabetic renal complications. (Folia Morphol 2015; 74, 4: 447–457)
Key words: diabetic nephropathy, Hyphaene thebaica, podocyte injury,
apoptosis
Industrial fermentation involves two main stages: upstream processing (USP) and downstream processing (DSP). USP includes obtaining a suitable microorganism, strain improvement, media preparation, and the fermentation process. DSP follows fermentation and includes cell harvesting, disruption, and product purification. Common downstream processing unit operations include centrifugation, precipitation, ultrafiltration, and chromatography. The level of purification required depends on the intended use of the enzyme or protein.
This document discusses microbial enzymes and their applications. It describes the different types of enzymes produced by microbes, including hydrolases, oxidoreductases, lyases and isomerases. Specific microbial enzymes are discussed in detail, including amylases, proteases, pectinases, and glucose isomerase. The document outlines the industrial applications of these enzymes and describes the microbial production processes through fermentation. Key aspects like strain selection, nutrient media optimization, and downstream processing methods are summarized.
This document summarizes the fermentation process for producing the antifungal drug griseofulvin. It involves fermenting the fungus Penicillium griseofulvum in a liquid medium, then extracting, purifying, and precipitating the active compound griseofulvin. Key steps include pre-treating the fermentation broth, filtration to remove fungal matter, extraction of griseofulvin using acetone, decolorization with calcium hydroxide, and final precipitation and purification of purified griseofulvin crystals by addition of a non-solvent like water. The goal is to produce pure pharmaceutical-grade griseofulvin through this multi-step fermentation and purification
This document provides an overview of high pressure processing (HPP) of foods. HPP uses high pressure, around 400-600 MPa, to inactivate pathogens and microorganisms while minimally affecting the food's qualities. HPP retains food quality by preserving nutrients, texture, taste and appearance. It has applications for foods like meats, seafood, juices, sauces, dairy products and more. The advantages of HPP are that it achieves uniform microbial reduction without heat, maintains sensory qualities and is more environmentally friendly than thermal processing. The document discusses the basic principles, history, equipment, generation of pressure, applications and advantages and disadvantages of HPP.
The 1st recombinant drug .
A protein chain or peptide hormone.
A dimer of an A-chain & a B-chain linked together by disulfide bonds, composed of 110 aa & molecular mass is 5808 Da.
A product of commercially important fermentation process that produce recombinant products.
Naturally produced by beta cells of the islets of Langerhans in the pancreas & by Brockmann body in some teleost fish.
The preproinsulin precursor of insulin is encoded by the INS gene.
Important for metabolism and utilization of energy from the ingested nutrients – especially glucose.
Failure of control of insulin level causes diabetes mellitus.
Insulin bioassay is the measurement of insulin potency by biological activity measurement using a standard biological system. An often used technique is to inject insulin samples into animals, usually rats or rabbits, and then track their blood sugar levels to see how well insulin lowers blood sugar. An alternate strategy is to measure glucose absorption or metabolic reactions using cultured cells sensitive to insulin, including adipocytes or muscle cells. By giving important information on insulin potency, purity, and stability, these tests guarantee the quality of insulin products intended for therapeutic use. Bioassays continue to be necessary for insulin preparation quality control and regulatory clearance even with the development of analytical methods.
Extraction and purification of product from fermentation is known as Downstream Processing ( DSP) or Product Recovery
It is an essential step in the manufacture of pharmaceuticals product
Cost of the product is determined by the DSP involved
IJERA (International journal of Engineering Research and Applications) is International online, ... peer reviewed journal. For more detail or submit your article, please visit www.ijera.com
Protein Extraction and Purification of Soybean Flakes and Meals Using a Lime ...IJMER
This document describes a study that investigated extracting and purifying protein from soybean flakes and meals using lime treatment followed by ultrafiltration. Key findings include:
- Soybean flakes and meals were produced from whole soybeans using conventional methods. Flakes had higher protein and carbohydrate extraction than meals after treatments.
- Lime treatment at 0.5 moles resulted in the highest extraction of total dissolved solids (TDS) from both flakes and meals, compared to water, NaOH, or other lime concentrations.
- Ultrafiltration purified the protein extracts from flakes and meals with 94-97% protein yield and removal of carbohydrates through diafiltration.
- Lime treatment is a potential
Enzymes are biological catalysts that speed up biochemical reactions. They are used in many industrial applications such as food processing, detergents, and biofuel production. Enzymes have several advantages over inorganic catalysts such as high specificity and ability to function under mild conditions. In food processing, enzymes are used in dairy, meat, baking, and brewing. Common enzymes include amylases, proteases, lipases, and pectinases. The paper, biofuel, and brewing industries also utilize enzymes like cellulases, xylanases, and amylases. Overall, enzymes are valuable biocatalysts with many applications in biotechnology due to their specificity and efficiency.
Chitinase is an enzyme that degrades chitin, a polysaccharide found in fungal cell walls and crustacean exoskeletons. Microbes like Serratia marceance, Stenotrophomonas maltophilia, Saccharomyces cerevisiae, and Trichoderma spp can produce chitinase. Upstream processing for chitinase production involves inoculum development using stock cultures and fermentation using media containing chitin, yeast extract, and phosphate buffers. Downstream processing separates and purifies chitinase from fermentation broth using centrifugation, precipitation with ammonium sulfate, ion exchange chromatography, and crystallization. Purified chit
It's probiotics: encapsulation and isolationsaisankar21
The document discusses characterization and encapsulation of probiotic Lactobacillus cells isolated from fermented curd. The objectives were to isolate probiotic Lactobacillus from curd, encapsulate the cells using sodium alginate and whey powder, and evaluate their survival under simulated gastrointestinal conditions. Various tests were conducted to characterize the isolates including resistance to bile salts and low pH. Selected isolates were encapsulated via extrusion and their survival in simulated gastric and intestinal fluids was examined over time. Encapsulation yields up to 87.5% were obtained. Scanning electron microscopy confirmed the presence of bacterial cells within the capsules.
1) Peptic ulcer occurs in the stomach and duodenum where gastric acid and pepsin are present.
