This document provides information on suppositories including their definition, uses, and factors affecting absorption. Suppositories are solid dosage forms intended for insertion into body orifices where they melt and exert local or systemic effects. Rectal suppositories can relieve constipation or hemorrhoid symptoms, while others may provide systemic drug delivery. Drug absorption from suppositories is influenced by factors like the drug's solubility, the suppository base used, and physiological conditions in the rectum. Common suppository bases include cocoa butter and synthetic fats that melt at body temperature for drug release.
Rectal suppositories are solid dosage forms intended for insertion into the rectum. They contain a medicated ingredient incorporated into a base such as cocoa butter or PEG that melts or dissolves at body temperature, allowing the ingredient to be absorbed. Suppositories can be used to produce local effects in the rectum or systemic effects throughout the body. The ideal suppository base is non-irritating, compatible with drugs, and melts at body temperature to release the medication.
This document discusses powder dosage forms, including their definition, advantages, disadvantages, classification, formulation, and characterization. Powders are intimate mixtures of dry, finely divided drugs and/or chemicals that can be used internally or externally. They have advantages like good stability, rapid onset of action, and ease of administration. However, they are not suitable for unstable, bitter, or hygroscopic drugs. The document outlines methods for obtaining powders, mixing them, and packaging different types including bulk powders, snuffs, dental powders, and insufflations. Characterization parameters like particle size and flow properties that influence formulation are also described.
Solid unit dosage forms the drug is enclosed within the water-soluble shell or an envelope either a hard or soft shell. Shell is typically made of gelatin primarily intended for oral delivery and provides a rapid release of contents.
Generally, the shells are formed from gelatin.
This document provides instructions for preparing different types of suspensions. It describes taking solids and triturating them in a mortar and pestle with a vehicle like tragacanth mucilage to form a smooth cream. It also discusses precipitate forming liquids, which are added slowly with rapid stirring. Another method involves mixing diluted solutions to form a precipitate that is distributed throughout the liquid by shaking. The document concludes with packaging, storage and stability considerations for suspensions.
Powders are solid dosage forms consisting of finely divided drugs and chemicals meant for both internal and external use. They are classified as bulk powders, divided powders, granules, and those contained in capsules. Bulk powders are less accurate but more stable than other forms. Divided powders allow accurate dosing. Granules can mask unpleasant tastes and are easier to swallow than powders. Other solid dosage forms discussed include tablets, capsules, lozenges, pills, and pastilles, each having advantages and disadvantages for drug delivery and patient acceptance.
This document discusses classical dosage forms, which include pills, lozenges, mixtures, inhalations, powders, glycerites, throat paints, elixirs, draughts, granules, solutions, pessaries, tinctures, and syrups. It provides details on the composition, preparation, uses, and examples of each type of classical dosage form. Classical dosage forms were commonly used in ancient times but have been replaced by more advanced forms in modern times due to various disadvantages like poor stability or ease of administration.
Compression coated tablet techniques by prashikprashikvaidya
This document discusses compression coated tablet technology for drug delivery. It begins with an introduction that defines compression coated tablets as having an inner core completely surrounded by a coating layer. This technique is used to provide a lag phase followed by controlled drug release. The document then discusses various approaches for drug release like multiphasic, delayed, time controlled and pH controlled release. It also covers factors affecting the coating process and advantages like taste masking and moisture protection. The document concludes with discussing recent technologies like osmotic controlled release and inlay tablets.
Granules are aggregations of fine powder particles that are roughly spherical in shape. They are produced to improve powder flowability, enhance compressibility, reduce toxicity, and prevent caking. There are three main granulation methods: wet granulation, dry granulation, and granulation by crystallization. Wet granulation is most common and involves mixing powder with a liquid to form a paste, then granulating and drying the paste. Granules are sieved after drying to achieve a uniform size distribution suitable for their intended use as a final or intermediate pharmaceutical product. Quality tests such as dissolution and friability are performed to ensure granule properties are suitable.
Rectal suppositories are solid dosage forms intended for insertion into the rectum. They contain a medicated ingredient incorporated into a base such as cocoa butter or PEG that melts or dissolves at body temperature, allowing the ingredient to be absorbed. Suppositories can be used to produce local effects in the rectum or systemic effects throughout the body. The ideal suppository base is non-irritating, compatible with drugs, and melts at body temperature to release the medication.
This document discusses powder dosage forms, including their definition, advantages, disadvantages, classification, formulation, and characterization. Powders are intimate mixtures of dry, finely divided drugs and/or chemicals that can be used internally or externally. They have advantages like good stability, rapid onset of action, and ease of administration. However, they are not suitable for unstable, bitter, or hygroscopic drugs. The document outlines methods for obtaining powders, mixing them, and packaging different types including bulk powders, snuffs, dental powders, and insufflations. Characterization parameters like particle size and flow properties that influence formulation are also described.
Solid unit dosage forms the drug is enclosed within the water-soluble shell or an envelope either a hard or soft shell. Shell is typically made of gelatin primarily intended for oral delivery and provides a rapid release of contents.
Generally, the shells are formed from gelatin.
This document provides instructions for preparing different types of suspensions. It describes taking solids and triturating them in a mortar and pestle with a vehicle like tragacanth mucilage to form a smooth cream. It also discusses precipitate forming liquids, which are added slowly with rapid stirring. Another method involves mixing diluted solutions to form a precipitate that is distributed throughout the liquid by shaking. The document concludes with packaging, storage and stability considerations for suspensions.
Powders are solid dosage forms consisting of finely divided drugs and chemicals meant for both internal and external use. They are classified as bulk powders, divided powders, granules, and those contained in capsules. Bulk powders are less accurate but more stable than other forms. Divided powders allow accurate dosing. Granules can mask unpleasant tastes and are easier to swallow than powders. Other solid dosage forms discussed include tablets, capsules, lozenges, pills, and pastilles, each having advantages and disadvantages for drug delivery and patient acceptance.
This document discusses classical dosage forms, which include pills, lozenges, mixtures, inhalations, powders, glycerites, throat paints, elixirs, draughts, granules, solutions, pessaries, tinctures, and syrups. It provides details on the composition, preparation, uses, and examples of each type of classical dosage form. Classical dosage forms were commonly used in ancient times but have been replaced by more advanced forms in modern times due to various disadvantages like poor stability or ease of administration.
Compression coated tablet techniques by prashikprashikvaidya
This document discusses compression coated tablet technology for drug delivery. It begins with an introduction that defines compression coated tablets as having an inner core completely surrounded by a coating layer. This technique is used to provide a lag phase followed by controlled drug release. The document then discusses various approaches for drug release like multiphasic, delayed, time controlled and pH controlled release. It also covers factors affecting the coating process and advantages like taste masking and moisture protection. The document concludes with discussing recent technologies like osmotic controlled release and inlay tablets.
Granules are aggregations of fine powder particles that are roughly spherical in shape. They are produced to improve powder flowability, enhance compressibility, reduce toxicity, and prevent caking. There are three main granulation methods: wet granulation, dry granulation, and granulation by crystallization. Wet granulation is most common and involves mixing powder with a liquid to form a paste, then granulating and drying the paste. Granules are sieved after drying to achieve a uniform size distribution suitable for their intended use as a final or intermediate pharmaceutical product. Quality tests such as dissolution and friability are performed to ensure granule properties are suitable.
This document summarizes a seminar presentation on powder dosage forms for external use. It defines powders as intimate mixtures of drugs and chemicals that may be for internal or external use. Powders are classified as bulk powders, simple/compound powders, powders in capsules, or compressed powders (tablets). Bulk powders for external use include dusting powders, snuffs, and dental powders. Packaging depends on the intended use, with bulk powders in wide-mouth jars and divided powders in individual folded papers. Advantages include stability and convenient dosing, while disadvantages include instability in some conditions and dosing inaccuracies.
