DDDS LAB .pdf

SOLID DOSAGE FORMS -transparent waterproof paper. ‣ WHITE BOND PAPER- non-moisture resistant properties SOLID DOSAGE FORMS ADV...

SOLID DOSAGE FORMS -transparent waterproof paper. ‣ WHITE BOND PAPER- non-moisture resistant properties SOLID DOSAGE FORMS ADVANTAGES AND DISADVASNTAGES OF BULK, 1. POWDER -A dry or solid pharmaceutical BLENDED, OR DIVIDED POWDERS preparation composed of finely divided particles DISADVANTAGES intended for internal or external use. ‣dispensing is limited to non-potent substances >Topical Powder- for external use only >Oral Powder - for internal use -Spilled easily >Insufflated Powders- applied in body cavities ADVANTAGES 2. GRANULES - Compose of dry aggregates or dry -can be mixed with water or beverages before powder particles that may contain one or more swallowing APl's, with or without other ingredients. -The dose can be easily altered/adjusted 3. CAPSULES -are solid dosage forms in which -It can be easily swallowed by infants and young medicinal agents and/ or inert substances are children enclosed in a small shell of gelatin. -Suitable dosage form for bulky drugs -Provide a rapid onset of action 4.TABLETS-are solid dosage forms usually -Readily dispersed prepared with the aid of suitable pharmaceutical -Large surface area excipients by compression or molding. -Require only dissolution PREPARATION 1: DIVIDED POWDERS DIFFERENT METHODS OF DETERMINING PARTICLES POWDERS- are mixtures of dry and finely divided SIZE: solids or chemicals that may be used internally or -sieving externally. -Microscopy INTERNAL USE: -sedimentation rate -Oral -light energy diffraction or light scattering -Laser -Intranasal holography -Insufflation -Cascade impaction EXTERNAL USE: Cosmetics MIXING TECHNIQUES: OTHER USES: Solutions Douches -Random mixing 2 TYPES OF POWDER - Ordered mixing bulk powders EX 1: SODIUM BICARBONATE AND CALCIUM divided powders LARGE SCALE COMMINUTION TECHNIQUES: CARBONATE (BULK POWDERS) various mills SYNONYM: Sippy powder no.1 Pulverizers USES: Antacid, Antipruritic SMALL SCALE COMMINUTION TECHNIQUES: 1. Usual Dose: 300mg- 16g a day; 300mg to 2g - Trituration 4xa day pulverization by intervention 2. How to administer? levigation Mix powder with water or other beverages before MICROMETRICS-study of small particles. swallowing SUITABLE CONTAINERS: 3. Best Container: Bulk containers, a perforated or metal foil sifter can, aerosol container or wide mouth glass or small heat-sealed or resealable plastic bags pasteboard jar. other containers EX.2: SEIDLITZ POWDER (NF) DIVIDED -The method of preparation is block and divide. POWDER TYPES OF PAPER USED FOR DIVIDED POWDERS: SYNONYM: Compound effervescent powder ‣ VEGETABLE PARCHMENT USES: Saline cathartic -thin semi-opaque paper with limited moisture 1.Potassium sodium tartrate-API resistance. 2. It can be administered orally. It is mixed with ‣ GLASSINE - a glazed transparent paper, also water or other suitable material prior to with limited moisture resistance. administration or applied locally. They may also be ‣ WAXED PAPER GAVIETA,ZA.1 | P a g e prepared as dentifrices, products for reconstitution, VERY FINE No.80 All particles insufflations, aerosols. pass through 3. Divided powder can be divided through block & a No. 80 divide method sieve. There is no limit to PREPARATION 2: EFFERVESCENT GRANULES greater GRANULES-Compose of dry aggregates or dry fineness powder particles that may contain one or more ADVANTAGE OF GRANULES OVER POWDERS: APl's, with or without other ingredients. -Granules flow well compared to powders They are irregularly shaped but may be spherical. COMPOSITION OF EFFERVESCENT GRANULATED- Granules are handled using a sieve with a size SALTS AND THEIR PURPOSES range of 4-12. - Sodium bicarbonate Effervescent granulated salts are granules or -Citric acid coarse to very coarse powders that contain a -Tartaric acid medicinal agent in a dry mixture. -When added to water, the acids and the base It is composed of sodium bicarbonate, citric acid, react to liberate carbon dioxide, resulting in and tartaric acid. effervescence. The resulting carbonated solution METHODS OF PREPARATION USED: masks undesirable taste of any medicinal agent. dry or fusion method COMMERCIALLY AVAILABLE GRANULES AND THEIR wet method INDICATION: USP #STANDARD FOR POWDERS OF ANIMALS -Acetylcysteine (Fluimucil)200mg and 100 mg - AND VEGETABLES DRUGS\POWDERS mucolytic CHEMICAL Hydrite-Oral Rehydration salts EUTEXIA VERY COARSE No.8 All particles > A Phenomenon wherein substances such us pass through acetanilide, acetophenetidin, aminopyrine, a No. 8 sieve. antipyrine, aspirin, benzocaine, beta-naphthol, and not more camphor, chloral hydrate, lidocaine, menthol than 20% phenacetin phenol, phenyl salicylate prilocaine, pass through a No. 60 resorcinol salicylic acid thymol soften or liquify sieve. when mixed at ordinary temperature. COARSE No. 20 All particles HOW TO AVOID EUTEXIA? pass through >Eutectic compounds should be mixed first with a a No. 20 portion of the diluent and gently blended, sieve and not preferably with a spatula on a sheet of paper. more than > An amount of diluent equal to the eutectic 40% pass compound is sufficient to prevent liquefaction for through a No. about 2 weeks. 