2) Factors like H. pylori infection, psychosomatic issues, and vascular or humoral imbalances can contribute to ulcer formation.
3) Treatment includes H2 antagonists, proton pump inhibitors, and anti-H. pylori drugs to relieve symptoms, promote healing, and prevent recurrence.
Steroids are compounds containing a cyclic steroid nucleus. They include mineralocorticoids like aldosterone, glucocorticoids like cortisol, and sex hormones. Glucocorticoids have effects on metabolism, inflammation, immunity, and more. They are used to treat conditions like inflammatory bowel disease. Long term steroid use can suppress the HPA axis and cause adverse effects, so tapering is important. During stress and surgery, steroids may need to be increased or supplemented to avoid adrenal insufficiency.
This document discusses microencapsulation of probiotic bacteria. It begins by defining probiotics and their health benefits. Microencapsulation techniques can protect probiotic bacteria from harsh environments and target delivery to the gut. Common encapsulation methods include spray drying, extrusion and emulsion. Materials used for encapsulation include sodium alginate, cellulose acetate phthalate, chitosan and starch. Microencapsulation has applications in food and pharmaceutical products to enhance the viability of probiotic bacteria.
High pressure processing (HPP) is a method of preserving and sterilizing food, in which a product is processed under very high pressure, leading to the inactivation of certain microorganisms and enzymes in the food
This document discusses various proteins and enzymes used as pharmaceutical aids. It describes gelatin, casein, papain, bromelain, pepsin, urokinase, streptokinase, and serratiopeptidase. Gelatin is extracted from animal collagen and used in capsules and suppositories. Casein is the main protein in milk and used as an emulsifier. Papain from papaya, bromelain from pineapple, and pepsin from hog stomach are digestive enzymes. Urokinase from urine and streptokinase from bacteria are fibrinolytic enzymes. Serratiopeptidase from silk moth larvae is an anti-inflammatory enzyme. These naturally derived proteins and enzymes have various pharmaceutical
Hpp Tolling technology shelf life and food safety presentation 2015Christopher Droney
HPP Tolling is an Irish based company that offers the 700+ food and beverage production companies in Ireland the opportunity to use our HPP Technology to extend the shelf life and safety of their food, while eliminates all the bacteria’s in their products such as Salmonella, Listeria and e coli. The technology works by applying tremendously high levels of pressure through the medium of water to the already packaged food products after they have been placed in a high pressure chamber for treatment.
Isolation and purification of peroxidase from soyabeanPooja Walke
Peroxidase (EC. 1.11.1.7), an oxidoreductase, has iron porphyrin ring generally and catalyzes a redox reaction between H202 as an electron acceptor and many kinds of substrates by means of oxygen liberation from HzOz (Brill, 1996).
This document provides an overview of parenteral dosage forms, including definitions, advantages and disadvantages, preformulation considerations, and types of small and large volume parenterals. Parenterals refer to routes of administration other than the gastrointestinal tract, such as intravenous, intramuscular, and subcutaneous. Preformulation studies examine the drug's physicochemical properties, solubility, stability, and compatibility with excipients. Small volume parenterals are formulated with water for injection, buffers, antimicrobial preservatives, antioxidants, tonicity agents, and surfactants. Large volume parenterals provide intravenous nutrition through protein, energy, electrolyte, and vitamin substrates. Finished products are tested for content uniformity, leakage,
The ameliorative potential of hyphaene thebaica on streptozotocin induced dia...Prof. Hesham N. Mustafa
Background: Diabetic nephropathy (DN) is the leading cause of end-stage renal
disease. The aim of the current study is to investigate the possible beneficial effects
of Hyphaene thebaica in DN.
Materials and methods: For this, 50 male albino rats were divided into five
groups: group I — represented the control group; group II — received Hyphaene thebaica extracts of 150 mg/kg BW by oral gavage for 6 weeks; group III
— received single intraperitoneal injections of streptozotocin (50 mg/kg BW)
to induce type-2 diabetes mellitus; group IV (protective) — diabetic rats received Hyphaene thebaica extract (150 mg/kg BW) orally for 6 weeks; group V
(curative) — received Hyphaene thebaica extract (150 mg/kg BW) orally after the
diagnosis of DN.
Results: In the DN protected group, blood glucose, urea, and creatinine decreased
significantly, while insulin and C-peptide increased significantly. Moreover, cystatin C
and neutrophil gelatinase-associated lipocalin decreased. Collagen fibre deposition is increased with an apparent thickening of the parietal layer of Bowman’s
capsules and the basal lamina of convoluted tubules, as well as increase of the
immune-reaction of caspase-3 and desmin. The introduction of Hyphaene thebaica
led to greater amelioration in the biochemical markers, apoptotic alterations, and
podocyte injuries of the protected group than in the curative group.
Conclusions: Hyphaene thebaica may be advised as a good choice that can delay
diabetic renal complications. (Folia Morphol 2015; 74, 4: 447–457)
Key words: diabetic nephropathy, Hyphaene thebaica, podocyte injury,
apoptosis
Industrial fermentation involves two main stages: upstream processing (USP) and downstream processing (DSP). USP includes obtaining a suitable microorganism, strain improvement, media preparation, and the fermentation process. DSP follows fermentation and includes cell harvesting, disruption, and product purification. Common downstream processing unit operations include centrifugation, precipitation, ultrafiltration, and chromatography. The level of purification required depends on the intended use of the enzyme or protein.
This document discusses microbial enzymes and their applications. It describes the different types of enzymes produced by microbes, including hydrolases, oxidoreductases, lyases and isomerases. Specific microbial enzymes are discussed in detail, including amylases, proteases, pectinases, and glucose isomerase. The document outlines the industrial applications of these enzymes and describes the microbial production processes through fermentation. Key aspects like strain selection, nutrient media optimization, and downstream processing methods are summarized.