Tablets are the most popular oral dosage form, comprising compressed powders into solid dosage units. Tablets can be formulated for immediate release or modified release of the drug. There are several types of tablets including compressed, layered, sugar-coated, film-coated, chewable, sublingual, buccal, lozenges, dental cones, implants, and vaginal/insert tablets. Tablets offer benefits like accurate dosing, stability, low cost and ease of production compared to other dosage forms.
Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine.
This document discusses filtration and clarification processes. It defines key terms like filtration, filter medium, filter cake, and filtrate. It describes how filtration works by restricting solid particle flow while allowing liquid to pass through. Clarification is used when solids are less than 1% and the filtrate is the desired product. Factors that affect filtration rate include surface area, particle size, pore size, resistance, viscosity, temperature, and pressure difference. Common filter media and aids are also outlined. Finally, various filtration equipment like sintered glass filters, filter candles, filter presses, and rotatory filters are described.
Tablets are a common pharmaceutical dosage form made by compressing powders into a solid dose. They contain active ingredients mixed with excipients like diluents, binders, and lubricants. Tablets can be formulated for accurate dosing, specific sites of delivery, and controlled release over time. The manufacturing process involves weighing ingredients, blending, granulation if needed to ensure uniform mixing, drying the granules, compression into tablets, and packaging. Tablet quality is ensured through content uniformity, disintegration, proper sizing and flow properties during production.
his presentation delves into the formulation, advantages, and applications of semisolid dosage forms, including creams, ointments, and gels. Learn about their unique properties, manufacturing processes, and considerations for drug delivery. Whether you're a student or a pharmaceutical professional, this presentation offers valuable insights into this essential aspect of medication delivery.
Dosage forms come in many types, depending on the method or route of administration. Solid dosage forms, semi-solid dosage forms, liquid dosage forms, and gaseous dosage forms are used for the diagnosis or treatment of the disease by various routes. Solid dosage forms are the most significant dosage forms in pharmaceuticals; it has one or more unit dose of medicament. The solid dosage form is the most commonly used and prescribed by doctors as compared to other dosage forms. It can be administered orally in the form of tablets, capsules, powders, etc. Of these, the tablet is one of the most commonly used oral solid dosage forms.
This document discusses semisolid dosage forms such as ointments, pastes, and gels. It describes the different types of ointment bases including oleaginous, absorption, water removable, and water soluble bases. It also outlines the equipment used to produce ointments such as mixers and mills. Finally, it covers packaging of ointments in jars, tubes, and syringes and the processes for filling them.
This document discusses powders and granules used in pharmaceutical formulations. It defines powders and granules and discusses their advantages. Particle size and shape are described. Hard and soft gelatin capsules are summarized, including their manufacturing and filling methods. Sustained release and enteric coated capsules are briefly outlined. Microencapsulation techniques like coacervation and pan coating are introduced. Spray drying is also mentioned as a microencapsulation method.
This document provides information about semisolid dosage forms including ointments, creams, and gels. It discusses the definition, advantages, disadvantages, ideal properties, ingredients used in preparation, methods of preparation, and evaluation of these topical dosage forms. The key components discussed include bases, preservatives, emulsifiers, gelling agents, and antioxidants. Methods of preparation depend on the formulation and can include incorporation, fusion, or emulsification. Evaluation tests assess properties like penetration, release of active ingredients, irritation effects, and stability.
Wet granulation is a process that uses a granulating liquid like ethanol or water to mix powder particles. It involves mixing powders and a binder solution, sieving the wet mixture, drying the granules, and sieving the dry granules. Common methods are shear granulation, fluid bed granulation, and spheronization which forms spheres or pellets. Wet granulation produces granules that compress well and result in tablets with consistent properties, though it uses more energy than dry granulation and powders must be stable with water.
This document discusses different types of semi-solid pharmaceutical formulations including ointments, creams, pastes, poultices, gels, and jellies. It provides details on the general properties, ingredients, and manufacturing methods for each type. Evaluation methods for various semi-solid formulations are also summarized, such as tests to measure penetration, drug release rate, absorption, and irritancy for ointments, and tests of rheology, sensitivity, and biological activity for creams.
This document discusses four methods for manufacturing suppositories: hand rolling, compression molding, fusion molding, and automatic molding. Hand rolling is the oldest and simplest method, involving mixing the drug powder into a suppository base and manually rolling it into rods that are then cut. Compression molding compresses the drug-base mixture into molds using a machine. Fusion molding involves melting the base, adding the drug, and pouring the mixture into molds. Automatic molding is the modern method using a machine to completely mold suppositories at high volumes.
This document discusses different types of mixing operations used in pharmaceutical manufacturing. It describes mixing of powders, liquids, and semi-solids. For powder mixing, it outlines factors that affect mixing like particle size and shape. Common mixers discussed include double cone blenders and agitated powder mixers. For liquid mixing, mechanisms like bulk transport and turbulent transport are described. Equipment like propeller mixers and turbine mixers are used. Semi-solid mixing involves dispersion in a base using mixers like triple roller mills and planetary mixers.
This document provides information on monophasic liquid dosage forms. It defines monophasic forms as liquid preparations with only one phase, represented by a true solution. Advantages include easier swallowing and faster absorption than solids. Key considerations in formulation include drug solubility, choice of solvents, addition of preservatives, and maintaining stability. Proper manufacturing requires consideration of raw materials, equipment, and filling/packaging procedures. Common monophasic dosage forms include oral liquids like syrups and elixirs, and liquids for external use like mouthwashes and ointments.
The document discusses the mechanisms of granulation. It explains that granulation involves collecting particles together through compression or using a binding agent to form bonds. There are five primary bonding mechanisms: 1) adhesion and cohesion in immobile liquid films, 2) interfacial forces in mobile liquid films, 3) formation of solid bridges after solvent evaporation, 4) attractive forces between solid particles, and 5) mechanical interlocking. The objectives of granulation are to prevent segregation, improve flow and compaction characteristics, and produce uniform mixtures to enable tableting or spheronization.
Transdermal drug delivery systems (TDDS) deliver drugs through the skin and into systemic circulation at a controlled rate. TDDS provide advantages like avoidance of first-pass metabolism and allowing controlled drug levels. The skin is a barrier, so permeation involves partitioning into the stratum corneum then diffusion across layers. Factors like a drug's physicochemical properties, the delivery system composition, and skin conditions influence permeation kinetics. TDDS have components like polymer matrices, drugs, and permeation enhancers. They are evaluated for properties such as adhesive peel adhesion to ensure removal does not damage skin.
Powders are solid dosage forms where drugs are dispensed in a finely divided state, with or without excipients. They have advantages like faster onset of action compared to other forms but also disadvantages like bitter drugs not being suitable. Powders are prepared through processes like size reduction, weighing ingredients, mixing through methods like spatulation or geometric dilution, and packaging. They are classified based on use and include bulk powders, simple/compound powders, and compressed powders.
Ointments, creams, and lotions are topical semi-solid preparations used to apply active ingredients to the skin. Ointments have a high oil and low water content which allows them to occlude the skin and promote absorption of active ingredients. Creams have a higher water content and are more easily absorbed and spreadable. Lotions have the lowest oil and highest water content, making them lightweight and non-greasy. Ointments are best for dry skin conditions while creams and lotions are better for larger areas or weeping lesions due to being less occlusive and greasy.
