This document provides an overview of vehicles used in skin cosmetics and their functions. It discusses main vehicle types including emulsions, gels, microemulsions and nanoparticles. Emulsions are the most commonly used vehicle and can be oil-in-water or water-in-oil emulsions. The document describes the composition and properties of different emulsion types. It also covers hydrogels, lipogels, multiple emulsions and emerging vehicles like solid lipid nanoparticles. The vehicle plays a key role in delivering active ingredients and achieving the desired cosmetic effect.
The document discusses suspensions, which are heterogeneous systems with small, solid particles dispersed throughout a liquid medium. Suspensions can be used orally, parenterally, or externally. They are divided into coarse and colloidal suspensions based on particle size. Various factors including particle size and distribution, viscosity, and stability must be considered for suspension formulation and production. Common methods for preparing suspensions involve using mortar and pestle or mixing equipment depending on the materials used.
This document provides an overview of semi-solid dosage forms. It defines semi-solids as products that tend to alleviate or treat pathological conditions when applied to the skin or mucous membranes. Ideal properties include a smooth texture, elegant appearance, and non-irritating qualities. Common types are ointments, creams, pastes, gels, and suppositories. Formulation involves selecting appropriate bases, preservatives, and other excipients. Methods of preparation include size reduction, levigation, mixing, homogenization, and filling. Evaluation tests physical properties, drug release, and stability.
Capsules are solid dosage forms that enclose medicinal substances within a small gelatin shell. There are two main types of gelatin capsules: hard capsules, which consist of a body and cap, and soft capsules, which have a softer shell. Capsules offer advantages like masking unpleasant tastes, allowing powders to dissolve quickly, and providing flexibility in dosing. They are filled by preparing a formulation that may include active ingredients, diluents, lubricants, and glidants. The powder is then filled into capsule shells of appropriate sizes and polished.
cosmetic and cosmeceutical
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas without contamination. Aerosols consist of a propellant, container, valve, and product concentrate. Common propellants include hydrocarbons and gases. Containers must withstand high pressure and are often metal or glass. Valves meter doses and come in types like spray or foam. Formulations contain an active ingredient and propellant to achieve desired properties. Quality is ensured through testing of components, dosage, leakage and other parameters.
This document discusses various pharmaceutical calculations related to dispensing medications. It covers:
- Systems of weights and measures including avoirdupois, apothecaries, metric, and imperial.
- Calculations involving density, weight, and volume.
- Methods for calculating alcohol dilutions and mixtures to achieve a target concentration.
- Conversions between percentage solutions and proof spirit units used for excise purposes.
The document provides detailed examples and step-by-step workings for various calculation types pharmacists may encounter when dispensing prescriptions.
This document discusses semisolid dosage forms used for therapeutic or cosmetic purposes. It describes various types of semisolids - ointments, creams, pastes, gels - and their characteristics. It also outlines different bases used for semisolids like oleaginous bases, absorption bases, water-in-oil and oil-in-water emulsion bases, and water soluble bases. Key factors in selecting the appropriate base for a semisolid are also summarized.
The document discusses suspensions, which are heterogeneous systems with small, solid particles dispersed throughout a liquid medium. Suspensions can be used orally, parenterally, or externally. They are divided into coarse and colloidal suspensions based on particle size. Various factors including particle size and distribution, viscosity, and stability must be considered for suspension formulation and production. Common methods for preparing suspensions involve using mortar and pestle or mixing equipment depending on the materials used.
This document provides an overview of semi-solid dosage forms. It defines semi-solids as products that tend to alleviate or treat pathological conditions when applied to the skin or mucous membranes. Ideal properties include a smooth texture, elegant appearance, and non-irritating qualities. Common types are ointments, creams, pastes, gels, and suppositories. Formulation involves selecting appropriate bases, preservatives, and other excipients. Methods of preparation include size reduction, levigation, mixing, homogenization, and filling. Evaluation tests physical properties, drug release, and stability.
Capsules are solid dosage forms that enclose medicinal substances within a small gelatin shell. There are two main types of gelatin capsules: hard capsules, which consist of a body and cap, and soft capsules, which have a softer shell. Capsules offer advantages like masking unpleasant tastes, allowing powders to dissolve quickly, and providing flexibility in dosing. They are filled by preparing a formulation that may include active ingredients, diluents, lubricants, and glidants. The powder is then filled into capsule shells of appropriate sizes and polished.
cosmetic and cosmeceutical
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas without contamination. Aerosols consist of a propellant, container, valve, and product concentrate. Common propellants include hydrocarbons and gases. Containers must withstand high pressure and are often metal or glass. Valves meter doses and come in types like spray or foam. Formulations contain an active ingredient and propellant to achieve desired properties. Quality is ensured through testing of components, dosage, leakage and other parameters.
This document discusses various pharmaceutical calculations related to dispensing medications. It covers:
- Systems of weights and measures including avoirdupois, apothecaries, metric, and imperial.
- Calculations involving density, weight, and volume.
- Methods for calculating alcohol dilutions and mixtures to achieve a target concentration.
- Conversions between percentage solutions and proof spirit units used for excise purposes.
The document provides detailed examples and step-by-step workings for various calculation types pharmacists may encounter when dispensing prescriptions.
This document discusses semisolid dosage forms used for therapeutic or cosmetic purposes. It describes various types of semisolids - ointments, creams, pastes, gels - and their characteristics. It also outlines different bases used for semisolids like oleaginous bases, absorption bases, water-in-oil and oil-in-water emulsion bases, and water soluble bases. Key factors in selecting the appropriate base for a semisolid are also summarized.
This document discusses quality control tests for topical preparations, including transdermal drug delivery systems (TDDS). It describes various types of topical preparations like creams, ointments, gels, pastes, and jellies. It also discusses the common ingredients in TDDS like drugs, liners, adhesives, permeation enhancers, backing layers, and polymer matrices. Finally, it outlines the key physicochemical tests performed for quality control of TDDS, including thickness, weight uniformity, drug content, content uniformity, moisture content, and moisture uptake testing.
This document discusses solutions and provides information on:
- The three types of solutions - solid, liquid, and gaseous solutions depending on whether the solvent is solid, liquid, or gas.
- Factors that affect the rate of solubility such as particle size, agitation, and temperature.
- Factors that affect the solubility of a solute such as temperature, molecular structure, effects of other substances, and pH.
- Examples of oral solutions from different categories such as antidepressants, bronchodilators, antipsychotics, and vitamins.