This document summarizes the fermentation process for producing the antifungal drug griseofulvin. It involves fermenting the fungus Penicillium griseofulvum in a liquid medium, then extracting, purifying, and precipitating the active compound griseofulvin. Key steps include pre-treating the fermentation broth, filtration to remove fungal matter, extraction of griseofulvin using acetone, decolorization with calcium hydroxide, and final precipitation and purification of purified griseofulvin crystals by addition of a non-solvent like water. The goal is to produce pure pharmaceutical-grade griseofulvin through this multi-step fermentation and purification
This document provides an overview of high pressure processing (HPP) of foods. HPP uses high pressure, around 400-600 MPa, to inactivate pathogens and microorganisms while minimally affecting the food's qualities. HPP retains food quality by preserving nutrients, texture, taste and appearance. It has applications for foods like meats, seafood, juices, sauces, dairy products and more. The advantages of HPP are that it achieves uniform microbial reduction without heat, maintains sensory qualities and is more environmentally friendly than thermal processing. The document discusses the basic principles, history, equipment, generation of pressure, applications and advantages and disadvantages of HPP.
The 1st recombinant drug .
A protein chain or peptide hormone.
A dimer of an A-chain & a B-chain linked together by disulfide bonds, composed of 110 aa & molecular mass is 5808 Da.
A product of commercially important fermentation process that produce recombinant products.
Naturally produced by beta cells of the islets of Langerhans in the pancreas & by Brockmann body in some teleost fish.
The preproinsulin precursor of insulin is encoded by the INS gene.
Important for metabolism and utilization of energy from the ingested nutrients – especially glucose.
Failure of control of insulin level causes diabetes mellitus.
Insulin bioassay is the measurement of insulin potency by biological activity measurement using a standard biological system. An often used technique is to inject insulin samples into animals, usually rats or rabbits, and then track their blood sugar levels to see how well insulin lowers blood sugar. An alternate strategy is to measure glucose absorption or metabolic reactions using cultured cells sensitive to insulin, including adipocytes or muscle cells. By giving important information on insulin potency, purity, and stability, these tests guarantee the quality of insulin products intended for therapeutic use. Bioassays continue to be necessary for insulin preparation quality control and regulatory clearance even with the development of analytical methods.
This document discusses the production of recombinant human insulin. It begins with an introduction to insulin, its structure, pharmacological action, and importance. It then describes how recombinant insulin is produced using genetically engineered bacteria or yeast as host cells. The upstream process involves gene expression and protein production, while the downstream process focuses on purification of the insulin. E. coli and Saccharomyces cerevisiae are discussed as potential host cells, noting advantages and disadvantages of each for insulin production.
1. Insulin is produced through recombinant DNA technology by inserting the human insulin gene into E. coli bacteria.
2. The E. coli are cultured and the inclusion bodies containing proinsulin are isolated through cell disruption and centrifugation.
3. The inclusion bodies are solubilized and undergo sulfitolysis and refolding to produce correctly folded proinsulin.
4. The proinsulin then undergoes site-specific cleavage to produce insulin and C-peptide, which are purified through chromatography.
This document summarizes the process of producing human insulin through recombinant DNA technology using E. coli bacteria. It involves growing E. coli in a bioreactor to produce proinsulin inclusion bodies, isolating the inclusion bodies through centrifugation, solubilizing and refolding the proinsulin, and purifying it through affinity chromatography, site-specific cleavage, reverse phase chromatography, and polishing. The purified human insulin can then be stored at 4°C for pharmaceutical use in diabetes treatment.
This document discusses novel approaches to deliver insulin, including through the oral, pulmonary, buccal, transdermal, nasal, and rectal routes. Nanoparticles using chitosan and Arabic gum are proposed for oral insulin delivery. Insulin nanoparticles are characterized for size, polydispersity, zeta potential, and morphology. Release studies are conducted at different pH levels to evaluate the formulations. Overall, the document reviews various alternative routes and formulations to overcome challenges with subcutaneous insulin injections.
Penicillin and its industrial productionrasikapatil26
This document provides information about the industrial production process of penicillin. It discusses the key stages of upstream and downstream processing. Upstream involves fermentation using Penicillium chrysogenum fungus in a controlled bioreactor with glucose and corn steep liquor media. Downstream includes removing biomass through filtration, extracting penicillin using solvents and buffers, purifying it through centrifugation and extraction, drying the penicillin salt through fluidized bed drying, and storing the final product. The large-scale industrial production of penicillin through fermentation and purification was a major medical breakthrough.
Expt. 8 Hypoglycemic effect of insulin in rabbitVISHALJADHAV100
This experiment aims to evaluate the hypoglycemic effect of insulin in rabbits at different time intervals. Healthy rabbits weighing 1800-3000 grams were fasted for 18 hours before being injected with 1 unit per ml of insulin. Blood glucose levels were measured initially and then every hour for 5 hours post-injection. Insulin caused blood glucose levels to decrease over time, demonstrating its ability to lower blood sugar as it stimulates glucose uptake into cells. The mean percentage decrease in glucose at each interval determined the hypoglycemic potency of insulin over the study period.
Bioassy of insulin according to Indian pharmacopoeiaSONALPANDE5
This document summarizes several methods for bioassaying insulin, including preparation of standard and test solutions, rabbit, mouse, rat diaphragm, and rat epididymal fat pad methods. It also describes the radioimmunoassay method, which uses radiolabeled insulin and antibodies to determine insulin concentration in test samples by comparing to standard curves.
1) The document discusses the production of recombinant insulin, including its history, structure, and production methods.
2) Key events include the discovery of insulin in the 1920s, the development of recombinant DNA techniques allowing production of human insulin in bacteria in 1978, and FDA approval of the first biosynthetic human insulin in 1982.
3) Production involves transforming E. coli with insulin genes, growing the bacteria, isolating inclusion bodies containing insulin precursor, and processing the inclusion bodies to solubilize and purify the insulin.
This document summarizes different bioassay methods used to test the potency of insulin samples, including the rabbit method, mouse method, rat diaphragm method, and epididymal fat pad of rat method. The rabbit method involves measuring changes in blood sugar levels after administering standardized and test insulin doses to groups of rabbits. The mouse method compares the percentage of convulsions produced by standardized and test insulin doses in mice. The rat diaphragm and epididymal fat pad methods examine the effects of insulin on glucose uptake in rat tissue samples.