This document provides information on suppositories, including their uses, advantages, challenges, and formulation considerations. Suppositories can be used to deliver drugs locally or systemically when oral administration is not possible. They melt or dissolve at body temperature for drug release and absorption. The document discusses important properties of suppository bases like cocoa butter and synthetic triglycerides, as well as factors that influence drug release and absorption from suppositories. It also provides details on the anatomy and physiology of the rectum relevant to suppository administration.
This document discusses rectal and vaginal dosage forms, including suppositories. It provides details on the physiology of the rectum and vagina, as well as formulations, manufacturing processes, and advantages and disadvantages of various rectal and vaginal dosage forms. Specifically, it describes the components, production processes, and quality control testing for suppositories manufactured via fusion or compression molding on an industrial scale. It also discusses other rectal and vaginal dosage forms such as creams, ointments, gels, solutions, and capsules.
This document summarizes a seminar presentation on powder dosage forms for external use. It defines powders as intimate mixtures of drugs and chemicals that may be for internal or external use. Powders are classified as bulk powders, simple/compound powders, powders in capsules, or compressed powders (tablets). Bulk powders for external use include dusting powders, snuffs, and dental powders. Packaging depends on the intended use, with bulk powders in wide-mouth jars and divided powders in individual folded papers. Advantages include stability and convenient dosing, while disadvantages include instability in some conditions and dosing inaccuracies.
Tablets are the most popular oral dosage form, comprising compressed powders into solid dosage units. Tablets can be formulated for immediate release or modified release of the drug. There are several types of tablets including compressed, layered, sugar-coated, film-coated, chewable, sublingual, buccal, lozenges, dental cones, implants, and vaginal/insert tablets. Tablets offer benefits like accurate dosing, stability, low cost and ease of production compared to other dosage forms.
Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine.
This document discusses filtration and clarification processes. It defines key terms like filtration, filter medium, filter cake, and filtrate. It describes how filtration works by restricting solid particle flow while allowing liquid to pass through. Clarification is used when solids are less than 1% and the filtrate is the desired product. Factors that affect filtration rate include surface area, particle size, pore size, resistance, viscosity, temperature, and pressure difference. Common filter media and aids are also outlined. Finally, various filtration equipment like sintered glass filters, filter candles, filter presses, and rotatory filters are described.
Tablets are a common pharmaceutical dosage form made by compressing powders into a solid dose. They contain active ingredients mixed with excipients like diluents, binders, and lubricants. Tablets can be formulated for accurate dosing, specific sites of delivery, and controlled release over time. The manufacturing process involves weighing ingredients, blending, granulation if needed to ensure uniform mixing, drying the granules, compression into tablets, and packaging. Tablet quality is ensured through content uniformity, disintegration, proper sizing and flow properties during production.
his presentation delves into the formulation, advantages, and applications of semisolid dosage forms, including creams, ointments, and gels. Learn about their unique properties, manufacturing processes, and considerations for drug delivery. Whether you're a student or a pharmaceutical professional, this presentation offers valuable insights into this essential aspect of medication delivery.
Dosage forms come in many types, depending on the method or route of administration. Solid dosage forms, semi-solid dosage forms, liquid dosage forms, and gaseous dosage forms are used for the diagnosis or treatment of the disease by various routes. Solid dosage forms are the most significant dosage forms in pharmaceuticals; it has one or more unit dose of medicament. The solid dosage form is the most commonly used and prescribed by doctors as compared to other dosage forms. It can be administered orally in the form of tablets, capsules, powders, etc. Of these, the tablet is one of the most commonly used oral solid dosage forms.
This document discusses semisolid dosage forms such as ointments, pastes, and gels. It describes the different types of ointment bases including oleaginous, absorption, water removable, and water soluble bases. It also outlines the equipment used to produce ointments such as mixers and mills. Finally, it covers packaging of ointments in jars, tubes, and syringes and the processes for filling them.
This document discusses powders and granules used in pharmaceutical formulations. It defines powders and granules and discusses their advantages. Particle size and shape are described. Hard and soft gelatin capsules are summarized, including their manufacturing and filling methods. Sustained release and enteric coated capsules are briefly outlined. Microencapsulation techniques like coacervation and pan coating are introduced. Spray drying is also mentioned as a microencapsulation method.
This document provides information about semisolid dosage forms including ointments, creams, and gels. It discusses the definition, advantages, disadvantages, ideal properties, ingredients used in preparation, methods of preparation, and evaluation of these topical dosage forms. The key components discussed include bases, preservatives, emulsifiers, gelling agents, and antioxidants. Methods of preparation depend on the formulation and can include incorporation, fusion, or emulsification. Evaluation tests assess properties like penetration, release of active ingredients, irritation effects, and stability.
Wet granulation is a process that uses a granulating liquid like ethanol or water to mix powder particles. It involves mixing powders and a binder solution, sieving the wet mixture, drying the granules, and sieving the dry granules. Common methods are shear granulation, fluid bed granulation, and spheronization which forms spheres or pellets. Wet granulation produces granules that compress well and result in tablets with consistent properties, though it uses more energy than dry granulation and powders must be stable with water.
This document discusses different types of semi-solid pharmaceutical formulations including ointments, creams, pastes, poultices, gels, and jellies. It provides details on the general properties, ingredients, and manufacturing methods for each type. Evaluation methods for various semi-solid formulations are also summarized, such as tests to measure penetration, drug release rate, absorption, and irritancy for ointments, and tests of rheology, sensitivity, and biological activity for creams.
This document discusses four methods for manufacturing suppositories: hand rolling, compression molding, fusion molding, and automatic molding. Hand rolling is the oldest and simplest method, involving mixing the drug powder into a suppository base and manually rolling it into rods that are then cut. Compression molding compresses the drug-base mixture into molds using a machine. Fusion molding involves melting the base, adding the drug, and pouring the mixture into molds. Automatic molding is the modern method using a machine to completely mold suppositories at high volumes.
This document discusses different types of mixing operations used in pharmaceutical manufacturing. It describes mixing of powders, liquids, and semi-solids. For powder mixing, it outlines factors that affect mixing like particle size and shape. Common mixers discussed include double cone blenders and agitated powder mixers. For liquid mixing, mechanisms like bulk transport and turbulent transport are described. Equipment like propeller mixers and turbine mixers are used. Semi-solid mixing involves dispersion in a base using mixers like triple roller mills and planetary mixers.
This document provides information on monophasic liquid dosage forms. It defines monophasic forms as liquid preparations with only one phase, represented by a true solution. Advantages include easier swallowing and faster absorption than solids. Key considerations in formulation include drug solubility, choice of solvents, addition of preservatives, and maintaining stability. Proper manufacturing requires consideration of raw materials, equipment, and filling/packaging procedures. Common monophasic dosage forms include oral liquids like syrups and elixirs, and liquids for external use like mouthwashes and ointments.
The document discusses the mechanisms of granulation. It explains that granulation involves collecting particles together through compression or using a binding agent to form bonds. There are five primary bonding mechanisms: 1) adhesion and cohesion in immobile liquid films, 2) interfacial forces in mobile liquid films, 3) formation of solid bridges after solvent evaporation, 4) attractive forces between solid particles, and 5) mechanical interlocking. The objectives of granulation are to prevent segregation, improve flow and compaction characteristics, and produce uniform mixtures to enable tableting or spheronization.
Transdermal drug delivery systems (TDDS) deliver drugs through the skin and into systemic circulation at a controlled rate. TDDS provide advantages like avoidance of first-pass metabolism and allowing controlled drug levels. The skin is a barrier, so permeation involves partitioning into the stratum corneum then diffusion across layers. Factors like a drug's physicochemical properties, the delivery system composition, and skin conditions influence permeation kinetics. TDDS have components like polymer matrices, drugs, and permeation enhancers. They are evaluated for properties such as adhesive peel adhesion to ensure removal does not damage skin.
