Cream, Paste & Ointment Dosage Form Design 2 PDF

DOSAGE FORM DESIGN 2 CREAM, PASTE & OINTMENT Dr. Sacha Dubois | Borcelle Pharmacy | 15 January 2023  1.1 Definition and characteristic of cream, paste and ointments 1.2 Usage and types of cream, paste and ointments SUBTOPIC 1.3...

DOSAGE FORM DESIGN 2 CREAM, PASTE & OINTMENT Dr. Sacha Dubois | Borcelle Pharmacy | 15 January 2023  1.1 Definition and characteristic of cream, paste and ointments 1.2 Usage and types of cream, paste and ointments SUBTOPIC 1.3 General compounding for preparation of cream, paste and ointments 1.4 Method of preparation of cream, paste and ointments 1.5 Containers and storage 1.6 Labelling  LEARNING OUTCOME Upon completion of this topic students should be able to : 1. Distinguish cream, ointments and pastes 2.Prepare cream, ointments and pastes 3.Select an appropriate container for packaging of creams, ointments and pastes 4.Prepare an appropriate label for cream, ointments and pastes SEMI SOLID DOSAGE FORM Semisolids constitute a significant proportion of pharmaceutical dosage forms They serve as carriers for drugs that are; topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining Semisolids can adhere to the application surface for sufficiently long periods before they are washed off. This property helps prolong drug delivery at the application site. tamboleh telan 1) consume Semi Solid Dosage Form Semisolid dosage forms are designed for topic application, for treatment wounds, certain mucous membranes or cosmetic function. They have the local therapeutic emollient or protective action, or for the drugs penetration through the skin or mucous membranes. Semisolid dosage forms usually are intended for localized drug delivery However, in the past few years, these forms also have been explored for the systemic delivery of various drug  m It is used externally Probability of side effect can be reduce ADVANTAGES Local action steroid First pass gut and hepatic boleb metabolism is avoided. Define systemic bolen masuh Patient compliance is increased, the drug dim termination is problematic cases is facilitated as blood compared with other routes of drug administration.. ·  No dose accuracy base have tendancy to get easily oxidised DISADVANTAGES bulky to handle application with finger may lead to contamination Physiochemically less stable than solid dosage form  IDEAL PROPERTIES OF SEMI SOLID DOSAGE FORM PHYSICAL PHYSIOLOGICAL smooth texture elegent in appearence Non irritating miscible with skin secretion non dhydrating have low sensitization effect non gritty non greasy & non staining non hygroscopic Easily applicable with efficientdrug release APPLICATION high aqueous washability  DEFINITION AND CHARACTERISTIC - - OF CREAM, PASTE AND OINTMENTS - CREAM OINTMENT PASTE Creams are opaque, viscous, relatively Ointments are homogenous, Pastes are thick, stiff, lut Cahaya soft, consistently spreadable, semisolid translucent, viscous, semi solid semisolid dosage form in dosage form that often comprise more preparation that comprise less than which is high concentration than6 20% water & volatiles and - 20% water & volatiles, and more of insoluble powder normally less than 50% hydrocarbons, - - than 50% hydrocarbons, waxes, or substances (20% to 50%) waxes, or polyols as the vehicle for the - polyols as the vehicle, intended for finely dispersed in a fatty drug substance, intended for external external application. or aqueous base application.. Intsinar , Inteahaya , Samar tembusterns samar.  USAGE AND TYPES OF CREAM, PASTE AND OINTMENTS Intended for topical application majorly as non-invasive delivery system applied for skin, placed on the eye surface, used u intranasally, m sometimes introduced in the body cavities such as vagina or into rectum Dermatitis Eczema infection Ciscoidema) eye infection  CREAM General Uses Of Cream Creams find primary application in topical skin products and also in products used rectally and vaginally. Semisolid preparations containing one or more medicinal agents dissolved in either an o/w or w/o emulsion or in another type of water-washable base. Type Of Ointments G Generally, creams are 2 types: Aqueous um cream (oil-in-water emulsion O/W) Anionic emulsifying wax cream Cationic emulsifying wax cream Non-ionic emulsifying wax cream Oily cream (water-in-oil emulsion W/O) n CREAM  * CREAM a senang natural spread , removala. Properly designed O/W creams are elegant drug delivery system, pleasing in both appearance and feel post application. O/W creams are non greasy and are rinseable. They are good for most topical purpose and are considered particularly Inka suited for application to oozing wounds.. Many patients and physicians prefer creams to ointments because they are easier to spread and remove than ointments. Pharmaceutical manufacturers frequently manufacture topical preparations of a drug in both ointment and cream bases to satisfy the preference of the patient and physician.  