- Characteristics and preparation methods of aqueous solutions and aromatic waters.
1. The document discusses liquid dosage forms, which provide advantages over solid forms like faster absorption.
2. Liquid dosage forms are classified as monophasic containing one phase like syrups, or biphasic containing two phases like suspensions and emulsions.
3. Key liquid dosage forms are described including their composition, preparation, and uses both internally and externally. Advantages and disadvantages of liquid dosage forms are also outlined.
This document discusses dissolution testing, which involves measuring how quickly a solid drug substance dissolves in solution. It defines dissolution and factors that affect the rate. These include drug properties like solubility, particle size, and solid form, as well as dosage form properties and excipients. Common in vitro dissolution testing models are described, including basket, paddle, and flow-through methods. Acceptance criteria for dissolution testing and methods for comparing dissolution profiles are also summarized.
This document provides information on creams as a semisolid dosage form. It begins by defining creams and describing the two main types: oil-in-water (O/W) and water-in-oil (W/O) emulsions. The uses and manufacturing process of creams are then outlined. The document also includes details on specific types of creams, formulations, quality control testing using vertical diffusion cell methods, and concludes with a case study example of a betamethasone cream.
The document describes different types of tablets classified by method of administration and mechanism of action. Tablets can be ingested orally and include standard, enteric coated, chewable and effervescent varieties. Others are used in the oral cavity as buccal, sublingual or lozenges. Implantation and vaginal tablets are administered by other routes. Tablet types aim to protect drugs, modify release timing, or produce solutions for various therapeutic effects.
This document discusses isotonic solutions and how to calculate concentrations needed for isotonicity. A 0.9% sodium chloride solution is isotonic with blood plasma. Solutions with higher sodium chloride concentrations are hypertonic, and those with lower concentrations are hypotonic. The document outlines several methods to calculate concentrations of substances needed to achieve isotonicity based on freezing point depression, molecular concentration, vapor pressure graphs, and sodium chloride equivalents. Parenteral preparations should generally be isotonic, while other routes like subcutaneous may not require isotonicity.
An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication
EXCIPIENTS USED IN LIQUID DOSAGE FORMS:
Solvents/co-solvents ,
Buffering agents,
Preservatives,
Anti-oxidants,
Humectants,
Wetting agents,
Anti-foaming agents,
Thickening agents,
Sweetening agents,
Flavouring agents,
EXCIPIENTS USED IN TABLETS:
Binders
Coatings
Disintegrants
Fillers
Flavours
Colours
Lubricants
Glidants
Preservatives
Sweeteners
This document provides an overview of aerosols for pharmaceutical use. It begins with introductions to aerosols and pharmaceutical aerosols. The main components of aerosols are then described, including propellants, containers, valves, and actuators. Various aerosol systems like solution, suspension, and foam systems are also outlined. The document concludes with sections on the formulation, manufacturing, and quality control of pharmaceutical aerosols.
CREAMS MS.WAJIHA IFFAT
OBJECTIVES:
After the end of this topic, the student will be able to :
-->Define creams
-->Classify creams
--->Method of preparation
--->prepare a cream from first principles
incorporate solids and liquids into a cream base
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document discusses liquid dosage forms, including their classification and composition. It begins by defining liquid dosage forms and describing their monophasic and biphasic forms. It then classifies common liquid dosage forms for internal and external use, such as syrups, elixirs, linctuses, drops, liniments, and lotions. The document describes the composition and preparation of various liquid dosage forms. It concludes by discussing the advantages and disadvantages of liquid dosage forms and describing common additives used in liquid formulations such as vehicles, buffers, and preservatives.
This document discusses semisolid dosage forms, which are dermatological preparations intended for external application to the skin to produce local or systemic effects. It describes different types of semisolid dosage forms including ointments, creams, pastes, gels, jellies, poultices, and suppositories. For each type, it covers their physical and physiological properties, common applications, advantages and disadvantages, examples of medicated formulations, and other key details. The document is intended to provide an overview of semisolid dosage forms for dermatological use.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Cold creams are oil-in-water emulsions used to smooth skin and remove makeup. They produce a cooling effect due to the slow evaporation of water. Common ingredients include beeswax, mineral oils, and scents. Cold creams were traditionally made from animal fats but now use vegetable and mineral oils. When applied, the emulsion inverts from oil-in-water to water-in-oil. Cleansing creams are similar but contain detergents to clean the skin by removing dirt, oil, and dead cells in addition to makeup. Vanishing creams are oil-in-water emulsions that leave a thin, almost invisible layer of stearic acid on the skin.
it is a complete overview on ophthalmic dosage form. beginning from anatomy and physiology of eye with drug absorption mechanism including all factors to formulation considerations and evaluation of the products i.e. eye drops and eye ointment & the evaluation tests. it will help you make the concepts clear about ophthalmic drug deliveries.
Ointment, cream, gel , pastes, plasters, glycerogelatinCristina Joy Reyes
Ointments, creams, gels, pastes, plasters, and glycerogelatins are different topical semisolid dosage forms. Ointments are semisolids for application to the skin or mucous membranes and can be medicated or unmedicated. Creams are emulsions that can be water-in-oil or oil-in-water. Gels are dispersions of molecules in an aqueous liquid made jelly-like with a gelling agent. Pastes are stiffer than ointments and contain more solids. Plasters are adhesive solid or semisolid masses spread on a backing. Glycerogelatins contain gelatin, glycerin, water,
Discussion on the 2 kinds of Disperse Systems 1. Suspensions 2. Emulsions. The principles of emulsification, types and examples of emulsifying agents used.
This document discusses quality control tests for topical preparations, including transdermal drug delivery systems (TDDS). It describes various types of topical preparations like creams, ointments, gels, pastes, and jellies. It also discusses the common ingredients in TDDS like drugs, liners, adhesives, permeation enhancers, backing layers, and polymer matrices. Finally, it outlines the key physicochemical tests performed for quality control of TDDS, including thickness, weight uniformity, drug content, content uniformity, moisture content, and moisture uptake testing.
This document discusses solutions and provides information on:
- The three types of solutions - solid, liquid, and gaseous solutions depending on whether the solvent is solid, liquid, or gas.
- Factors that affect the rate of solubility such as particle size, agitation, and temperature.
- Factors that affect the solubility of a solute such as temperature, molecular structure, effects of other substances, and pH.
- Examples of oral solutions from different categories such as antidepressants, bronchodilators, antipsychotics, and vitamins.
- Characteristics and preparation methods of aqueous solutions and aromatic waters.