Powders are solid dosage forms where drugs are dispensed in a finely divided state, with or without excipients. They have advantages like faster onset of action compared to other forms but also disadvantages like bitter drugs not being suitable. Powders are prepared through processes like size reduction, weighing ingredients, mixing through methods like spatulation or geometric dilution, and packaging. They are classified based on use and include bulk powders, simple/compound powders, and compressed powders.
Ointments, creams, and lotions are topical semi-solid preparations used to apply active ingredients to the skin. Ointments have a high oil and low water content which allows them to occlude the skin and promote absorption of active ingredients. Creams have a higher water content and are more easily absorbed and spreadable. Lotions have the lowest oil and highest water content, making them lightweight and non-greasy. Ointments are best for dry skin conditions while creams and lotions are better for larger areas or weeping lesions due to being less occlusive and greasy.
This document provides information on suppositories, including their uses, advantages, challenges, and formulation considerations. Suppositories can be used to deliver drugs locally or systemically when oral administration is not possible. They melt or dissolve at body temperature for drug release and absorption. The document discusses important properties of suppository bases like cocoa butter and synthetic triglycerides, as well as factors that influence drug release and absorption from suppositories. It also provides details on the anatomy and physiology of the rectum relevant to suppository administration.
This document discusses rectal and vaginal dosage forms, including suppositories. It provides details on the physiology of the rectum and vagina, as well as formulations, manufacturing processes, and advantages and disadvantages of various rectal and vaginal dosage forms. Specifically, it describes the components, production processes, and quality control testing for suppositories manufactured via fusion or compression molding on an industrial scale. It also discusses other rectal and vaginal dosage forms such as creams, ointments, gels, solutions, and capsules.
Suppositories are solid or semi-solid dosage forms intended for insertion into body cavities like the rectum, vagina, or urethra, where they melt and release medication. Cocoa butter is commonly used as the base for suppositories due to its desirable melting point of 30-35°C, but it has disadvantages like polymorphism and adherence to molds. Other bases include synthetic fats and water-soluble bases like glycerogelatin and macrogols. Drugs suitable for suppositories avoid first-pass metabolism and gastrointestinal irritation. The document discusses suppository formulation, advantages, disadvantages, and administration considerations.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
This document discusses suppositories and pessaries. It defines suppositories as solid dosage forms intended for use in the rectum, vagina, or urethra that melt or soften at body temperature. Pessaries are similar but are compressed tablets that disintegrate in body fluids. The document discusses the BP definitions of suppositories and pessaries. It describes common ingredients in pessaries and the advantages and disadvantages of suppositories. Finally, it covers topics like the characteristics, shapes, uses, and factors affecting drug absorption of suppositories.
This document provides information about suppositories and pessaries. It begins with an introduction to suppositories and their uses. It then discusses the anatomy and physiology of the rectum as the site of administration for many suppositories. Several methods of suppository preparation are described, including hand molding and compression molding. Ideal properties of suppository bases are outlined. The document covers types of bases such as oleaginous, hydrophilic, and water dispersible bases. It also discusses formulation components like antioxidants, emulsifying agents, and preservatives.
Suppositories are solid or semi-solid dosage forms intended for insertion into body cavities like the rectum or vagina. They melt or dissolve in the cavity fluid and exert local or systemic effects. Suppository bases include fatty bases like cocoa butter and hydrogenated oils, water-soluble bases like glycerogelatin and polyethylene glycol, and combinations. Factors affecting drug absorption from suppositories include physiological factors, drug properties, and base properties. Suppositories are used to deliver drugs locally or systemically and have advantages over oral drugs in certain situations.
This document discusses suppositories, including:
- Suppositories are solid dosage forms meant to be inserted into body cavities like the rectum, vagina, urethra, nose, and ear to release drugs locally or systemically.
- They are classified based on the cavity they are meant for, like rectal, vaginal, urethral, nasal, and ear suppositories.
- Ideal suppository bases melt at body temperature, are non-toxic, chemically inert, and compatible with drugs. Common bases include fatty bases like cocoa butter and emulsifying bases like Witepsol.
- Suppositories have advantages like easy administration and avoidance of first-pass metabolism, but also disadvantages
This document discusses suppositories and pessaries. It defines them as solid dosage forms intended for insertion into body cavities like the rectum and vagina. Suppositories are designed to melt or dissolve at body temperature to release their active ingredients. The document discusses the advantages and disadvantages of various suppository bases, including fatty bases like cocoa butter and synthetic fats, as well as water soluble bases like glycero-gelatin and macrogols. It also covers topics like rectal physiology, blood circulation, shapes, sizes, and formulation challenges of suppositories.
This document provides information on suppositories including their history, definition, types, anatomy and physiology of the rectum, absorption from the rectum, factors influencing drug absorption, formulation, and manufacturing. Key points:
- Suppositories were first used in the 18th century by a French pharmacist for rectal drug administration.
- They are solid or semi-solid dosage forms meant to melt or soften at body temperature for local or systemic drug delivery via body cavities like the rectum.
- The rectum is well-suited for drug absorption due to its blood supply and pH. Suppositories can deliver drugs systemically by bypassing first-pass metabolism.
This document provides information on suppositories and pessaries, including how they are used to administer drugs locally or systemically through the rectum or vagina. It discusses desirable criteria for suppository bases and lists some common bases, including fatty bases like Theobroma oil and synthetic fats, and water-soluble bases like glycerol-gelatin and macrogols. The preparation process for suppositories is also outlined, involving melting the base, adding an insoluble drug, stirring, and molding the mixture into suppositories.
Chapter on Search Results Web results Gastro retentive drug delivery system ...Dr. RAJESH L. DUMPALA
The document summarizes a seminar on gastroretentive drug delivery systems (GRDDS). It discusses the merits of GRDDS, including delivering drugs to the small intestine and improving bioavailability. Various gastroretentive technologies are described, including floating, expanding, bioadhesive, and high density systems. Factors affecting GRDDS performance and methods for evaluating different GRDDS are also outlined.
A suppository is a drug delivery system that is inserted into the rectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), where it dissolves or melts and is absorbed into the blood stream. They are used to deliver both systemically and locally acting medications.
This document provides an overview of suppositories including:
- Definition: Suppositories are solid or semi-solid dosage forms meant to melt or dissolve in body cavities to deliver medication locally or systemically.
- Types include rectal, vaginal, nasal, urethral, and ear suppositories.
- Advantages include ease of administration to certain patients and targeted delivery to specific body cavities. Disadvantages include potential embarrassment and need for special storage conditions.
- Common bases include fatty bases like cocoa butter and hydrophilic bases like gelatin that melt at body temperature to release the drug.
The document discusses suspensions, including definitions, classifications, properties, advantages, disadvantages, formulation methods, components, and general formulation procedures. Some key points:
- A suspension is a heterogeneous system with insoluble particles dispersed uniformly throughout a liquid medium. Suspending agents help maintain uniform dispersion.
- Suspensions can be classified based on physical state, proportion of solids, behavior of dispersed phase, particle size, and general type (oral, topical, parenteral).
- Important properties include easy redispersion, no sediment compaction, optimal viscosity, and stability.
