Welcome to My Presentation On Ointment Course Title : Pharmaceutical Chemistry sessional and Field Visit Presented By : Sagar Kumar dutta Student I.D- 111815
About KEMIKO Pharmaceutical Company Kemiko, one of the fastest growing Pharmaceuticals company, has been going through manufacturing and marketing of Pharmaceuticals, herbal, Food supplement and veterinary products. Since its inception in 1988, the company has always been committed to serve the mankind with the best products and services. They have got highly qualified and experience professionals in all departments including Research and Development , Production, Quality Assurance, Quality Control. The plant of this company is equipped with modern facilities, including clean zones for production and HPLC, atomic Absorption Spectrophotometer etc. for Q.A. The company, with all these facilities, strictly follows the WHO-guided Good manufacturing Practices (GMP)
Objectives of the Tour To gather practical knowledge of Pharmaceutical product production. To see the raw materials they used in pharmaceutical product production. To acquire practical knowledge about the technical information in Pharmaceutical product production. To acquire knowledge about testing process of making good quality Pharmaceutical product. To know about the mechanical process of Pharmaceutical product production.
What is drug? Drug is any article whether natural or synthetic having therapeutic and medicinal properties and used in the diagnosis, cure, mitigation, treatment or prevention of disease in man and other animals. What is medicine? Medicine is the dosage form of the drug. Drug is the active ingredient of the medicine. Medicine= Drug + excipient Gels Solutions Ointments Oils Creams Foams Sprays
Solid medicine. Semi solid medicine. Liquid medicine . Semi Solids: Semi solids are different types like cream, ointment, jelly etc. Kemiko Pharmaceutical generally produce two types of semi-solid. They are 1. Cream- Oil & Water mixture Two types i) Water in oil e.g. cold cream & ii) Oil in water e.g. vanishing cream 2. Ointment – Only Oil Types of medicine (According to the doses form)
Ointment Ointments are soft semisolid preparation meant for external application to the skin or mucous membrane . They usually contain medicament, which is either dissolved or suspended in the base . What is Ointments? Medicinal application of the Ointment Ointment bases Preparation of the Ointments Storage and dispensing Ointments Characteristics of an Ideal Ointment It should be chemically and physically stable. It should be smooth and free from grittyness. It should melt or soften at body temperature and easily applied. The base should be non-irritating and should have no therapeutic action. The medicament should be finely divided and uniformly distributed throughout the base. Classification of Ointment
Classification of Ointment Antibiotic Ointment: Used to kill the micro-organisms 2. Anti-fungal Ointment: Used to kill the fungi. 3. Anti-inflammatory Ointment: To relieve inflammatory 4. Antipruritic Ointment: To relieve itching. 5. Protectant Ointment: Protect the skin from moisture , air sun ray etc. And there are also several types Ointment are found. Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Preparation of the Ointments Storage and dispensing
Medicinal application of the Ointment Ointments are used topically for several purposes, e.g., as protectants, antiseptics, emollients , antipruritic, kerotolytics, and astringents. In the case of a protective ointment, it serves to protect the skin against moisture, air, sun rays and other external factors. It is necessary that the ointment neither penetrates the human skin barriers nor facilitates the absorption of substances through this Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Preparation of the Ointments Preparation of the Ointments Storage and dispensing
An antiseptic ointment is used to destroy or inhibit the growth of bacteria. Frequently bacterial infections are deeply seated; a base which has the capacity to either penetrate or dissolve and release the medication effectively is therefore desired. Ointments used for their emollient effect should be easy to apply, be non-greasy and effectively penetrate the skin Different types of chemical are used for preparing the ointment such as: Salicylic acid , titanium dioxide , petrolatum, zinc oxide coal etc. Medicinal application of the Ointment Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Preparation of the Ointments Storage and dispensing
Ointment base Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Preparation of the Ointments Storage and dispensing
Ointment base Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Oleaginous O.B. Absorption O.B. W/O emulsion O.B. O/W emulsion O.B. Choice of the O.B. Water miscible O.B. Preparation of the Ointments These bases are fats, fixed oils, hydrocarbon or silicones. They are anhydrous, greasy, non-washable does not absorb water and occlusive (form a film on skin so it increases the skin hydration by reducing the rate of loss of surface water. They should not be applied to inffected skin. they are used as protectants, emollients , vehicles for hydrolyzable drugs. Example: White Petrolatum, White Ointment Storage and dispensing
Ointment base Oleaginous base + w/o surfactant. Anhydrous but hydrophilic ointment bases, they can absorb several times their weight of water to form water-in-oil emulsion. They are non-washable, not water soluble They used as protectants, emollients (+/-), vehicles for aqueous solutions, solids, and non- hydrolyzable drugs. Example: Hydrophilic Petrolatum, Anhydrous Lanolin, Aquabas , Aquaphor , Polysorb Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Ointment bases Oleaginous O.B. Absorption O.B. W/O emulsion O.B. O/W emulsion O.B. Choice of the O.B. Water miscible O.B. Preparation of the Ointments Storage and dispensing
Ointment base These are anhydrous, hydrophilic, absorbs water and non water removable, with low thermal conductivity and occlusive. They have the same properties as the absorption basees . They are used as emollients, cleansing creams, vehicles for solid, liquid, or non- hydrolyzable drugs . Examples: Cold Cream type, Hydrous Lanolin, Rose Water Ointment, Hydrocream , Eucerin , Nivea . Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Oleaginous O.B. Absorption O.B. W/O emulsion O.B . O/W emulsion O.B. Water miscible O.B. Choice of the O.B. Ideal O.B. Preparation of the Ointments Storage and dispensing
Ointment base These bases are anhydrous, water soluble, absorb water and water washable. They are either carbowaxes Polyethylene Glycols (PEGs) or hydrated gums ( bentonite , gelatin, cellulose derivatives). They are used as drug vehicles. Examples : PEG Ointment, Polybase ™ Water miscible O.B. These bases are anhydrous, water soluble, absorb water and water washable. They are either carbowaxes Polyethylene Glycols (PEGs) or hydrated gums ( bentonite , gelatin, cellulose derivatives). They are used as drug vehicles. Examples: PEG Ointment, Polybase ™ Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Oleaginous O.B. Absorption O.B. W/O emulsion O.B. Water miscible O.B. Preparation of the Ointments Storage and dispensing O/W emulsion O.B .