1. The document discusses liquid dosage forms, which provide advantages over solid forms like faster absorption.
2. Liquid dosage forms are classified as monophasic containing one phase like syrups, or biphasic containing two phases like suspensions and emulsions.
3. Key liquid dosage forms are described including their composition, preparation, and uses both internally and externally. Advantages and disadvantages of liquid dosage forms are also outlined.
This document discusses dissolution testing, which involves measuring how quickly a solid drug substance dissolves in solution. It defines dissolution and factors that affect the rate. These include drug properties like solubility, particle size, and solid form, as well as dosage form properties and excipients. Common in vitro dissolution testing models are described, including basket, paddle, and flow-through methods. Acceptance criteria for dissolution testing and methods for comparing dissolution profiles are also summarized.
This document provides information on creams as a semisolid dosage form. It begins by defining creams and describing the two main types: oil-in-water (O/W) and water-in-oil (W/O) emulsions. The uses and manufacturing process of creams are then outlined. The document also includes details on specific types of creams, formulations, quality control testing using vertical diffusion cell methods, and concludes with a case study example of a betamethasone cream.
The document describes different types of tablets classified by method of administration and mechanism of action. Tablets can be ingested orally and include standard, enteric coated, chewable and effervescent varieties. Others are used in the oral cavity as buccal, sublingual or lozenges. Implantation and vaginal tablets are administered by other routes. Tablet types aim to protect drugs, modify release timing, or produce solutions for various therapeutic effects.
This document discusses isotonic solutions and how to calculate concentrations needed for isotonicity. A 0.9% sodium chloride solution is isotonic with blood plasma. Solutions with higher sodium chloride concentrations are hypertonic, and those with lower concentrations are hypotonic. The document outlines several methods to calculate concentrations of substances needed to achieve isotonicity based on freezing point depression, molecular concentration, vapor pressure graphs, and sodium chloride equivalents. Parenteral preparations should generally be isotonic, while other routes like subcutaneous may not require isotonicity.
An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication
EXCIPIENTS USED IN LIQUID DOSAGE FORMS:
Solvents/co-solvents ,
Buffering agents,
Preservatives,
Anti-oxidants,
Humectants,
Wetting agents,
Anti-foaming agents,
Thickening agents,
Sweetening agents,
Flavouring agents,
EXCIPIENTS USED IN TABLETS:
Binders
Coatings
Disintegrants
Fillers
Flavours
Colours
Lubricants
Glidants
Preservatives
Sweeteners
This document provides an overview of aerosols for pharmaceutical use. It begins with introductions to aerosols and pharmaceutical aerosols. The main components of aerosols are then described, including propellants, containers, valves, and actuators. Various aerosol systems like solution, suspension, and foam systems are also outlined. The document concludes with sections on the formulation, manufacturing, and quality control of pharmaceutical aerosols.
CREAMS MS.WAJIHA IFFAT
OBJECTIVES:
After the end of this topic, the student will be able to :
-->Define creams
-->Classify creams
--->Method of preparation
--->prepare a cream from first principles
incorporate solids and liquids into a cream base
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
This document discusses liquid dosage forms, including their classification and composition. It begins by defining liquid dosage forms and describing their monophasic and biphasic forms. It then classifies common liquid dosage forms for internal and external use, such as syrups, elixirs, linctuses, drops, liniments, and lotions. The document describes the composition and preparation of various liquid dosage forms. It concludes by discussing the advantages and disadvantages of liquid dosage forms and describing common additives used in liquid formulations such as vehicles, buffers, and preservatives.
This document discusses semisolid dosage forms, which are dermatological preparations intended for external application to the skin to produce local or systemic effects. It describes different types of semisolid dosage forms including ointments, creams, pastes, gels, jellies, poultices, and suppositories. For each type, it covers their physical and physiological properties, common applications, advantages and disadvantages, examples of medicated formulations, and other key details. The document is intended to provide an overview of semisolid dosage forms for dermatological use.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Cold creams are oil-in-water emulsions used to smooth skin and remove makeup. They produce a cooling effect due to the slow evaporation of water. Common ingredients include beeswax, mineral oils, and scents. Cold creams were traditionally made from animal fats but now use vegetable and mineral oils. When applied, the emulsion inverts from oil-in-water to water-in-oil. Cleansing creams are similar but contain detergents to clean the skin by removing dirt, oil, and dead cells in addition to makeup. Vanishing creams are oil-in-water emulsions that leave a thin, almost invisible layer of stearic acid on the skin.
it is a complete overview on ophthalmic dosage form. beginning from anatomy and physiology of eye with drug absorption mechanism including all factors to formulation considerations and evaluation of the products i.e. eye drops and eye ointment & the evaluation tests. it will help you make the concepts clear about ophthalmic drug deliveries.
Ointment, cream, gel , pastes, plasters, glycerogelatinCristina Joy Reyes
Ointments, creams, gels, pastes, plasters, and glycerogelatins are different topical semisolid dosage forms. Ointments are semisolids for application to the skin or mucous membranes and can be medicated or unmedicated. Creams are emulsions that can be water-in-oil or oil-in-water. Gels are dispersions of molecules in an aqueous liquid made jelly-like with a gelling agent. Pastes are stiffer than ointments and contain more solids. Plasters are adhesive solid or semisolid masses spread on a backing. Glycerogelatins contain gelatin, glycerin, water,
Discussion on the 2 kinds of Disperse Systems 1. Suspensions 2. Emulsions. The principles of emulsification, types and examples of emulsifying agents used.
This document provides information about ointment as a semisolid dosage form. It defines ointments as semisolid preparations intended for external application with properties that allow them to cling to the application surface. The document discusses the composition of ointments including their bases, which can be oleaginous, absorption, water removable, or water soluble. It also covers the advantages and disadvantages of ointments as well as methods for their preparation, including incorporation and fusion methods. The selection of an appropriate base depends on factors like desired drug release and stability.
This document provides an overview of pharmaceutical emulsions. It defines emulsions as dispersions of one liquid in another immiscible liquid, stabilized by an emulsifying agent. The key topics covered include the classification of emulsions as oil-in-water or water-in-oil, theories of emulsification, common emulsifying agents like surfactants and hydrocolloids, and factors affecting the stability of emulsions such as flocculation and creaming. Pharmaceutical applications of emulsions include lotions, creams, and ointments.