- Common formulation methods are precipitation, dispersion, controlled flocculation, and use of structured vehicles. Key components are suspending
The document discusses suspensions, including definitions, classifications, properties, advantages, disadvantages, formulation methods, components, and equipment used. A suspension is a heterogeneous system with small insoluble particles dispersed uniformly throughout a liquid medium. Suspensions can be classified based on physical state, proportion of solids, particle behavior, size, and application (oral, topical, parenteral). Key aspects in formulation include reducing particle size, selecting suspending agents, wetting agents, and structured vehicles. Common equipment used are mortar and pestle, mechanical stirrers, colloid mills, homogenizers, and ultrasonic devices.
Monoclonal antibodies are produced from single clones of B cells and recognize a specific antigen. They have advantages over polyclonal antibodies like homogeneity, specificity, and unlimited production. Monoclonal antibodies are created through cell fusion between B cells and myeloma cells to form immortal hybridoma cells that produce the same antibody. They have various medical uses including cancer therapy, diagnostics, and treatment of autoimmune disorders.
Implantable drug delivery systems provide sustained release of drugs over long periods of time through placement of drug-loaded implants under the skin. There are several types of implant systems including polymeric matrix systems where the drug is dispersed in a polymer, reservoir systems where the drug core is surrounded by a permeable membrane, and biodegradable systems where the implant breaks down over time. Implantable systems can last from weeks to years, improving patient compliance over oral medications by eliminating the need for repeated dosing. Several implantable drug delivery systems have been approved by the FDA to treat conditions like cancer, eye diseases, and bone infections.
Niosomes are non-ionic surfactant vesicles that can encapsulate drugs for delivery. They are similar to liposomes but offer advantages like being more stable and less expensive to produce. Niosomes are microscopic lamellar structures formed when non-ionic surfactants are hydrated in aqueous solution, potentially forming unilamellar or multilamellar vesicles. They can effectively deliver both hydrophilic and hydrophobic drugs and increase bioavailability.
This document discusses inflammation and its mediators. It defines inflammation as the local response to injury and describes the four classic signs as redness, swelling, heat, and pain. There are two main stages of inflammation - acute and chronic. Acute inflammation involves fluid accumulation, platelet activation, and neutrophil infiltration at the site of injury. Chronic inflammation is longer-lasting and involves infiltration by mononuclear cells like lymphocytes and macrophages. Mediators of inflammation include plasma proteins, vasoactive amines, cytokines, and lipid mediators that are involved in regulating the inflammatory response.
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The primary goal may not be absolute optimization but rather an effective compromise that produces the best formulation given certain restrictions. Optimization involves systematically varying factors like concentration, temperature, and polymer grade to determine their effects on responses such as dissolution time, hardness, and reproducibility. Statistical experimental designs are commonly used for optimization and include factorial, response surface, and block designs. These designs help establish relationships between independent variables and dependent responses to find the ideal formulation parameters.
The document provides information on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It describes ICH as a joint initiative involving regulators and industry from the EU, Japan, and US to discuss testing procedures for ensuring safety, quality and efficacy of medicines. The document outlines the objectives, goals, members and structure of ICH. It also provides details on various ICH guidelines related to stability testing, analytical validation, impurities, pharmacopoeias, quality of biotechnological products, specifications for drug substances and products, good manufacturing practices and more.
This document discusses tablets as a type of solid oral dosage form consisting of active ingredients and excipients. It describes the advantages and disadvantages of tablets, as well as the various types including compressed, film coated, enteric coated and sustained release tablets. The document outlines the tablet manufacturing process including granulation, compression, and coating. It discusses important formulation components like diluents, binders, disintegrants, lubricants and various evaluation tests for tablets.
UV/visible spectroscopy involves using electromagnetic radiation in the UV and visible light range to analyze samples. Absorption of this radiation causes electronic transitions between molecular energy levels. The wavelength and intensity of absorption peaks provide information about functional groups in molecules. Factors like conjugation and substituents can cause bathochromic, hypsochromic, hyperchromic, or hypochromic shifts in absorption maxima and intensity. UV/visible spectroscopy has applications in qualitative and quantitative analysis, detection of impurities, and determination of molecular properties.
This document summarizes the history and development of vaccines. It discusses how Edward Jenner developed the smallpox vaccine in 1796 and how vaccines for other diseases like cholera, anthrax, and plague were developed between 1890-1950. Modern vaccines use attenuated or inactivated forms of pathogens. New delivery systems are being researched like DNA vaccines, viral vectors, and plant-based vaccines. Liposomes and virosomes can be used to deliver subunit vaccines and improve immune responses. Oral vaccines are being developed but face challenges with degradation in the gastrointestinal tract.
This document discusses manufacturing considerations for ophthalmic dosage forms. It begins by defining ophthalmic preparations and listing their key requirements like sterility, tonicity, and avoidance of particulates. It then covers the manufacturing environment, personnel requirements, equipment needs, raw materials, and process analytical technology (PAT). Specific manufacturing operations for ophthalmic preparations in glass and plastic containers are outlined, including areas, equipment, and processing steps for water management, container preparation, solution preparation, filling/capping, sterilization, inspection, and packaging. Common ophthalmic dosage forms and their advantages and disadvantages are also briefly mentioned.
This document discusses the effects of sun exposure and properties of sunscreens. Moderate sun exposure provides benefits like vitamin D synthesis, but excessive exposure can cause sunburn, skin damage, and skin cancer. Effective sunscreens contain organic or inorganic agents that absorb UV rays, along with emollients and waterproofing agents. They are formulated as creams, gels, or other products. Sunscreens are rated by their sun protection factor (SPF), with higher SPF providing more protection.
Infrared absorption spectroscopy analyzes infrared light interacting with molecules. When IR radiation hits a molecule, the molecule's bonds absorb the energy and vibrate. There are two main types of vibrations - stretching and bending. Factors like atomic mass and bond strength determine vibrational frequency. Hydrogen bonding occurs between proton donor and acceptor groups and affects frequencies. IR instruments contain sources, sample cells, monochromators, detectors, and recorders. Applications include identifying substances from their unique spectra in the fingerprint region.
The document discusses the Abbreviated New Drug Application (ANDA) process overseen by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). It describes the requirements for an ANDA, including establishing bioequivalence to the reference listed drug through bioequivalence studies, and certifying patent status. Upon receiving an ANDA, the CDER determines if the application is complete and acceptable for review. If approved, generic drugs must demonstrate equivalence to the reference drug in dosage form, strength, quality and performance.
The document discusses the Common Technical Document (CTD) format, which is a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It originated from international harmonization efforts to streamline the drug approval process. The CTD format organizes information into five modules covering administrative information, summaries, quality/manufacturing, nonclinical data, and clinical data. It aims to reduce duplication and facilitate consistent reviews across regions. Submissions using the CTD format are now mandatory in major markets like the US, EU and Japan.
This document provides an overview of gastroretentive drug delivery systems (GRDDS). It discusses how GRDDS can prolong the gastric retention of dosage forms to target drug release in the stomach. It describes different approaches for GRDDS, including floating and non-floating systems. Floating drug delivery systems have a density less than gastric fluids and remain buoyant, while non-floating systems are retained through mechanisms like bioadhesion, unfolding designs, or high density. The document reviews the merits of GRDDS and factors affecting performance, as well as common evaluation methods and concludes that GRDDS have potential but also challenges to optimize drug absorption.
The document discusses institutional review boards (IRBs), which are charged with protecting the rights and safety of clinical trial participants. IRBs review research protocols to ensure they are ethical and risks to participants are minimized. The document outlines the composition, procedures, and functions of IRBs, including that they must have at least five members from diverse backgrounds and one community member. IRBs review research plans, consent forms, and any changes or adverse events during a study. Their goal is to uphold ethical standards for human subjects research set forth in documents like the Belmont Report.