CREAM Example of cream  contr paste : -physical sunscreen PASTE - foothpaste. General Uses Of Paste According to USP, Pastes are semisolid preparations of stiff consistency and contain a high percentage (20%–50%) of finely dispersed solids. Pastes are intended for application to the skin, mucous membranes, oral cavity. Generally, pastes do not flow and thus can function as protective coatings and occlusive at normal body temperature. Paste make particularly good protective barrier when placed on the skin, in addition to forming an unbroken film, the solid they contain can absorb and thereby neutralize certain noxious chemicals before they ever reach the skin.  PASTE General Uses Of Paste Pastes are basically ointments into which a high percentage of insoluble solid has been added Paste are less penetrating and less macerating and less heating than ointment. Like ointments, paste forms an unbroken relatively water – impermeable film, an effective sun block. Pastes are less greasy because of the absorption of the fluid hydrocarbon fraction to the particulates.  PASTE Type Of paste There are two types of paste: a) Fatty pastes (eg: - zon paste) and b) Non greasy pastes (eg: - bassorin paste is also named as tragacanth jellies since hydrophilic component of tragacanth gels in water). Pastes are usually prepared by incorporating solids directly into a congealed system by levigation with a portion of the base to form a paste like mass. The remainders of the base are added with continue levigation until the solids are uniformly dispersed in the vehicle.  PASTE examples Of paste :  OINTMENT General Uses Of Ointments 1. Acts as protective or protectant - serve as physical barrier to environment 2. Acts as emollient - softens skin and makes it pliable 3. Carrier of medicament - vehicle Type Of Ointments Either medicated or non medicated & Medicated either dissolved or dispersed in a vehicle as fine powder e.g steroids Non medicated unmedicated ointments are used for physical effects such as protectants or lubricants ⑧  OINTMENT Based on penetration ointment are classified as: Epidermic ointment Endodermic ointment Diadermic ointment Generally, ointment bases recognized for use as vehicles fall into four general classes Hydrocarbon bases, also known as oleaginous ointment bases. Absorption bases Water-removable bases Water-soluble bases, also known as greaseless ointment bases, DESIRABLE PROPERTIES OF OINTMENT BASES OINTMENT  OINTMENT The choice of an ointment base depends on the desired action, the characteristics of the incorporated drug substance, and bioavailability. For example, Hydrocortisone Ointment, Bacitracin Ointment, and Lidocaine Ointment.  Method of preparation of cream, paste and ointments Composition of semi solid dosage form 1. API 2. Bases 3. Preservative 4. Humectants > - nehal moist 5. Anti Oxidants 6. Emulsifier 7. Gelling agent 8. Permeation enhancer 9. Buffer - naval pf > -  PREPARATION OF SEMI SOLIDS (Oinments, Cream & Paste) Chemical reaction Trituration method method EX. Ointments EX. Ointments Creams Creams Pastes g but hot las & Emulsification Fusion method method EX. Ointments EX. Ointments Creams Creams Pastes  Trituration method Mechanical incorporation is performed by TRITURATION in a mortar, or on a glass slab with a spatula. Insoluble powder is first triturated with small amount of levigating agent. um - The levigating agents could be an oil (mineral oil) when preparing oleaginous - - ointment or glycerin and propylene glycol when preparing hydrophilic - - - ointments. - - Used for finely divided insoluble - powder particles or liquids insoluble powder are added by geometric dilution Liquids are added by making well in centre. Air pocket formation avoided. Involved the use of glass slab when small quantities are used, Mortar and pestle used when we have large quantities.  Fusion method Fusion is used for virtually all o/w creams, which are prepared at high temperatures as liquid emulsions and then cooled to the semisolid character at room temperature. 