FORMULATION OF PARENTERAL PRODUCTS REQUIREMENTS, FORMULATION DEVELOPMENT, PRETREATMENT OF WATER ,REVERSE OSMOSIS ,STERILE WATER FOR INJECTION USP ,PYROGENS,
This document discusses the production of human insulin using recombinant DNA technology. It begins by providing background on insulin and diabetes. Insulin is normally produced in the pancreas but some people do not produce enough. Recombinant DNA technology allows for the insertion of the human insulin gene into E. coli bacteria. The bacteria then produce human insulin which can be purified from cell cultures. This was the first pharmaceutical produced using recombinant DNA and was approved for diabetes treatment in 1982 under the name Humulin. The document details the cloning of the insulin gene, production in E. coli, purification downstream processing, and advantages of using this system.
The document discusses the structure, production, and manufacturing of insulin. It describes how insulin is produced naturally in the pancreas and synthesized as proinsulin which is cleaved into active insulin. It then summarizes the development of recombinant human insulin production using genetic engineering techniques, including expressing the insulin gene in E. coli or yeast. The manufacturing process involves growing the engineered bacteria, extracting the fusion proteins, separating and purifying the insulin chains, and adding stabilizing ingredients to produce therapeutic insulin products.
Bioassay of insulin & Bioassay of VasopressinHeena Parveen
This document summarizes bioassay methods for measuring the potency of insulin and vasopressin, including:
- Rabbit and mouse methods that measure the hypoglycemic or convulsive effects of test samples compared to standards.
- Rat diaphragm and fat pad methods measuring insulin's effects on glucose uptake and fat metabolism.
- Radioimmunoassay, a sensitive technique using radiolabeled antigens to quantify insulin concentrations via competitive binding.
- A suggested method for vasopressin involving cannulation of rats to measure changes in blood pressure after administration of test samples versus a reference standard.
This document discusses various therapeutic hormones including insulin, growth hormone, gonadotrophins, thyroid stimulating hormone, parathyroid hormone, and calcitonin. It provides details on their structure, function, production, formulations, and medical applications. Key points include: insulin is produced in the pancreas and regulates blood glucose; growth hormone stimulates growth; gonadotrophins like FSH and LH regulate reproduction; recombinant DNA technology is now used to produce many therapeutic hormones which has improved safety over extracts from animal tissues. These hormones are administered to treat various endocrine disorders and fertility issues.
This document provides an overview of insulin, including its discovery in 1921, types, how it works, methods of delivery, and current products. Insulin is a polypeptide hormone produced in the pancreas that regulates glucose levels. There are two main types of diabetes based on insulin levels and production. Insulin is delivered through various methods including insulin pens, pumps, patches, inhalers, and pills which are still in development. The document reviews the actions of insulin and preparations from different animal sources before discussing current marketed insulin products and mixtures.
This document describes several bioassay methods for measuring the potency of insulin samples, including rabbit, mouse, rat diaphragm, and rat epididymal fat pad methods. For the rabbit method, insulin samples and a standard are injected subcutaneously in rabbits and blood sugar levels are measured over time, comparing the hypoglycemic effect between samples. The mouse method compares the percentage of mice experiencing convulsions after insulin injection between samples and a standard. The rat diaphragm and epididymal fat pad methods measure glucose uptake in tissue samples incubated with insulin to determine insulin-like activity.
This document discusses the immunoassay of insulin. It begins with introducing immunoassays and their principle of competitive binding between labeled and unlabeled analytes for antibody binding sites. It describes the key reagents of antigens, antibodies, signal-generating labels, and separation matrices. The document then focuses on insulin as the analyte and outlines the specific procedure for its immunoassay, including using guinea pigs to produce antibodies, running standards and samples in assays, and evaluating the results against a standard curve to determine insulin concentrations.
It was one of my presentation for my master's in pharmacy. It assisted me in better understanding the many pharmacy research fields as well as what to do before, during, and following a research project. I am hoping that it will also provide the readers a better understanding of the fascinating world of research.
COVID-19:
Introduction
immunosenescence, ARDS,
Hyperinflammation and mortality
Cytokine storm , Inflammatory storm,
Treatment of COVID-19,
Acalabrunitib, Tocilizumab, Anakinra and Itolizumab,
Roleof itolizumab in suppressing the cytokine storm.
Approval status of Itolizumab.
Treatment with the anti-CD6 MAb Itolizumab.
Current status of itolizumab in the treatment of COVID-19,
Common side effects of itolizumab.
Expert opinion
Biopharmaceutics & Pharmacokinetics (Ultimate final note)MdNazmulIslamTanmoy
Intravenous Infusion (IV): Define intravenous infusion. Write down advantages and disadvantages of intravenous infusion,
Write down the pharmacokinetics of IV infusion, Calculate the plasma drug concentration at steady-state after IV infusion, Determine the half life (t1/2) by IV infusion method, Show that in case of IV infusion the time to reach 99% steady-state is 6.65 t1/2.
Multiple-Dosage Regimens: Write a short note on Multiple-Dosage Regimens. What are the basic considerations for multiple dosage regimen?, What are the purposes of multiple-dosage regimens (MDR)? Write down the importance of MDR, Write short note on repetitive intravenous injections, Prove that C∞av is not arithmetic average of C∞max and C∞min, Give brief description on superposition principle and Plateau principle?.
Individualization: Write down about individualization of drug dosing regimen? What are the advantages of individualization? How will you optimizing dosage regimen?, What are the sources of variability in drug response? What are the causes of Inter subject Pharmacokinetics Variability? Write down the steps involved in individualization of dosage regimen?, Write short note on – dosing of drug in obese patient and also discuss about dosing of drug in neonates, infants and children?, Write down about dosing of drug in elderly and hepatic disease? Give some examples of drugs who's conc. Changes due to hepatic impairment?, Explain some clinical experience with individualization and optimization based on plasma drug levels?
NON-linear pharmacokinetics: Derive the Michaelis-Menten Equation or Non-Liner pharmacokinetic and Linear pharmacokinetic model, Define non-linear pharmacokinetics. Why it is called dose dependent pharmacokinetics?, Why Michaelis-Menten equation is termed as mixed order kinetics?, A given drug is metabolized by capacity-limited pharmacokinetics. Assume KM is 50훍g/mL, Vmax is 20훍g/mL per hour and apparent VD is 20 L/kg, Differentiate between linear & non-linear Pharmacokinetics.