This document discusses semi-solid pharmaceutical preparations, including their functions, ideal properties, and common types. It provides details on creams, ointments, gels, pastes, and other semi-solid dosage forms. The key ingredients used in formulating these preparations are also outlined, including bases, preservatives, emulsifiers, and others. Finally, common methods for preparing semi-solid dosage forms like fusion, emulsification, and trituration are briefly described.
The document discusses novel semisolid dosage forms intended for topical application. It describes various types of novel semisolids including ointments, creams, gels, and their advantages over traditional formulations. Specific examples include controlled release gels, organogels, extended release gels, amphiphilic gels, and bioadhesive gels. The document also discusses various physical means to enhance transdermal drug delivery such as phonosoresis, iontophoresis, and electrophoresis. Lastly, it provides examples of novel advances in semisolid applications for nasal and ocular drug delivery.
1. The document discusses pharmaceutical emulsions, including definitions, classification, theories of emulsification, additives, and manufacturing methods.
2. Key topics covered include the classification of emulsions as oil-in-water or water-in-oil, factors that influence emulsion stability such as particle size and creaming, and common emulsifying agents like surfactants and hydrocolloids.
3. Methods for manufacturing emulsions on small and large scales are presented, such as the 4:2:1 extemporaneous method and use of a hand homogenizer to reduce droplet size.
Emollient and Rheological Additive.pptxPrachi Pandey
Topical emollients are creams, lotions, or ointments that contain ingredients that soothe and soften the skin. The word emollient means a preparation that softens the skin. Another name for an emollient is a moisturizer.
An emulsion is a two-phase system with one liquid dispersed as globules in another liquid, requiring a surfactant and energy to join the phases. Emulsions can be oil-in-water or water-in-oil. Common surfactants include anionic, cationic, nonionic, and proteins. Emulsions are thermodynamically unstable and surfactants help slow their breakdown over time. Factors like emulsifier choice, phase ratio, temperature, and processing method impact emulsion stability and type.
Different types of solutions are use in contact lens practice. Some solutions are only for hydrophobic rigid contact lenses and some for hydrogel soft contact lenses. While few of them may be used for both types of lenses. Various solutions available can be grouped as follow:
• Wetting agents
• Cleaning agents
• Storage (soaking agents)
• Rewetting agents
Multifunctional solutions are combination of two or more of the above solutions that enhance compliance by reducing number of solutions the pt has to use.
Components of solutions
All solutions contain certain components that are peculiar to particular function of the solution at varying concentration.
Cleaning agent
Buffering agent
Vehicle
Surfactant cleaner
Enzymatic cleaner
Soaking solution
Heat for disinfection
Chemical disinfecting
Preservatives
Preservative conc. is usually low in CL solutions in order to reduce risk of any eye irritation.
Range of preservatives includes:
Benzalkonium chloride
Chlorobutanol
Thiomesal
Chlorhexidine
Ethylene diamine tetra-acetic acid (EDTA)
Sorbic acid
Potassium sorbate
1. Wetting solution
An agent that coats the contact lens with a film intends to minimize the friction of CL against pelpebral conjunctiva and cornea. It act as
buffer
Cushioning agent
It disintegrates to be replaced by lacrimal fluid. It must meet standards as regard to sterility, isotonicity, nonirritabilty and stability.
Should be buffered at pH of tears.
Essential characteristics of a Wetting agent
1. Wet thoroughly and spread over an entire surface of lens, rendering it hydrophilic.
2. Should form a film sufficiently tenacious so that it’ll not be washed away during the wearing period by tears.
3. Nonirritating and nonsensitizing
4. No residue existence (pure)
5. Cleaner, antiseptic and self-preserving
6. Viscous
7. Lubricant and preserving agent
8. Allow lens sticking on fingertip during insertion and sallow no oil of finger to get on lens
Not interfere with wetting
This document provides information about semi-solid dosage forms including ointments. It defines semi-solid dosage forms as products of semi-solid consistency applied to the skin or mucous membranes. Ointments are described as viscous semisolids used topically containing a drug and a base. Various types of bases are discussed including oleaginous, absorption, emulsion and water-soluble bases. Properties, examples and uses of different bases are provided. Other topics covered include ideal properties of semi-solid dosage forms, drug permeability through skin, and formulation ingredients like antimicrobial preservatives.
Semi solid dosage forms by ankita yagnikAnkita Yagnik
This document provides information about semi-solid dosage forms. It defines semi-solid dosage forms as products of semi-solid consistency applied to skin or mucous membranes. It notes they may contain therapeutic agents or be non-medicated. The document discusses various semi-solid dosage forms including ointments, creams, gels, pastes, foams, suppositories, plasters and powders. It provides details on drug permeability through skin and formulation of semi-solid dosage forms, discussing ingredients, bases, and examples of APIs used. The ideal properties of bases and different types of bases are also outlined.
Modern emollients include petrolatum, zinc oxide, paraffin, mineral oil, glycerin, beeswax, olive oil, coconut oil, lanolin, cocoa butter, and such synthetics as butyl stearate and diglycol laurate.
Experience and resourcesful Pharmacist with years of expertise in prescription review, medication processing and dispensing. Skilled in effectively coordinating with pharmacy staff to prioritize urgent request while ensuring accuracy, safety and maintaining patient information confidentiality. A proficient communicator, adept at collaborating closely with staff, patients, administrator and health care professionals. Currently seeking a challenging position within a progressive organization that allows me to contribute my skills toward achieving objectives while continuously developing and enhancing my professional abilities.
This document provides information about an emulsion and cream lab assignment for pharmacy students. It includes the names and student details of 5 students assigned to the topic. It then provides detailed information about emulsions and creams, including definitions, types, ingredients, preparation methods, applications, and ideal characteristics. The key topics covered are oil-in-water and water-in-oil emulsions, emulsifying agents, stabilization theories, microemulsions, phase separation, and classifications and uses of pharmaceutical creams.
This document discusses semisolid dosage forms, including their definition, ideal properties, types, mechanisms of drug penetration, and factors influencing penetration. It defines semisolid dosage forms as dermatological products of semisolid consistency applied to the skin. The main types discussed are ointments, creams, pastes, and gels. It also covers the rheological and hydrophilic properties of various semisolid bases and how these properties influence drug delivery and consistency.
Pharmaceutical Emulsions are thermodynamically unstable mixtures of two immiscible liquids stabilized by an emulsifying agent. They can be oil-in-water (O/W) or water-in-oil (W/O) emulsions depending on the dispersed and continuous phases. Emulsifying agents like surfactants, hydrocolloids, and solid particles form protective films around droplets and increase viscosity to prevent coalescence. Stability issues include creaming, cracking, and phase inversion. Methods to enhance stability are reducing droplet size, increasing viscosity, using emulsifying agents, and controlling storage temperature.