This document discusses mini-tablets, which are small tablets between 1-3 mm in diameter that can be filled into capsules or compressed into larger tablets. Mini-tablets offer sustained or controlled drug release and reduce dosing frequency. They are prepared by compressing powder into mini-tablets, coating them for protection, and filling into capsules. Mini-tablets can provide immediate or sustained release and be used to create biphasic delivery systems. They offer benefits over other dosage forms like pellets or granules due to their uniform size, shape and coatability. The document evaluates different mini-tablet approaches and concludes they improve therapeutic outcomes and patient compliance.
1) SPRITAM is the first FDA-approved drug manufactured using 3D printing. It contains the drug levetiracetam to treat seizures in people ages 4 and up.
2) SPRITAM uses Zip Dose Technology, which combines formulation science with 3D printing capabilities to produce tablets that rapidly disintegrate in liquid.
3) There are several 3D printing methods like Fused Deposition Modeling, Stereolithography, and Selective Laser Sintering that use different materials and processes to build objects layer by layer.
This document provides an overview of the history and development of vaccine drug delivery systems. It discusses early methods of vaccination including variolation and Edward Jenner's development of the smallpox vaccine in 1796. Major developments include Louis Pasteur's attenuated vaccines in the 1880s, the creation of inactivated toxins in the 1920s, and the polio vaccines of the 1950s. Recent research focuses on new delivery systems like DNA vaccines, viral vectors, and plant vaccines. The document also examines mechanisms of antigen uptake and presentation, types of vaccines, and delivery methods like liposomes, microparticles, and oral vaccination.
The document summarizes the anatomy and physiology of the respiratory system. It describes the main functions of the respiratory system as pulmonary ventilation, external respiration for gas exchange between the lungs and bloodstream, and internal respiration for gas exchange between the bloodstream and tissues. It then details the conducting and respiratory zones, describing the structures of the nose, pharynx, larynx, trachea, bronchi, bronchioles and alveoli. It explains the mechanisms of inspiration and expiration driven by the diaphragm and intercostal muscles. Lung volumes such as tidal volume, vital capacity and functional residual capacity are also defined.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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2. Suppositories
Definition:
Suppositories are solid dosage forms intended for
insertion into body orifices (rectum, vagina, urethra)
where they melt, soften, or dissolve and exert a local
or systemic effect.
Local action:
Rectal suppositories intended for localized action are
most frequently used to relieve constipation or pain,
irritation, itching, and inflammation associated with
hemorrhoids.
3. Suppositories (cont.):
Systemic action: (e.g. Antiasthmatic, antirheumatic &
analgesic drugs).
The suppository may be ideally used in:
1- Babies or old people who cannot swallow oral
medication.
2- Post operative people who cannot be administered oral
medication.
3- People suffering from severe nausea or vomiting.
4- Drugs inactivated by the pH or enzymatic activity of the
stomach or intestine.
5- Drugs irritating to the stomach.
6- Drugs destroyed by portal circulation.
4. Suppositories (cont.):
The modern rectal suppository is a conical or torpedo
shaped item which is about 2 - 3 centimeters in length.
Suppositories for adults weigh 2 grams each and
children suppositories weigh 1 gram each.
Urethral suppositories for males weigh 4 grams each
and for females they weigh 2 grams each.
Vaginal suppositories, also called pessaries, are usually
globular (ball), oviform or cone-shaped and weigh about
5 grams.
5. Suppositories (cont.):
Anatomy and of the rectum:
- The rectum is part of the colon,
forming the last 15 – 20 cm of the GI tract.
- The rectum can be considered as a hollow
organ with a relatively flat wall surface, without
villi.
- It contains only 2 – 3 ml of inert mucous fluid
with pH of 7.5 .
6. ABSORPTION OF DRUGS
FROM THE RECTUM
3 separate veins
Lower
haemorroidal vein
Middle
haemorroidal vein
Upper
haemorroidal vein
drain directly into the general
circulation
Drains into the portal vein,
which flows to the liver
7. Suppositories (cont.):
Physiological factors affecting rectal absorption:
1- Quantity of fluid available:
The quantity of fluid available for drug dissolution is
very small (approximately 3 ml). Thus the dissolution
of slightly soluble substances is the slowest step in
the absorptive process.
2- The properties of rectal fluid:
The rectal fluid is neutral in pH (7 – 8) and has no
buffer capacity.
8. Physiological factors affecting rectal
absorption(Cont.):
3- Contents of the rectum:
When systemic effects are desired, greater absorption
may be expected from an empty rectum as the drug
will be in good contact with the absorbing surface of
the rectum.
4- Circulation route:
The lower hemorrhoidal veins surrounding the colon
receive the absorbed drug and initiate its circulation
throughout the body, bypassing the liver. Lymphatic
circulation also assists in the absorption.
9. Suppositories (cont.):
Physicochemical factors of the drug and suppository base
affecting rectal absorption:
1- Drug solubility in vehicle:
- The rate at which a drug is released from a suppository and
absorbed by the rectal mucous membrane is directly related to
its solubility in the vehicle or, in other words, to the partition
coefficient of the drug between the vehicle and the rectal
liquids.
- When drugs are highly soluble in the vehicle the
tendency to leave the vehicle will be small and so the release
rate into the rectal fluid will be low.
10. Physicochemical factors of the drug and
suppository base affecting rectal absorption
(Cont.):
Drug solubility and suppository formulation
Solubility in Choice of base
Fat Water
low high Fatty base
high low Aqueous base
low low Indeterminate
11. Physicochemical factors of the drug and
suppository base affecting rectal absorption
(Cont.):
2- Particle Size:
- For drugs present in a suppository in the undissolved
state, the size of the drug particle will influence its
rate of dissolution and its availability for absorption.
- The smaller the particle size the more readily
the dissolution of the particle the greater
chance for rapid absorption.
12. Physicochemical factors of the drug and
suppository base affecting rectal absorption
(Cont.):
3- Nature of the base:
- The base must be capable of melting, softening, or dissolving to
release its drug components for absorption.
- If the base interacts with the drug inhibiting its release
drug absorption will be impaired or even prevented.
- Also, if the base is irritating to the mucous membranes of the
rectum it may initiate a colonic response and a bowel
movement incomplete drug release and absorption.
13. Physicochemical factors of the drug and
suppository base affecting rectal absorption
(Cont.):
4- Spreading Capacity:
- The rapidity and intensity of the therapeutic effects of
suppositories are related to the surface area of the
rectal mucous membrane covered by the melted
base : drug mixture (the spreading capacity of the
suppositories). This spreading capacity may be
related to the presence of surfactants in the base.
14. Suppositories (cont.):
Suppository bases:
The properties of an ideal suppository base:
1- Melts at body temperature or dissolves in body fluids.
2- Non-toxic and non-irritant.
3- Compatible with any medicament.
4- Releases any medicament readily.
5- Easily moulded and removed from the mould.
6- Stable to heating above the melting point.
7- Easy to handle.
8- Stable on storage.
15. Suppository bases (Cont.):
Suppository bases are classified according to their
physical characteristics into:
I Fatty bases: designed to melt at body temperature.
1- Theobroma oil (Cocoa butter)
It is a yellowish-white solid with an odour of chocolate
and is a mixture of glyceryl esters of different
unsaturated fatty acids.
** Advantages:
a- A melting range of 30 - 36°C (solid at room
temperature but melts in the body).
b- Readily melted on warming, rapid setting on cooling.
c- Miscible with many ingredients.
d- Non-irritating.
16. Suppository bases (Cont.):
** Disadvantages:
a- Polymorphism:
- When melted and cooled it solidifies in different
crystalline forms, depending on the temperature of
melting, rate of cooling and the size of the mass.