PRESERVATIVES Some bases , although, resist microbial attack but because of their high water content, it require an anti microbial preservative. Commonly used preservative include: Methyl hydroxy benzoate Propyl hydroxy benzoate Chorocresol Benzoic acid Phenyl mercuric nitrate Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Preparation of the Ointments Storage and dispensing Preservatives Choice of the O.B. Factors
Selection of the Appropriate Base Based on: Desired release rate. Desirability for enhancement of percutaneous absorption. Advisability of occlusion. Short-term or long-term stability. Influence of drug on consistency or other features of ointment base. Patient factor - dry or weeping (oozing) skin. Factors Governing Selection of an Ideal Ointment Base 1. Dermatological factors . a ) Absorption and penetration Only the ointment base penetrates deep into the tissues of the skin. Substance which are soluble both in oil and water are most readily absorbed. Water soluble substances are more readily absorbed from water soluble bases. b) Effect on skin Function: Greasy bases interfere with normal skin functions. O/W emulsion bases and other water miscible produce a cooling effect rather than heating effect and mix readily with skin secretions. c) Miscibility with skin secretions and serum . d)Compatibility with skin secretion e) Ease of application and removal . This point are dermatological factors for selection of an ideal ointment base. Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Preservatives Factors Preparation of the Ointments Storage and dispensing Choice of the O.B.
Factors Governing Selection of an Ideal Ointment Base 2 . Pharmaceutical Factors : Stability Fats and oils obtained from animal and vegetable sources are liable to undergo oxidation unless they are suitably preserved. Emulsions prepared with wool fat are liable to surface discoloration b) Solvent properties Most of the ointment base are finely powdered and distributed uniformly throughout the base A base consisting of a mixture of hard paraffin, soft paraffin's bees wax is used . c) Emulsifying Properties d) Consistency This point are dermatological factors for selection of an ideal ointment base. Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Preservatives Choice of the O.B. Factors Preparation of the Ointments Storage and dispensing
Preparation of the Ointment Water phase prepare in container (A) at temperature of 70 C Flow diagram of general preparation of ointments Oil phase prepare in container (B) at temperature of 70 C vacuum vacuum Min vessel (mixing), stirring at 800 C for 50 min ( high speed =1500rpm and low=45 rpm) Milky appearance Congealing for 1 hr Ointments What is Ointments? Classification of Ointment Medicinal application of the Ointment Preservatives Choice of the O.B. Factors Preparation of the Ointments Storage and dispensing
Preparation of the Ointment Transferring and weighing yield QA Approval Filling and packing Two mixing techniques are frequently used in making ointment Fusion, in which ingredients are melted together and stirred to ensure homogeneity . Trituration , in which finely-subdivided insoluble medicaments are evenly distributed by grinding with a small amount of the base or one of its ingredients followed by dilution with gradually increasing amounts of the base fusion Trituration Ointments What is Ointments? Medicinal application of the Ointment Classification of Ointment Choice of the O.B. Preservatives Factors Preparation of the Ointments Storage and dispensing 1. Fusion , 2. Trituration
Packing, labeling and Storage Packing: The ointment are generally packed in ointment jars or collapsible tubes. Amber coloured glass jar are used for light-sensitive preparations. While filling the ointment jar ointment jar care must be taken to avoid the entrainment of air. Collapsible tubes made up of tin are also used for filling the ointments. Storage: The ointment should be stored in well closed containers and in a cool place. High temperatures are likely to soften or melt the base during storage there rendering the preparation unfit for use. Labeling: Ointment jar should be labeled with good quality of self-adhesive labels. Self –adhesive strip labels are used because the ordinary gummed labels do not stick well to the surface of the container.
Stability of Ointment The ointment should remain stable from the time of preparation to the time when whole of it is consumed. On long storage the ointments lead to microbial growth therefore a suitable preservative must be added to inhibit the growth. Ingredients like wool fat and its derivatives lead to oxidation.so antioxidant may be added to protect the active ingredients from oxidation. Humectants such as glycerin, propylene glycol and sorbitol may be added to prevent the loss of moisture from preparation. Ointment must be stored at an optimum temperature otherwise separation of phase may take place. Ointments
Advantages and Disadvantages: Advantages Handling of ointments is easier than bulky liquid dosage forms. They are chemically more stable than liquid dosage forms. They facilitate application of the directly to the effected body part and avoid exposure of other parts to the drug. They prolong the contact time between the drug and effected area . The bioavailability of drugs administered as ointments is more since it prevents passage through liver. Disadvantages: They are bulkier than solid dosage forms. When applications of an exact quantity of ointment to the affected area is required, it is difficult to ascertain the same . They are less stable than solid dosage form Ointments