An emulsion is a dispersion of one liquid in another in which globules of one liquid are dispersed throughout the other liquid. The document discusses various topics related to emulsions including definitions, types, theories, additives, methods of preparation, testing, stability, and applications. Large scale methods for manufacturing emulsions include stirrers, homogenizers, and colloid mills which reduce droplet size through various mechanical means like high pressure homogenization. Small scale methods include mixing oil and water directly by hand shaking or using handheld homogenizers. Factors like emulsifier type and concentration, energy input, and temperature control affect emulsion properties and stability over time.
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
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Skin cosmetics & vehicles
1. CHAPTER
Skin Cosmetics & Vehicles
Subject: Industrial Pharmacy-IV
PreparedBy:
SOYKOT KHAN
(in the main role)
TITU CHANDRA SARKER
(as collaborators)
1
2. Main Cosmetic Vehicles
• The active principle is embedded into a matrix, the
vehicle.
• With the aid of the vehicle the active principle is
delivered to the application site or to the target organ,
respectively, where the desired effect is achieved.
• An effect is achieved by a cosmetic preparation—not
any systemic or central or curative effect—but a caring or
preventing effect mainly on skin, hair, or nails.
• This effect may be achieved either by cosmetically
active ingredients or by the vehicle itself on the site of
application, i.e., on the skin in most cases.
• In contrast to pharmaceutics, in cosmetics the vehicle is
of greater importance
2
3. FUNCTION OF VEHICLES
• Cleansing: hairs, e.g., shampoo, depilatory agents, hair
colorant
• Decoration: nails, e.g., polish, lacquer
• Care: mouth, e.g., toothpaste, lipstick, lip-protection
stick
• Hydration: skin, e.g., moisturizing product, body lotion,
aftershave, deodorant, antiperspirant
• Protection
CLASSIFICATION SYSTEMS OF VEHICLES
• Appearance
• Application,
Use
• Physical Chemical
3
4. Junginger’s Physical-Chemical Classification System
• Liquid systems
• Monophasic systems
• Aqueous solutions
• Alcoholic, alcoholic-aqueous solutions
Oily systems
Solutions based on (mixtures of) liquid lipids as solvent, e.g., oils for
massage
Micellar systems
Solubilisates of low soluble substances due to aggregation formation of
surfactants in solution
Micro emulsions
Optically isotropic liquid: gel composed of water, lipid, and surfactant in
distinct ratio
Multiphasic liquid systems
0/W emulsions
W/O emulsions 4
4
5. Semisolid systems
Water-free systems, ointments
Apolar systems, hydrocarbon gels (Petrolatum)
Polar systems
Polar systems without surfactants
Lipogels (E.g., hydrogenated vegetable oils),
Oleogels (Colloidal silica ¡n oils)
Polyethylene glycol gels
Polar systems with surfactants
W/O absorption bases
Simple ointment: emulsifying system (cetostearyl alcohol,
wool fat) in paraffin-petrolatum base
0/W absorption bases
Cetomacrogol emulsifying ointment: cetomacrogol 600,
cetostearyl alcohol in paraffin petrolatum base
5
6. Water-containing systems
Monophasic systems: hydrogels
• Hydrogels with inorganic gelating agents Colloidal silica in water (high
concentration,
• labile gel structure)
• Hydrogels with organic gelating agents Hydroxyethylcellulose gel,
Polyacrylate gel
Multiphasic water-containing systems: creams
• 01W creams
• W/0 creams
Amphiphilic systems
• Amphiphilic systems with crystalline gel matrix: Mesophases (liquid
crystal structures)
Liposomes (Phospholipid vesicles in aqueous medium)
Niosomes (Nonionic surfactant vesicles (analogous to liposomes) in
aqueous medium
High-concentrated suspensions, pastes , Powders
6
7. TABLE 2 Definitions of Selected Vehicle Systems
• Systems
Aerosol : Dispersion of liquid or solid in gas.
Colloidal : Colloidal systems are dispersions with particle
size range of l—500 nm.
They may be classified into the following three groups:
1. Lyophilic colloids: particles interact with the dispersion
medium (e.g.. gelatin)
2. Lyophobic colloids: composed of materials that have
little attraction (e.g., gold in water)
3. Association colloids: amphiphiles or surfactive agents
aggregated to mi celles 141.
Dispersion: Dispersed systems consist of particulate
matter (dispersed phase) distributed throughout a
continuous, or dispersion. medium [5]
7
8. Emulsion: According to LUPAC (International Union of Pure and Applied
Chemistry), emulsion is defined as liquid droplets and/or fluid crystals dispersed
in a liq uid. The dispersed phase is also called the internal phase. in contrast to
the external or continuous phase. If the internal phase is lipophilic. e.g., vegeta
ble oil or paraffin oil, and dispersed in the external hydrophilic aqueous phase.
an emulsion of type 01W is obtained. On the other hand, there are WIO
emulsions with the hydrophilic aqueous phase dispersed in the continu ous
lipophilic phase. For formation and stabilization of emulsions. emulsifi ers are
required. Emulsions may show liquid or semisolid consistency. Fur ther related
aspecis are treated in p. 151.
Foam: Dispersion of gas in liquid phase, i.e., structure of air pockets enclosed
within thin films of liquid, stabilized by a foaming agent 161.
GEL: A gel is a solid or semisolid system of at least two constituents, consisting
of a condensed mass enclosing and interpenetrated by a liquid (7J.
Solution: A true solution is defined as a mixture of two or more components
that form a homogeneous molecular dispersion. a one-phase system (8j.
Suspension: A suspension is a coarse dispersion in which insoluble solid
particles are dispersed in a liquid medium (9J.
8
9. In a physical chemical classification system, various
characterization criteria are used for classification of
the vehicles:
• Polarity: hydrophilicity, lipophilicity
• State of matter: solid, semisolid, liquid, gaseous
• Size/dimensions of particu lates dispersed in the
mixtures (dispersions) true solution, molecular dispersion:
particle size 1 nm colloidal dispersion: particle size 1 n m—
500 nm coarse dispersion: particle size 500 nm
• Solubility characteristics
• Rheology, viscosity
Composition: physical chemical characteristics of the
main vehicle
• components, water free, oily, aqueous, hydrophilic,
nonaqueous solvents
9
10. Emulsions: Lotions and Creams
Out of the range of cosmetic care products, the emulsion is the form
that ¡s probably the most used.