1. Always make excess as transference losses will always occur. se create e 2. Determine the melting points of the fatty bases and then melt together. Starting with the base with the highest melting point, each base should be melted at the lowest possible temperature. 3. Add the ingredients to an evaporating basin over a water bath to avoid- overheating 4. Adding the other ingredients in order of decreasing values, until the softer oleaginous and perhaps liquid ingredients have all been thoroughly incorporated by stirring. 5. The ointment should be stirred gently until it congeals to ensure a homogenous preparation. 6. Powdered medicaments should be incorporated after the base congeals using a small portion of the base as levigating agent. / - 1. Beeswax 63⁰C ---- 2. Hard Paraffin 55⁰C --- 3. Soft Paraffin 43⁰C --- 4. Wool Fat 58⁰C ---- 5. Cetosteryl alcohol 43⁰C --- 6. Spermaceti 46⁰C --- The incorporation of powders into an ointment base o c um - unum · m us um - multile) The incorporation of liquids into an ointment base Preservation of Semisolids Obviously, those semisolids that contain water as a component can support microbial growth with more success than can the hydrophobic semisolids. Sterile preparation would involve microbial filtration of the vehicle, aseptic processing and filling of the container under laminar-flow hoods. Most topical products are not intended to be sterile, but microbial contamination must be controlled. Microbial contamination can cause the development of an odor, a color change, or changes in consistency, with a subsequent change in the drug release rate. Frequently, a chemical antimicrobial preservative is added to inhibit microbial growth. Preservation of Semisolids Examples of topical preservatives include parabens, phenols, benzoic acid, sorbic acid, and quaternary ammonium salts (e.g., benzalkonium chloride). Protection from microbial contamination can be accomplished with proper packaging and storage conditions, which should also protect the product from air, light, moisture, heat and interactions between the product and the container material. Packaging for Semisolids Semisolid products are usually packaged in jars or tubes. Jars -for extemporaneous packaging in a jar, use a flexible spatula and force the product down and along the sides of the jar to avoid entrapping air. On an industrial scale, a specified amount of the semisolid is forced into the jar with a pressure-filler. Tubes are also generally filled using a pressure-fill technique and approaching the tube from the open back end (the end opposite from the cap). Packaging for Semisolids CONTAINER Aluminium tube Ointment Jar Plastic tube Tube with nozzle --Eye oinment STORING AND LABELING STORING ar Keep in cool place, protect from the light. ~ bulan jintain Ointments should be stored in tightly closed and completely filled containers Changes in temperature can lead to the crystallization of the drug and to changes in the ointment base. Ointments and other semisolid preparations are packaged either in large-mouth ointment jars or in metal or plastic tubes. Semisolid preparations must be& stored in well-closed containers to protect against contamination and in a cool place to protect against product separation in heat. When required, light-sensitive preparations are packaged in opaque or light-resistant containers. ↑ STORING AND LABELING LABELING The usual labeling requirements for pharmaceutical products, the USP directs the labeling for certain ointments and creams include the type of base used (e.g.,- water soluble or water insoluble). - For external use only Administration of Topicals 1. Topical dosage forms are expensive and it is important for you as a pharmacist to council the patient to receive the maximum benefit. 2. Before application, cleanse the affected area and the healthy skin surrounding it with soap and water unless otherwise directed by a physician or by directions accompanying the medication. 3. Dry the cleansed area. 4. Topical should be applied as a thin film and spread evenly on the skin. Overuse, in general, is a waste of product. When using a solution, two or three drops should be placed on the area. 5. Gentle massaging after application of a topical may be advised to cover the affected area. 6. Wash the medication off your hands with soap and water. 7. Occlusion of the affected area with a bandage or gauze is usually not required and the medicated area should be left uncovered. z Thank DO SOMETHING you!! TODAY THAT YOUR FUTURE SELF WILL THANK YOU FOR. Our actions and decisions today will shape the way we will be living in the future.