Non-compartment model: Briefly describe compartment model?, Briefly describe non-compartment model?, What is MRT? Write down the importance of MRT?, What is MAT? Write down the importance of MAT?, Compare between compartment model and non-compartment models.
Carcinogenesis
Theories of carcinogenesis
Hallmarks of cancer
Important Oncogenes
RB & p53 genes
Metastasis
Aetiology and Pathogenesis of cancer
Tests for carcinogenicity
How to repair damaged DNA?
Basic DNA repair mechanism
Repair of double stranded break
Hydrogels,
introduction,
historical background,
properties,
classification,
difference between chemical and physical hydrogels,
common uses,
pharmaceutical applications,
preparation methods,
list of monomers used,
analytical machines,
advantages,
disadvantages,
conclusion
Spermatogenesis steps, hormonal regulation and abnormalitiesMdNazmulIslamTanmoy
Spermatogenesis is the process by which sperm cells are produced in males. It occurs in three stages: spermatocytogenesis where spermatogonia proliferate into primary spermatocytes, meiosis where primary spermatocytes undergo two divisions to form spermatids, and spermiogenesis where spermatids undergo changes to form spermatozoa. Hormones like testosterone, LH, FSH, growth hormone, and estrogen regulate spermatogenesis by stimulating Leydig and Sertoli cells. Abnormalities can result in conditions like azoospermia, oligozoospermia, and teratozoospermia.
Enzyme catalysed reactions, enzyme kinetics and it’s mechanism of action.MdNazmulIslamTanmoy
Enzymes are protein catalysts that regulate chemical reactions in living organisms. They accelerate reactions by lowering the activation energy of transition states through interactions with substrates. Enzymes are classified based on the type of reaction they catalyze, such as oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Enzyme kinetics follow the Michaelis-Menten model where the enzyme-substrate complex breaks down into products. The catalytic activity of enzymes is explained by thermodynamic changes in transition states and specific interactions between the enzyme and substrate at its active site.
Spli2 is launching a new portable water filter called Spli2 to provide consumers with affordable and environmentally friendly access to clean drinking water. The filter removes bacteria and other contaminants at rates exceeding EPA standards. It is a low-cost alternative to bottled water that also reduces plastic waste. Spli2 aims to market the filter through displays in grocery and convenience stores near bottled water. It will target health-conscious urban consumers and emphasize the product's affordability, portability, quality and environmental benefits over bottled water.
E. Salt form of the drug
F. Lipophilicity of the drug
pH partition theory
Assumption of PH partition theory
Diagram showing the transfer of drug across the membrane
Limitations of pH-partition hypothesis
(Q.U): Mathematical problem
Formulation factors affecting drug availability
First pass effect
Gastric emptying time
Gastrointestinal motility
Short note on Gastric emptying and motility
Physicochemical factors affecting drug absorption
A. Drug solubility and dissolution rate
B. Particle size and surface area of drugs
C. Polymorphism and amorphism
D. Hydrate or solvates
Biopharmaceutical classification system of drug
This document introduces physiological factors influencing drug availability, including the circulatory system and mechanisms of drug absorption across membranes. The circulatory system transports nutrients, oxygen, and wastes through the heart, blood, and vessels. There are three types of circulation: systemic circulation carries oxygenated blood from the heart to cells and back, pulmonary circulation moves deoxygenated blood between the heart and lungs, and portal circulation transports blood from the intestines to the liver. Drug absorption is influenced by membrane physiology, with mechanisms including carrier-mediated transport like active transport against gradients and facilitated diffusion, as well as non-carrier mediated simple diffusion down concentration gradients.
This document introduces concepts related to biopharmaceutics including Fick's first law of diffusion, gastrointestinal physiology, and the relationship between drug products and their pharmacological action. It defines key terms such as absorption, distribution, metabolism, and excretion. Fick's first law states that the rate of diffusion across a membrane is proportional to the difference in drug concentration on each side. The document also describes the anatomy and protective mucous layer of the gastrointestinal tract, and explains that orally administered drugs must dissolve before being absorbed and distributed throughout the body, where they may act, be stored, metabolized, or excreted.
ADRs
Classifications of ADRs
Thompson and DoTS system classification
Factors: age, gender, Co-morbidities, ethnicity, Pharmacogenetics,G6PD deficiency, porphyrias
Immunological reactions
Classifications
Epidemiology and pharmacovigilance of ADRs
Yellow card scheme,
Thalidomide tragedy
Factors that may raise or suppress suspicion of a drug
The liver is the largest gland in the body and performs many critical metabolic functions like carbohydrate and protein metabolism. It also plays an important role in hormone regulation, bile production, and blood clotting factor synthesis. Chronic liver disease can lead to liver fibrosis and cirrhosis over many years. Cirrhosis is characterized by liver scarring and nodule formation, resulting in loss of liver function. Common causes include alcohol abuse, viral hepatitis, and non-alcoholic fatty liver disease. Complications arise due to portal hypertension and liver failure. Diagnosis involves liver biopsy or lab tests showing abnormalities in liver enzymes and clotting factors.
HPLC
Chromatography
Mobile Phase & Stationary Phase
CLASSIFICATION OF CHROMATOGRAPHY
Characteristics of HPLC
Purpose
Superiority of HPLC
TYPES OF HPLC TECHNIQYES
Principle
PHASING SYSTEM & (normal vs reversed phase)
INSTRUMENTATION
Flow diagram of HPLC instrument
Advantages of HPLC
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
Gender and Mental Health - Counselling and Family Therapy Applications and In...PsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
This presentation was provided by Rebecca Benner, Ph.D., of the American Society of Anesthesiologists, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
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Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
1. 1
Gono Bishwabidyalay
Nolam, Saver, Dhaka
Assignment on Parenteral Products
Submitted To:
Md. Khalequezzaman
Senior Lecturer
Department of pharmacy, GB
Submitted By:
Md. Nazmul Islam Tanmoy
Class roll: 74
Exam roll: 2064
Batch: 32
Semester: 6th
Department of pharmacy, GB.