Except for the emulsifiers, the following types of ingredients are usually
added to cosmetic emulsions:
Emollients: They improve the sensory properties of the emulsions.
Addition of an emollient results in better spreading when the emulsion
is applied to the skin.
Examples: isopropyl myristate, silicon oils.
Moisturizers and humectants: They increase and control the hydration
state of the skin
Examples: glycerol, urea.
# Viscosity-increasing agents are added to increase the viscosity of the
external phase, if desired. Examples: xanthan gum, cellulose esters.
# Active substances such as Uy sunscreens and vitamins.
# Preservatives to prevent microbial growth, particularly ¡n 01w
emulsions.
# Perfumes and coloring agents for aesthetic purposes
10
11. Oil-in-Water Emulsions
• They feel light and not greasy when applied.
• They show good skin spread ability and penetration and an active
hydration effect by the external water phase.
• They cause a cooling effect because of the evaporation of the external
aqueous phase.
However, 01w emulsions show a lower effect ¡n preventing dry skin in
comparison with w/o emulsions. A typical 01w emulsion is composed as
follows:
1. Lipid(s) lipophilic thickening agent (optional, e.g., microcrystalline
wax) 10—40%
2. Emulsifier system with optimal HLB-value (approx. 9—10 [13]) 5%
3. Co-emulsifier (e.g., cetostearyl alcohol, behenyl alcohol) 2%
4. Preservatives (antimicrobial, antioxidants) q.s.
5. Water hydrophilic thickening agent (optional, e.g., carbomer) ad
100%
11
12. # A good spreading effect is achieved by formation of a low-viscosity
emulsion containing polar oils that show a high spreading coefficient
(e.g., macadamia nut oil, wheat germ oil, isostearyl neopentanoate).
# Selection of the lipophilic ingredients and the excipients of the water
phase determine the emulsifier system to be used and additional
adjuvants, e.g., viscosityincreasing thickening agents. There is no
universal emulsifier system, and a huge variety of combinations might be
used.
# Today, complex emulgator systems that consist of one or more
surfactants and a cosurfactant are commonly used. That means at least
two surfactants with different HLB values are combined. For example,
steareth-21 (HLB 15.5) may be combined with PEG-5- glyceryl stearate
(HLB 8.7). The latter emulsifier is especially suitable when nonpolar oils
are to be incorporated.
# In recent years selected polymeric excipients have been used for
emulsion stabilization, e.g., crosslinked and linear polyacrylates,
polyacrylamides, and derivates of cellulose
12
13. Water-in-Oil Emulsions
Water-in-oil (w/o) emulsions may still be regarded as heavy, greasy,
and sticky although during recent years great progress has been
achieved in the preparation of pleasant w/o emulsions. Therefore, the
w/o emulsion type is not only the basis for water-resistant sun
protection, baby creams, or night creams, but also for protective day
creams.
• Close resemblance to the natural protective lipid layer in the stratum
corneum
• Efficient skin protection attributable to formation of a continuous
layer of lipids on skin after application
• Sustained moisturization because on skin a continuous semiocclusive
barrier is formed that reduces evaporation of skin water and that in
addition actively releases the incorporated water from the internal
phase, generally several times more efficient than 01w emulsions
• Improved penetration into the lipophilic stratum corneum coupled
with improved carrier function of lipophilic active substances, and
even of hydrophilic substances incorporated in the internal aqueous
phase
• Lowered risk of microbial growth
• Liquid at very low temperatures (benefici r sport products)
13
14. A typical w/o emulsion ¡s composed as
follows:
1. Lipid component 20%
2. Lipophilic thickening agent (e.g., wax, optional)
1%
3. Emulsifier system with optimal H LB-value (3—
8) 7—10%
4. Preservatives (antimicrobial, antioxidants) q.s.
5. MgSO4 . 7H20 0.5%
6. Water ( hydrophilic thickening agent, optional)
ad 100%
14
15. • In order to avoid the heavy feel of w/o emulsions,
appropriate excipients must be selected to get products
with well-accepted sensory properties.
• This heavy feel of w/o emulsions is directly related to
the spreading characteristics of the external oil phase.
• Therefore, polar oils with a high spreading coefficient
are preferably used, e.g., macadamia nut oil, isopropyl
isostearate, isostearyl neopentanoate.
• Addition of low-viscosity silicone fluids or volatile
cyclomethicone also improves the spreading effect.
• The physicochemical nature of the lipid components
not only determines the spreading on the skin, the
degree of occiusivity, and skin protection, but also
influences the selection of the emulsifier system
15
16. Multiple Emulsions
• Multiple emulsions are triphasic systems or
emulsions of emulsions. That means there is a
primary emulsion dispersed in an external phase,
e.g., water in-oil-in-water (w/o/w).
• The dispersed phase in the resulting system
contains smaller droplets having the same
composition as the external phase.
• The inner aqueous phase is separated from the
outer aqueous phase by the oil phase, and therefore
the composition of the two aqueous phases may be
different, at least after preparation and for a certain
storage time.
• Preparation and stabilization of multiple emulsions
is a challenging task.
16
17. Gels
• Gels are dispersed systems, originally liquids
(solutions) that have a certain consistency useful and
practical for topical application.
• In contrast to emulsions, gels generally do not
comprise two immiscible phases of opposite
lyophilicity.
• Therefore, the polarity and solubility
characteristics of the incorporated substances are
either hydrophilic—in hydrogels—or lipophilic— in
lipogels (or oleogels).
• The consistency of gels ¡s caused by gelling
(thickening) agents, usually polymers, building a
three-dimensional network.
17
18. Hydrogels
Hydrogels are hydrophilic, consisting mainly (85—
95%) of water or an aqueous-alcoholic mixture and
the gelling agent. The latter is usually an organic
polymeric compound such as polyacrylic acid
(Carbopol), sodium carboxy methylcellulose, or
nonionic celluloseethers.
• Hydrogels have to be preserved against microbial
growth. . After application, hydrogels show a cooling
effect caused by evaporation of the solvent.
• They are easily applicable and humidify
instantaneously, but if applied over a long time they
desiccate the skin. For that reason, humectants such
as glycerol may be added.
18
19. Hydrophobic Gels
• Lip gels or oleo gels are obtained by adding a
suitable thickening agent to an oil or liquid lipid.
For example,
• colloidal silica may be used for that reason.