- If melted at not more than 36°C and slowly cooled
it forms stable beta crystals with normal melting point.
- If over-heated then cooled it produce unstable
gamma crystals which melt at about 15°C or alpha
crystals melting at 20°C.
17. Suppository bases (Cont.):
- These unstable forms return to the stable condition
after several days.
- Cocoa butter must be slowly melted over a warm
water bath to avoid the formation of the unstable
crystalline form.
b- Adherence to the mould:
- Cocoa butter does not contract sufficiently on cooling
to loosen the suppositories in the mould.
- Sticking may be overcome by adequate lubrication.
18. Suppository bases (Cont.):
c- Softening point too low for hot climates.
d- Melting point reduced by soluble ingredients:
- Phenol and chloral hydrate have a tendency to lower
the melting point of cocoa butter.
- So, solidifying agents like beeswax (4%) may be
incorporated to compensate for the softening effect
of the added substance.
e- Rancidity on storage:
Due to the oxidation of unsaturated glycerides.
19. Suppository bases (Cont.):
f- Poor water-absorbing ability:
Improved by the addition of emulsifying agents.
g- Leakage from the body:
Sometimes the melted base escapes from the rectum
or vagina, so, it is rarely used as a pessary base.
h- Expensive
20. Suppository bases (Cont.):
2- Synthetic hard fat:
- For example: Suppocire, witepsol.
** Advantages:
a- Their solidifying points are unaffected by overheating.
b- They have good resistance to oxidation because of the lower
content of unsaturated fatty acids.
c- The difference between melting and setting points is small.
Hence they set quickly, the risk of sedimentation of suspended
ingredients is low.
d- They are marketed in a series of grades with different melting
point ranges, which can be chosen to suit particular products
and climatic condition.
21. Suppository bases (Cont.):
e- They contain a proportion of w/o emulsifying agents,
and therefore, their water-absorbing capacities are
good.
f- No mould lubricant is necessary because they
contract significantly on cooling.
** Disadvantages:
a- Brittle if cooled rapidly, avoid refrigeration during
preparation.
b- The melted fats are less viscous than theobroma oil.
As a result greater risk of drug particles to
sediment during preparation lack of uniform
drug distribution give localized irritancy.
22. Suppository bases (Cont.):
II Water-soluble and water-miscible bases:
1- Glycero-gelatin:
-The commonest is Glycerol Suppositories Base B.P., which has 14% w/w
gelatin, and 70% w/w glycerol & water Q.S. to 100%. .
- The glycerol-gelatin base U.S.P. consisted of 20% w/w gelatin, and 70% w/w
glycerol & water Q.S. to 100%.
23. Suppository bases (Cont.):
** Disadvantages:
a- A physiological effect:
osmosis occurs during dissolving in the mucous secretions of the
rectum, producing a laxative effect.
b- Can cause rectal irritation due to small amount of liquid present.
c- Unpredictable solution time.
d- Hygroscopic:
So, they should be packaged in tight containers and also have
dehydrating effects on the rectal and vaginal mucosa leading to
irritation.
e- Microbial contamination likely.
f- Long preparation time.
g- Lubrication of the mould is essential.
24. Suppository bases (Cont.):
2- Macrogols (polyethylene glycols):
- Polyethylene glycols are polymers of ethylene oxide and water,
prepared to various chain lengths, molecular weights, and
physical states.
- The numerical designations refer to the average molecular
weights of each of the polymers.
- Polyethylene glycols (PEGs) having average molecular weights of
300, 400, and 600 are clear, colorless liquids, while those with
molecular weights of 600-1000 are semisolids.
- Those having average molecular weights of greater than 1000 are
wax-like, white solids with the hardness increasing with an
increase in the molecular weight.
25. Suppository bases (Cont.):
These polyethylene glycols can be blended together to
produce suppository bases with varying: melting
points, dissolution rates and physical characteristics.
Drug release depends on the base dissolving rather
than melting.
The melting point is often around 50°C.
Higher proportions of high molecular weight polymers
produce preparations which release the drug slowly
and are also brittle.
Less brittle products which release the drug more
readily can be prepared by mixing high polymers with
medium and low polymers.
26. Suppository bases (Cont.):
** Advantages:
a- No laxative effect.
b- Less microbial contamination.
c- The base contract on cooling and no lubricant is necessary.
d- Melting point above body temperature:
- Cool storage is not so critical.
- Suitable for hot climates
- The base dissolve in the body and disperse the medication
slowly, providing a sustained effect.
e- Produce high-viscosity solutions, so leakage is less likely.
f- Good solvent properties.
27. Suppository bases (Cont.):
** Disadvantages:
a- Hygroscopic:
- Thus may cause irritation to the mucosa. This can be overcome by
instructing the patient to dip the preparation in water prior to
insertion.
b- Poor bioavailability of medicaments:
The good solvent properties may result in retention of the drug in the
liquefied base with consequent reduction in therapeutic effect.
c- Incompatibilities:
Incompatibility with several drugs and packaging materials, e.g.
benzocaine, penicillin and plastic, may limit their use.
d- Brittleness: if cooled too quickly and also on storage.
28. Suppository bases (Cont.):
3- SOAP GLYCERIN:
Obtained by : stearic acid + sodium carbonate in glycerin solution
stearin soap (i.e. curd soap, sodium stearate) (used as suppository
base).
Advantages over gelatin:
A- It makes glycerin sufficiently hard for suppositories.
B- It allows the incorporation of large quantity of glycerin up to 90-
95% of the mass.
C- Soap assists the laxative action of glycerin, whereas gelatin does
not.
Disadvantages:
Very hygroscopic & require to be wrapped in waxed paper or pure
tin foil & protected from the atmosphere.
29. Suppositories (Cont.):
Preparation of suppositories:
Suppositories are prepared by four methods:
I Hand moulding:
-Hand molding is useful when we are preparing a small number of
suppositories:
***Steps:
1. The drug is made into a fine powder.
2. It is incorporated into the suppository base by kneading with it or
by trituration in a mortar.
3. The kneaded mass is rolled between fingers into rod shaped units.
4. The rods are cut into pieces and then one end is pointed.
30. Preparation of suppositories (Cont.):
II Compression molding:
1. The cold mass of the base containing the drug is compressed
into suppositories using a hand operated machine.
**Advantages:
1.It is a simple method.
2. It gives suppositories that are more elegant than hand
moulded suppositories.
3. In this method sedimentation of solids in the base is
prevented.
4. Suitable for heat labile medicaments.
**Disadvantages:
1.Air entrapment may take place.
2.This air may cause weight variation.
3.The drug and/or the base may be oxidized by this air.
31. Preparation of suppositories (Cont.):
III Pour moulding:
- Using a supp. mould which is made of metal or
plastic.Traditional metal moulds are in two halves
which are clamped together with a screw.
Steps:
1. The base is melted and precautions are taken not to
overheat it.
2. The drug is incorporated in it.
3. The molten liquid mass is poured into chilled
(lubricated if cocoa butter or glycrogelatin is the base)
molds.
4. After solidification the cone shaped suppositories are
32. Lubricants for use with suppository
bases:
- Lubricating the cavities of the mould is helpful in
producing elegant suppositories and free from surface
depression.
- The lubricant must be different in nature from the
suppository base, otherwise it will be become absorbed
and will fail to provide a buffer film between the mass &
the metal.
- The water soluble lubricant is useful for fatty bases while
the oily lubricant is useful for water soluble bases.
- The lubricant should be applied on a pledget of gauze or
with fairly stiff brush.