Course title: Industrial Pharmacy &
Pharmaceutical Technology-II (pharn-3601)
2. 2
INTRODUCTION:
• Parenteral preparations are sterile, pyrogen-free liquids (solutions,
emulsions, or suspensions) or solid dosage forms containing one or more
active ingredients, packaged in either single-dose or multi-dose containers.
• The term Parenteral derived from two Greek words 'Para' outside &
'Enterone' intestine.
• Thus are intended for administration by injection, infusion, or
implementation into Parenteral drugs are administrated directly into veins,
muscles or under the skin or more specialized tissues such as the spinal cord.
the body.
Definitions
➢ BP: “Parenteral preparations are sterile preparations intended for
administration by injection, infusion or implantation into human or animal
bodies"
➢ WHO: Parenteral preparations are sterile, pyrogen-free liquids (solutions,
emulsions, or suspensions) or solid dosage forms containing one or more
active ingredients, packaged in either single-dose or multidose containers.
They are intended for administration by injection, infusion, or implantation
into the body.
➢ In short Parenteral preparations are defined as solutions, suspensions,
emulsions for injection or infusion, powders for injection or infusion, gels
for injection and implants.
➢ They are sterile preparations intended to be administered directly into the
systemic circulation in humans or animals.
Unique Characteristics of Parenteral products
• Sterile Particulate-free
• Pyrogen free
• Stable for intended use
• pH - not vary significantly
• Osmotic pressure similar to blood
3. 3
Categories of parenteral preparations:
▪ Injections or infusions
▪ Concentrates for injections or infusions
▪ Powders for injection or infusions
▪ Gels for injections
▪ Implants
Routes of Parenteral Administration
• Intradermal (I.D)
• Subcutaneous (S.C)
• Intramuscular (I.M)
• Intravenous (I.V)
• Intra-arterial
• Intracardiac
• Intra-articular (joint)
• Intrasynovial (joint fluid area)
• Intraspinal, Intrathecal (spinal fluid)
Characteristics of parenteral Preparations
• Intravenous (IV) preparations are either:
➢ solutions (in which ingredients are dissolved)
➢ suspensions (in which ingredients are suspended)
• Most parenteral preparations are made of ingredients in a sterile water
medium.
• Some parenteral preparations may be oleaginous (oily).
• Parenteral IV preparations must have chemical properties that will not:
➢ damage vessels or blood cells
➢ alter the chemical properties of the blood serum
• With blood, IVs must be:
➢ iso-osmotic
➢ Isotonic
• Human blood plasma has a pH of 7.4
➢ slightly alkaline
➢ parenteral IV solutions should have a pH that is neutral (near 7)
• Characteristics of parenteral preparations that are important to adjust:
4. 4
➢ Tonicity,
➢ Osmolality,
➢ pH are characteristics of parenteral preparations.
➢ It is important that they be adjusted to be as close as possible to the
values for human blood, to prevent damage to blood cells and organs.
Advantages of Parenteral Administration
➢ Fastest method of drug delivery
➢ Viable alternative
➢ Use for Uncooperative patients
➢ Nauseous patients
➢ Unconscious patients
➢ Less patient control
➢ For the patient who can have nothing by mouth
➢ Prolonged action
➢ Correcting serious fluids and electrolyte imbalance
➢ TPN
Disadvantages of Parenteral Administration
• Trained personnel
• Pain
• Difficult to reverse an administered drug's effects
• Manufacturing and Packaging requirements
• Cost
• Needle sticks Injury
Insulin Injection
Introduction:
• Insulin is a peptide hormone, produced by beta cells of the pancreas and is
central to regulating carbohydrate and fat metabolism in the body.
• Insulin is the mainstay of treatment for patients with type-1 diabetes and also
important in type-2 diabetes when blood glucose levels cannot be controlled
by diet and medicines.
5. 5
• In diabetes treatment, Insulin is mostly administered by injections, Insulin
pen and Insulin pump
• Mostly referred to as "HUMULIN".
• Its potency, calculated on the dried basis, is not less than 26.5 USP Insulin
Units in each mg;
• Insulin labeled as purified contains not less than 27.0 USP Insulin Units in
each mg, calculated on the dried basis.
• The proinsulin content, determined by a validated method, is not more than
10 ppm.
• NOTE-One USP Insulin Unit is equivalent to 0.0342 mg of pure Insulin
derived from beef or 0.0345 mg of pure Insulin derived from pork.
❖ Different formulations of Insulin:
❖Injectable Insulin Preparation
• Injectable insulin preparations are sterile preparation of insulin (human
insulin, bovine or insulin porcine).
• They contain NLT 90% and NMT the equivalent of 110% of the amount of
insulin stated on the label.
• They are either solutions or suspensions or they are prepared by combining
solutions and suspensions.
• Recombinant human insulin: a form of insulin (trade name Humulin) made
from recombinant DNA which is human insulin.
6. 6
Methods of insulin production:
There two main methods exist for the production of recombinant human insulin
from genetically modified bacterial cultures:
Two chain method (both A & B chain are synthesized by separate E. coli plasmid).
Proinsulin method (intracellular or secreted).
The proinsulin method is currently the most efficient method because, single
isolation & isolation steps involved.
A. Innoculum preparation:
➢ According to design process:
- six 200 ml test tubes need to grow for initial culture of proinsulin producing
bacteria
- 1L of tryptic soy broth
- 5g of kanamycin monosulfate
- 5g of the genetically altered E .coli
- Grow for 24 hrs at 37 ° c
- Then placed with a in bioreactor to promote further growth & proinsulin
production.
B. Media preparation:
• The E. coli must be placed in a mixture containing the essential building
blocks for growth, including carbon, nitrogen, phosphorus.
1. Bioreactor with 23L total volume & 16L working volume.
2. The 1L of E.coli & depleted growth medium is mixed with 9L of growth
media in bioreactor. (For C- glycerol & yeast extract, N- A. sulphate &
thiamine,)
3. Buffer: pota. dihydrogen phosphate & dipota. phosphate.
4. pH: at 7.
5. 0ther nutrients included in the broth are Na. citrate, Mg. sulphate, a
trace element solution, & a vitamin solution.