• A special type of hydrophobic gels is silicone
based systems.
19
20. Micro emulsions
• Micro emulsions contain oil droplets in a water
phase or water droplets in oil with diameters of
about 10 to 200 nm.
• Therefore they appear as isotropic, optically clear
liquid or gel-like systems.
• Unlike miceUar solubilized systems, micro
emulsions may not be thermodynamically stable;
nevertheless, they are more stable than ordinary
emulsions.
• Micro emulsions may be used to incorporate or
dissolve active substances and have been found to
improve skin penetration and permeation.
20
21. Micro emulsions
• Disadvantage of micro emulsions is their
rather high concentration of surfactants, which
is a risk for increased skin irritation and
sensitization.
21
22. Nano emulsions and Nanoparticles
• Special dispersion formulations have been developed and
described that contain ultra small particles used as carriers for
active substances.
• The particles have a size in the range of 10 to a few hundred
nanometers.
• This group of formulations shows a large heterogeneity and
very often various terms or trade names have been created
naming the same or similar systems.
• Generally the par tides are dispersed in an aqueous medium.
• For example, solid lipid nanoparticles possess a solid matrix
composed of physiological lipids or lipoids with a mean
diameter in the range of approximately 50 to 1000 nm
• Active substances may be incorporated into these lipid
nanoparticles serving as carriers, provided that the active
substances are released after application on the skin.
22
23. Solid lipid nanoparticles (SLN)
• The core of nanoparticles may either be a liquid lipid
functioning as carrier or a lipophilic agent being directly
effective, e.g., an emollient or occlusive agent.
• For stabiliza1on, a monolayer of surfactants
surrounding/covering the lipid droplet is used, e.g.,
phospholipids combined with a selected cosurfactant in a
defined ratio.
• Instead of a lipid, lipophilic active substances may be
incorporated, e.g., vitamin A or E, Uy filters, fragrances,
etc.
• This type of nanoparticle is thought to be relatively
insensitive toward the presence of additional surfactants
in contrast to liposomes; therefore they can be mixed with
conventional emulsions and the size of the nanoparticles
remains in the submicron range.
23
25. Suspensions
• Strictly considered, suspensions are not just vehicles but
products consisting of particles, generally actives or
functional excipients, that are dispersed in a liquid or
semisolid medium that functions as a vehicle.
• Nevertheless, a suspension is also a type of formulation
that may be used for application on the skin and to deliver
substances to a target.
• In this way, a suspension can be regarded as a vehicle
entity affecting the application site. Examples are sun-
protection products or pearlescent nail lacquers
containing pigments.
• In suspension, sedimentation of insoluble particles may
happen because of difference in density.
• In order to guarantee a homogeneous product when
applied, the particles must be re-dispersible by shaking
before use. 25
26. Sticks
• A stick is a solid delivery vehicle cast in an
elongated form. By rubbing a stick onto skin, a
variety of cosmetic ingredients can be delivered,
such as fragrances, coloring agents, and
emollients.
• In particular, sticks are ideally suited to deliver
insoluble substances, e.g., pigments.
• The most popular cosmetic sticks are lipsticks
and antiperspirant/deodorant sticks.
26
27. There are mainly three basic vehicle types of sticks:
1. Mixture of waxes (e.g., beeswax, carnauba) and oils
(e.g., mineral, castor oil) that are cast into solid form,
containing dissolved or un-dissolved active ingredients
2. Hydrophilic or aqueous sticks: solutions based on
aqueous, propylene glycol, alcohol mixtures, solidified
usually by sodium stearate, containing, e.g., aluminum
chlorohydrate as antiperspirant
3. Matrix consisting of a high-boiling volatile silicone (e.g.,
cyclomethicone) gelled by fatty alcohol (e.g., stearyl
alcohol)
• In recent years, clear sticks have become popular. As a
gelling agent, dibenzylidene sorbitolis used in propylene
glycol or other related polios.
27
28. FUNCTIONAL DESIGN, COMPOSITION, AND
RESULTING EFFECT
• There is no universal cosmetic vehicle available
that can simply be mixed with an active cosmetic
substance to get the cosmetic care product of
choice, nor is there a general principle that could be
observed to perform development of such a
product.
• But a cosmetic care product has to be developed
and whenever this is the case, various issues and
aspects have to be considered and many problems
must be solved step-by-step.
• Although formulation (galenical development) of
cosmetic products is still rather empirical today, a
rational approach is suggested.
28
29. Target Profile
First, a clear target profile of the product must be defined. This
includes the following:
1. Site of application. Depending on the site, certain forms may not be
adequate, e.g., a w/o cream is not at all suitable for application on hair.
2. Area of application. A sticky, greasy cream cannot be applied on the
whole body surface.
3. Target site. e.g., the uppermost layer of stratum corneum or viable
epidermis.
4. Sensory properties. e.g., foaming shampoo or a light, smooth, low
viscosity cream.
5. Optical aspect. Clear, transparent, or milky, mono- or multiphasic.
6. State of matter. Liquid, semisolid, or solid.
7. Basic type of form. Solution or emulsion.
8. Active substances. Selected vegetable oil, vitamins, Uy screen.
9. Storage stability and conditions.
10. Packaging.
11. Comparable, competitor products.
29
30. Rheology
• The term rheology describes the flow characteristics of
liquids and the deformation of solids.
• Viscosity is an expression of the resistance of a fluid to
flow.
• Rheological properties crucial for liquid and semiliquid
cosmetic formulations because they determine the
product’s properties meaningful in mixing and flow when
produced, filled into containers and removed before use,
as well as sensory properties when applied, such as
consistency, spread ability, and smoothness.
• Furthermore, the rheology of a product may also affect
the physical stability and the biological availability of the
product
30
31. Rheology
Regarding rheological characteristics, there are two main
types of systems:
• Newtonian and non-Newtonian. The former show constant
viscosity when stressed, i.e., the rate of shear (flow velocity) is
directly proportional to the shearing stress, e.g., water, mineral
oil, etc. In non-Newtonian systems (most cosmetic products),
however, viscosity changes with varying stress, i.e., viscosity
depends on the degree of shearing stress, resulting either
• An ideal topical product, e.g., shows optimal thixotropic
properties; it does not flow out of a tube’s orifice unless
slightly pressed, and when on the skin it does not immediately
flow and drop off unless easily spread over the application
area, where under a certain stress it becomes more fluid
because of the thixotropy.