33. Lubricants for use with suppository
bases:
Lubricant
Base
Soap spirit
Theobroma oil
liquid paraffin
Glycerol-gelatin base
No lubricant required
Synthetic fats
No lubricant required
Macrogols
34. Preparation of suppositories (Cont.):
IV Automatic Moulding machine:
All the operations in pour moulding are done by
automatic machines. Using this machine, up to about
10,000 suppositories per hour can be produced.
35. Suppositories (Cont.):
Packaging and storage:
-Suppositories are usually packed in tin or aluminium, paper or
plastic.
-Poorly packed suppositories may give rise to staining, breakage
or deformation by melting.
-Both cocoa butter and glycerinated gelatin suppositories stored
preferably in a refrigerator.
- Polyethylene glycol suppositories stored at usual room
temperature without the requirement of refrigeration.
36. Suppositories (Cont.):
Problems in formulation:
1- Water in suppositories:
Formulators do not like to use water for dissolving drugs in
suppositories for the following reasons :
a. Water causes oxidation of fats.
b. If the suppositories are manufactured at a high temperature, the
water evaporates, the drugs crystallize out.
c. Absorption of water soluble drugs is enhanced only if the base is
an oil – in – water emulsion with more than 50% of the water in the
external phase.
d. Drug excipient interactions are more likely to happen in the
presence of water.
e. Bacterial contamination may be a problem, so we may be forced
to add a preservative.
37. Problems in formulation (Cont.):
2- Hygroscopicity:
- Glycerogelatin suppositories lose moisture in dry climates and
absorb moisture in humid conditions.
- The hygroscopicity of polyethylene glycol bases depends on the
chain length of the molecule.
- As the molecular weight of these ethylene oxide polymers
increases
the hygroscopicity decreases
38. Problems in formulation (Cont.):
3- Drug-excipient interactions:
- Incompatibilities exist between polyethylene glycol base and
some drugs.
- Sodium barbital and salicylic acid crystallize out of polyethylene
glycol.
- High concentrations of salicylic acid soften polyethylene glycol
to an ointment like consistency.
- Penicillin G is stable in cocoa butter and other fatty bases. It
decomposes in polyethylene glycol bases.
39. Problems in formulation (Cont.):
4- Viscosity:
- When the base has low viscosity, sedimentation of the drug is a problem.
- 2% aluminium monostearate may be added to increase the viscosity of
the base.
- Cetyl and stearyl alcohols or stearic acid are added to improve the
consistency of suppositories.
5- Brittleness:
-Cocoa butter suppositories are elastic, not brittle.
- Synthetic fat bases are brittle.
- This problem can be overcome by keeping the temperature difference
between the melted base and the mold as small as possible.
- Materials that impart plasticity to a fat and make them less brittle are small
amounts of Tween 80, castor oil, glycerin or propylene glycol.
40. Problems in formulation (Cont.):
6-Density:
Density of the base, the drug, the volume of the mould
and whether the base is having the
property of volume contraction are all important. They
all determine the weight of the suppository.
7- Lubrication of moulds:
Some widely used lubricating agents are mineral oil,
aqueous solution of SLS, alcohol and tincture of green
soap. These are applied by wiping, brushing or spraying.
41. Problems in formulation (Cont.):
8- Volume contraction:
- On solidification the volume of the suppository decreases. The
mass of the suppository pulls away from the sides of the mould.
This contraction helps the
suppository to easily slip away from the mould, preventing the
need for a lubricating agent.
- Sometimes when the suppository mass is contracting, a hole
forms at the open end. This gives an inelegant appearance to
the suppository. Weight variation among suppositories is also
likely to occur.
- This contraction can be minimized by pouring the suppository
mass slightly above its congealing temperature
into a mould warmed to about the same temperature. Another
way to overcome this problem is to overfill the molds, and
scrape off the excess mass which contains the contraction hole.
42. Problems in formulation (Cont.):
9- Displacement value:
- The displacement value may be defined as , the
number of parts by weight of medicament that
displaces one part by weight of the base.
- The volume of suppositories from a particular mould
will be constant but the weight will vary because the
densities of the medicaments usually differ from the
density of the base, and hence the density of the
medicament will affect the amount of the base
required for each suppository.
43. Problems in formulation (Cont.):
10- Weight and volume control:
-Various factors influence the weight of the suppository, the volume of
the suppository and the amount of active ingredient in each suppository :
They are:
1. Concentration of the drug in the mass
2. Volume of the mould cavity
3. The specific gravity of the base
4. Volume variation between moulds
5. Weight variation between suppositories due to the inconsistencies in
the manufacturing process.
- The upper limit for the weight variation in suppositories is 5%.
44. Problems in formulation (Cont.):
11- Rancidity :
- The unsaturated fatty acids in the suppository bases
undergo auto oxidation and decompose into
aldehydes, ketones and acids. These products have
strong, unpleasant odours.
- The lower the content of unsaturated fatty acids in a
base, the higher is its resistance to rancidity.
45. Suppositories (Cont.):
Quality control of suppositories:
1- Appearance:
This includes odour, colour, surface condition and shape.
2- Weight Uniformity:
- Weigh 20 suppositories individually. w1, w2, w3….w20
- Weigh all the suppositories together = W.
- Calculate the average weight = W/20.
Limit: Not more than 2 suppositories differ from the average
weight by more than 5%, and no suppository differs
from the average weight by more than 10%.
46. Suppositories (Cont.):
3- Melting range test:
- Determines the time taken by an entire suppository to melt when it is
immersed in a constant temperature bath at 37°C.
-The experiment done by using the USP Tablet Disintegration Apparatus.
Procedure:
1-The suppository is completely immersed in the constant temperature water
bath, and the time for the entire suppository to melt or disperse in the
surrounding water is measured.
- The suppository is considered disintegrated when:
A- It is completely dissolved or
B- Dispersed into its component part.
C- Become soft “change in shape” with formation of core which is not
resistant to pressure with glass rod.
47. Quality control of suppositories (Cont.)
4- Liquefaction Time or Softening Time Test:
- In this test a U tube is partially immersed in a constant temperature
bath and is maintained at a temperature between 35 to 37°C.
There is a constriction in the tube in which the suppository is kept
and above the suppository, a glass rod is kept. The time taken for
the
glass rod to go through the suppository and reach the constriction
is known as the liquefaction time or softening time.
- Another apparatus is there for finding “softening time” which
mimics in vivo conditions. It uses a cellophane tube, and the
temperature is maintained by water circulation. Time taken for the
suppository to melt is noted.
48. Quality control of suppositories (Cont.)
5- Breaking Test (Hardness):
- The breaking test is designed as a method for measuring the
fragility or brittleness of suppository.
1-The suppository is placed in the instrument.
2- Add 600 g; leave it for one min. (use a stop watch).
3- If not broken, add 200 g every one min. until the
suppository is broken.
Calculations:
The hardness of the suppository is calculated by
adding the weights together.
But if the suppository is broken before the end
of the last min. the last weight is canceled.
-
49. Quality control of suppositories (Cont.)
6- Dissolution test:
- By using different types of apparatus such as wire
mesh basket, or dialysis tubing is used
to test for in vitro release from suppositories.
50. Quality control of suppositories (Cont.)
7- Stability testing:
-Cocoa butter suppositories on storage, “bloom”; i.e., they form a white
powdery deposit on the surface. This can be avoided by storing the
suppositories at uniform cool temperatures and by wrapping them in foils.
- Fat based suppositories harden on storage, i.e., there is an upward shift in
melting range due to slow crystallization to the more stable polymorphic forms
of the base.
- The softening time test and differential scanning calorimetry can be used as
stability indicating test methods.
- If we store the suppositories at an elevated temperature, just below its
melting range, immediately after manufacture, the aging process is speeded
up.