6. The oxygen tension is also monitored to be kept at a tension level of
30%.
7. 7
C. Fermentation process of insulin production:
1. Fermentation: The first of the process is to grow enough of the
proinsulin producing E. coli bacteria so as to acquire a sufficient amount
of insulin per process.
- In order to do this an original amount of E. coli cells containing the plasmid
for proinsulin production will be grown in test tubes containing tryptic soy
broth & kanamycin mono-sulphate.
- All of the accomplished by placing the original growth mixture into a
bioreactor in which the parameters can be controlled for maximum cell
growth & insulin production.
- Within a bioreactor the temperature, PH, foam, & feed can be controlled
automatically to yield maximum result.
- Equipment: BioNet Reactor.
- Reagents Involved:
➢ 1L inoculation solution
➢ 25mL NH3
➢ 30mL H3PO4
➢ 100mL 87% glycerol feed
➢ 25g (NH4) 2S04
➢ 30G KH2PO4 * H2O
➢ 20G KHPO4 * 2H2O
➢ 5g Na3-citrate
➢ 10g yeast extract
➢ 0.7g thiamine
➢ 10ml trace element solution
➢ 6.5mL vitamin solution
8. 8
➢ 10ml adecanol -109 (antifoam)
➢ 10ml B-indole acrylic acid
➢ Water up to 10L total
- Parameters:
➢ 10L total working volume
➢ 31 hours growth phase
➢ pH 7
➢ 37 C
2. Centrifugation: Here used for four times throughout the process.
- Equipment: Avanti J-HC
i) Cell isolation: The first steps in insulin production is the isolation of
the bacterium containing proinsulin inclusion bodies, this process also
called cell harvesting. cell harvesting could be used including
filtration & centrifugation.
Parameter: 7500g for 10 min.
ii) Indusion body separation: Proinsulin from rest of cell debris by
centrifugation or reverse osmosis.
Parameter: 15000g for 30 min.
iii) Additional Separation: for removal of reagents.
Parameter: 17700g for 33 min.
iv) Volume reduction: Prior to downstream purification.
Parameter: 17700g for 33min.
3. Cell disruption- Homogenization: By high pressure or alkali treatment.
- Equipment: Nano DeBEE Electric Blade-type Homogenizer.
- Parameter: homogenizer supplies pressure of 45,000 PSI & Flow rate:
150ml / min (3L E.coli cell mixture for 20 min)
4. Centrifugation: Same as previous.
9. 9
5. Solubilize inclusion bodies: Solubilization of inclusion bodies is carried
out by addition of a denaturing agent such as urea or guaminidinium-
HCL (GdmHCL) .these agent denature the fusion proteins composing the
inclusion bodies.
Parameter: Stirring for 6hr at 37 C 8M Urea added.
6. Sulfitolysis: Sulfitolysis involves addition of -SO, groups to the reduced
sulfur residues on cysteines of proinsulin polypeptides, preventing the
formation of potentially incorrect disulfide bonds during the
solubilization and early purification steps prior to correct refolding of the
proteins.
. Incorrect disulfide bond formation during the solubilization and
renaturation processes of proinsulin production accounts for a significant
decrease in percentage yield.
Parameter:
- Performed during 6hr solubilizing step
- 0.8M Na2SO4
- 0.3M Na2SO4 * 2H2O
7. Centrifugation: Same as previous.
8. Dialysis: Effectively removes denaturants (urea, beta-mercaptoethanol or
DDT) & dissolved contaminants (buffer-tris-HCL, & solubilizing
agents).
Equipment: Spectra / par 1 membrane, MWCO 6-8000.
Parameters: 4 repetitions
Washing buffer: 10mM Tris-HCI (pH 8).
9. Renaturation: To maximize correct bond formation.
Parameters: Stirring for 20hr at 4 C
1M glycine NaOH (pH 10.5+)
18: 1 molal ratio of B-mercaptoethanol to fusion protein
10.Centrifugation: same as previous.
11.Purification:
i). Affinity chromatography: isolation of proinsulin peptide from fusion
protein, further purification is required to produce an insulin product pure
enough for patient use.
Equipment: IgG-Sepharose column
10. 10
SDS-PAGE
Superdex 75 PC3.2 / 10
Parameters: 0.3M acetic acid added until pH of 8 is reached
Ammonium acetate
200mM sodium phosphate
Quality control of Insulin
• After every one of the many steps of purification, scientists check and
double-check the insulin's purity.
• Even the packaging process is super-tightly regulated, as each vial of insulin
is photographed from many angles.
• There are many quality control tests performed at manufacturing site
according to its type of formulation.
Quality Control parameter for Injectable Insulin preparation
1. pH It should be 6.9 to 7.8 otherwise as per specific monograph.
2. Insulin in the supernatant
- should be NMT 2.5% of the total insulin content, and insulin content of
supernatant liquid (s) is determined by chromatographic method.
- % Insulin = 100S / T (T: - total insulin content determined by assay)
3. Impurities with molecular masses greater than that of insulin
- It is examined by size-exclusion chromatography.
4 Related proteins It is examined by liquid chromatography.
5 Total Zinc It is determined by atomic absorption spectroscopy.
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- Prepare test and reference solutions and measure absorbance at 213.9 nm
using a zinc hollow cathode lamp or air-acetylene flame as source of
radiation.
6. Bacterial endotoxins should be less than 80 IU per 100 IU of insulin.
7. Assay
examine by liquid chromatography. Mostly, it is carried out by High
Performance Liquid Chromatography (HPLC).
- Test solution: It is prepared by adding 4ul of 6 M HCL per ml of preparation
and with an additional dilution by 0.01 M HCL.
- Reference solution: It is prepared by dissolving insulin in 0.01 M HCL to get
conc. 4 mg / ml and then addition of 1ml of bovine insulin and 1ml of
porcine insulin.
8. Sterility
- Sterility or freedom from presence of viable microorganisms is a strict,
uncompromising requirement of an injectable dosage form.
- Sterility test is performed by following tests,
1. Pyrogen Testing
• LAL test (Gel clot test and Chromogenic test)
the result is expressed in EU / ml.