31
32. Rheology
In order to adjust the rheology of products, various
means and excipients are available. If the viscosity
has to be increased, addition of viscosity increasing
agents ¡s needed. Addition or increase in
concentration of electrolytes may influence viscosity.
• Many systems,e.g., polyacrylates, are sensitive to
the presence of ions and the viscosity is reduced.
• In particular, emulsions are susceptible to
rheological issues. Various factors determine the
rheological properties of emulsions, such as viscosity
of internal and external phases, phase volume ratio,
particle size distribution, type and concentration of
emulsifying system, and viscosity-modifying agents.
32
33. Preservation
Antimicrobials
There are various ways to protect a product against microbial
growth:
1. Addition of an antimicrobial agent, which is common
practice
2. Sterile or aseptic production and filling into packaging
material, preventing microbial contamination during storage
and usage
3. Reduced water activity, i.e., controlling growth of spoilage
microorganisms by reducing the available amount of water in
cosmetic preparations.
• It is not only mandatory to add antimicrobials but also to test
their efficacy after manufacturing and after storage until the
expiration date. Nowadays performance of the preservative
efficacy test (PET), also known as the challenge test, is state of
the art
33
34. Antimicrobials
Addition of preservatives to complex, multiphasic
systems, in particular, is a critical formulation issue for
the following reasons:
1. Many preservatives interact with other components of
the vehicle, e.g., with emulsifyers, resulting in change
of viscosity or ¡n phase separation ¡n the worst case.
2. Depending on the physicochemical characteristics,
preservatives are distributed between the different phases
which might result ¡n too-low effective concentration in
the aqueous phase.
3. Adsorption of the preservatives to polymers ¡n the
formulation and/or packaging material; complexation or
micellization might also result in too-low antimicrobial
activity.
34
35. Development Strategy and Rationale
1. Feasibility of preparation or formulation of the active
substance(s) in the vehicle
2. Stability (chemical and physical) of the product, and
3. Effectivity or activity of the product when applied.
• Feasibility
---prepirJt ion of the active suhcranc in dw vehicle
—availability of required equipment and materials
• Activity (effectivity)
• — after application at the target.
• Stability (storage)
—physical
---chemical
35
36. Having in mind those three cornerstones of the formulation
triangle, formulation development to find the right vehicle is
performed stepwise, addressing the following issues:
1. Objective, definition of target profile
2. Preformulation investigation: determination of
physicochemical properties of (active) substances to be
formulated, such as solubility data, partition coefficient,
dissociation constant, pH, crystal morphology, particle size
distribution, and assessment of their stability and
incompatibility
3. Selection of appropriate excipients to be used for
formulation
4. Based on the outcome of these three working steps the
feasibility of preparation is checked and modifications are
made if necessary, all of these together to prepare the next
step
36
37. 5. Formulation screening on a small-scale basis with as many as
possible and feasible variations in composition, excipients,
preparation methods, and so on
6. Selection of the best formulations and preparation methods
from the screening program for technical scaling-up as well as
for confirmation and validation of the results obtained with the
formulations. The selection of the formulations ¡s based on
criteria such as physical stability or absence of precipitation in
solution, no sedimentation or phase separation or
recrystallization in multiphasic systems; chemical stability or
degradation, respectively; preservative efficacy test (PET);
biological assessment, e.g., skin hydration effect, sun protecting
effect, and antioxidant or radical scavenger effect in cells; and
7. Safety evaluation in human beings with foliation chosen for
introduction into market.
37
38. CHARACTERIZATION
Physical Characterization
Appearance
Rheology
• Most disperse systems and thus cosmetic care
products show Non-Newtonian flow behavior,
namely pseudo plastic, plastic, or dilatant behavior.
• A wide variety of techniques and methods have
been developed to measure viscosity properties.
• Methods used for absolute viscosity
measurements are flow through a tube, rotational
methods, or surface viscosity methods. Methods
used for relative viscosity measurement are those
using orifice viscometers, falling balls, or plungers.
38
39. pH
• Measurement of pH value (concentration of
hydrogen ions) ¡n aqueous vehicles (solutions,
suspensions, 01w emulsions, gels) ¡s a valuable
control mean.
• First of all, ¡f possible, a pH value in the
physiological range ¡s generally targeted, ideally
similar to that of the skin or the specific application
site, in order to prevent irritation.
• Many reactions and processes depend on pH, e.g.,
efficacy of antimicrobial preservatives, stability and
degradation of substances, and solubility.
• Thus, pH measurement is a “must” and it is easily
performed with the available measurement systems.
39
40. Homogeneity
Droplet or Particle Size and Distribution
• The physical stability of colloidal systems as well as
emulsions or suspensions partially depends on the
particle size.
• In particular, preparations containing small
particles with identical electrical charge are more
resistant to flocculation and sedimentation than
systems containing larger or uncharged entities.
• Similarly, reduced particle size is an indicator of
improved kinetic stability of emulsions or
suspensions. For that reason, determination of
particle size and size distribution is an important
characterization method.
40
41. Various optical methods are available, a
selection is listed as follows:
1. Perhaps the most commonly used method today
is based on laser diffraction, suitable to measure
solid particles and also dispersed droplets under
special conditions, size range 1 to 600 urn.
2. Dynamic light scattering (DLS), also known as
photon correlation spectroscopy (PCS), is used for
measuring micelles, liposomes, and submicron
suspensions (size range 0.003 to 3 jim).
3. Optical or electron microscopy are further
methods of choice.
41
42. Chemical Characterization
• Besides physical characterization, chemically
based investigations are indispensable to assess the
quality of a product.
• It is well known that the quality and composition
of a vehicle can influence the chemical stability of
ingredients.
• Many reactions, such as ester hydrolysis or other
degradations, may be enhanced or sustained by
change ¡n pH, presence of catalytic or stabilizing
agents , respectively.
• Thus, development and optimal selection of the
best vehicle is supported by chemical stability
investigations.
42
43. Biological Characterization
Further important assessment methods are based 'on
biological tests. This is to evaluate and validate the desired
targeted effects in vivo after application of the product.
Examples Indus dehydration of the skin, protection against
sun radiation, and protection against skin irritating
substances during work.
Sensory Assessment
The sensory assessment is a useful tool for product and
concept development and for quality control in the
cosmetic industry. Although a very subjective and liable
method, valuable data ¡s obtained ¡f sensory assessment is
conducted in a systematic way. Terms like pick up,
consistency, peaking, cushion, absorption, smoothness,
stickiness, tackiness, oiliness, and greasy are used.
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