• Rabbit pyrogen test
Insulin zinc forms ppts. in sterility test media. Ascorbic acid at 1% in
0.1% peptone (% w/v) dissolves protamine zinc and insulin zinc in no
more than one minute without harming organisms.
2. Particulate Matter Testing
• Visual Inspection Test
(i) Manual Methods
- off-line Inspection (Personnel)
(ii) Automatic Methods
- Auto scan System
- Electronic Particle Counters
9. Stability Test
The stability studies are done at 5 ° C (refrigerator) and at room temperature (20 -
25 ° C) under the following conditions.
• In acidic medium (0.01M HCI, pH 2.0) and at room temperature.
. In acidic medium (0.10M HCI, pH 1.0) and at room temperature.
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• In basic medium (0.10M NaOH, pH 13.0) and at room temperature
• In phosphate buffer medium (0.10M, pH 7.4) and at room temperature.
10. Package Integrity Testing
Package integrity is the measure of a package's ability to keep the product in
and to keep potential contamination out.
• Package Integrity Tests:
- Acoustic Imaging
- Ultrasonic Imaging
- High Voltage Leak Detection
- Noninvasive Moisture and Oxygen Analysis O Residual Gas Ionization Test
- Residual Seal Force
- Microbial Challenge Test
- Visual Inspection
- Vacuum / Pressure Decay
- Weight Change
- Bubble Test
- Gas Tracer Detection
- Helium Mass Spectrometry
- Liquid Tracer Test
Common quality control tests for Insulin preparations.
1. Inertness of preparation
It is checked by Capillary electrophoresis. Basically it is used to predict
protein interaction with the capillary wall or with other protein.
2. Structural analysis of Protein
It is analyzed by hydrolysis, pre and post column derivatization, Aufomated
Edman sequencing.
3. Validation Parameters
▪ Linearity Three samples from each of the concentrations (10-100 ug /
ml) used for construction of standard curve and for checking
Linearity.
▪ Precision
Six samples from the concentration range (10-100 ug / ml) is used for
construction of standard curve and analyzed in one day or six different
days in order to evaluate intra-day or inter-day variations (Precision)
respectively
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▪ Range
It is taken between 10 - 100 µg / ml.
▪ Accuracy
The accuracy experiment is performed on four different
concentrations (each injected three times) covering the linear range.
▪ LOD (Limit of Detection)
▪ LOQ (Limit of Quantitation)
▪ Sensitivity
Packaging and Packaging materials
Glass containers are used as insulin vial because they offer some
important benefits that other materials don't offer. They are formed by
blowing, drawing, pressing, and casting. Some advantages of glass
containers are there that make them fantastic option for pharmaceutical
uses.
- They are easy to sterilize with heat.
- Colored glass has the ability to protect its content from certain wavelengths
which include the ultraviolet rays of the sun.
- They are chemically inert and will not react with their content.
- They are impermeable to water and air and that makes them a great storage
facility for drugs.
- They are transparent so, their content can be seen without opening them.
It is also important to let you know that not all glass containers are good for
pharmaceutical use. The factors considered when selecting glass containers are
sensitivity to calcium and barium ions, thermal expansion properties, hydrolytic
resistance, and limited alkalinity. This is why glass containers are categorized
into different types for pharmaceutical uses.
Types of Glass Containers
Glass containers are classified into Types I, Il, III, and IV.
Type I Glass Containers
This type of glass contains 10% of boric oxide, 80% of silica, and small
quantities of both aluminum oxide and sodium oxide. The boric oxide in it
makes it highly hydrolytically resistant and chemically inert. In addition, its
coefficient of expansion is very low and high its thermal shock property is quite
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high. Due to its characteristics, a Type I glass container is great for packaging
materials for a lot of parenteral and non-parenteral preparations. It can also be
used to store strong alkalis and acids.
Type II Glass Containers
This is similar to Type II containers. In fact, a Type II glass container is
regarded as a modified Type II container. Type Il containers have high
hydrolytic resistance. Type Il glass containers are actually Type III containers
whose inner surface have been treated with sulfur. This treatment helps to
prevent weathering from the containers. Type II glass generally has a lower
melting point than Type I glass so it is much easier to mold. Type II glass
containers are suitable for storing neutral aqueous preparations and acidic
preparations whether they are parenteral or non-parenteral.
Type III Glass Containers
This type of glass containers is made of 10% calcium oxide, 15% sodium oxide,
and 75% silica. They also contain negligible amounts of aluminum oxide,
potassium oxide, and magnesium oxide. While magnesium oxide reduces the
temperature required to mold the glass, aluminum oxide improves its chemical
durability. This type of glass container is used for packaging non-parenteral
preparations and for packaging certain parenteral products.
Type IV Glass Containers
This type of glass containers contains general- purpose soda lime and they have
low hydrolytic resistance. This category of glass containers is the best for
products that are meant to be autoclaved because the rate of erosion reaction of
the glass containers will be increased. Type IV glass containers are used for the
storage of oral dosage forms and topical products.
In summary, glass containers are classified into Types I, II, III, and IV for
pharmaceutical uses but type II is the best suitable material for insulin.
CLOSURES:
Rubber consists of long chain polymers of isoprene units linked together in the
cis-position. Hevea braziliensis is the most important source of rubber. Its latex
contains 30% to 40% of rubber in colloidal suspension. Usually closures for
parenteral products are made from
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1. Natural rubber
2. Synthetic rubber & Characteristics of good pharmaceutical rubber:
A good pharmaceutically used rubber consists of the following criteria:
• Should show good aging property.
• Should have satisfactory hardness and elasticity.
• Should have resistance to sterilization conditions.
• Should not affect by moisture and air.
• Should have low permeability to moisture and air.
• Should have negligible release of undesirable substances.
• Should have negligible extraction of injection ingredients.
CONCLUSION
- Quality control should be a fundamental segment Of parenteral products
manufacturing.
- All of the 5 basic tests which are performed are essential and have its own
importance in parenteral production.
- All of these tests ensure that product meet its quality which has been judged
to satisfactory also.
- Each test is unique and provides detailed assessment of quality control for
parenteral products.