60 sieve. > Deliberate forcing of the formation of the liquid MODERATELY No.40 All particles state, by direct trituration, followed by absorption of COARSE pass through moist mass will overcome this problem. a No. 40 sieve, and not PREPARATION 3: PARACETAMOL TABLET more than TABLETS - are solid dosage forms usually 40% pass prepared with the aid of suitable through a No pharmaceutical excipients by compression or 80 sieve. molding. FINE No.60 All particles pass through Tablet excipients include diluents, binders or a No. 60 adhesives. disintegrants, lubricants, anti- sieve, and not adherents, glidants, colors or dyes, flavoring more than agents, and artificial sweeteners. 40% pass through a No. Tablets are classified according to their route 100 sieve. of administration, drug delivery system, and form or method of manufacture. GAVIETA,ZA.2 | P a g e  DILUENTS-add the necessary bulk to a formulation -Elegant and free from defects such chips, cracks, to prepare tablets of the desired size discoloration and contamination. BINDERS AND ADHESIVES-promote adhesion of the -An ideal tablet should withstand mechanical particles of the formulation shock during its production, packaging shipping DISINTEGRANTS-promote breakup of the tablets and dispensing. after administration to smaller particles for ready -It should have chemical and physical stability to drug availability maintain its physical attributes over time. LUBRICANTS, ANTI-ADHERENTS, GLIDANTS -enhance PREPARATION # 4: CHOCOLATE BASED the flow of the material into the tablet dies minimize CALCIUM LOZENGES wear of the punches and dies, prevent fill material Designed to dissolve or disintegrate in the mouth. from sticking to the punches and dies, and produce There are three types of lozenges: tablets with a sheen 1. HARD LOZENGES-made from syrups of sucrose Colors/dyes- appearance and other sugars and/or carbohydrates that are Flavoring agents-mask the unpalatable taste boiled so that the moisture content in the product is Artificial Sweeteners- palatability 0.5% to 1.5%. CLASSIFICATION OF TABLETS BASED ON THE 2. SOFT LOZENGES- made from a flavored fatty METHODS OF FORM OF MANUFACTURE base (chocolate, a polyethylene glycol (PEG) base, - multiple compressed tablets, Coated tablet, or a sugar-acacia base) Buccal & sublingual, chewable, effervescent, 3. CHEWABLE GUMMY GEL LOZENGES- made of a molded, tablet triturates, immediate release tablets, glycerinated gelatin base that are chewable oral extended release, vaginal tablets. drug preparations. COMMON PROCESSING PROBLEM IN THE HAND ROLLING MANUFACTURE OF TABLETS - is a method used for preparing lozenges that do -lamination not require special calculations and equipment -Capping except for a pill roller, a broad- bladed spatula, or any flat nonreactive material that can be used for DIFFERENTIATE THE WAYS OF IMPRINTING LOGOS ON this purpose. TABLETS FUSION -also known as molding is a method used -debossed, embossed, engrave for making hard candy, chocolate, and gummy gel ADVANTAGES chewable lozenges. This method requires heat, a -Easy to swallow special mold, skills, and calculations to obtain a -Easy to dispensed satisfactory preparation. The dosage unit may be -More stable dosage form determined either by weight or volume or both. -Maintain accuracy of dosage Caution must be exercised when adding heat- -Easiest and cheapest to pack and transport sensitive drugs. DISAVANTAGES Difficult for pediatrics to swallow -Some drugs resist compression into dense compact, owing to amorphous nature, low density character -Cannot be used on emergency cases, because it reaches the active site slowly. -Bioavailability of some drugs may be low due to poor absorption from the gastric tract. Ideal Characteristics of Tablets -Elegant and free from defects such as chips, cracks, discoloration and contamination. OTHER USES OF LOZENGES: -An ideal tablet should withstand mechanical They are used for both local and systemic action. shock during its production, packaging, shipping Typically, the active drugs include antiseptics, and dispensing. analgesics, decongestants, antitussives, and -It should have chemical and physical stability to antibiotics. Some molded lozenges may also be maintain its physical attributes over time. called cough drops or pastilles. Lozenges can be IDEAL CHARACTERISTICS OF THE TABLETS made by compression or molding. GAVIETA,ZA.3 | P a g e PEPPERMINT TROCHES PREPARATION 5: ASPIRIN CAPSULE SYNONYMS: Eucalyptus/ menthol ACETAMINOPHEN (325mg) CAPSULE USES: Carminative SYNONYM: Paracetamol 1. WHAT ARE TROCHES? USES: Antipyretic, Analgesic These are discoid-shaped solids containing the 1. USES OF EACH INGREDIENT: medicinal agent in a suitable flavored base. >Acetaminophen- Active pharmaceutical ingredient PASTILLES AND LOZENGES -differ in method of prep. >Sodium starch gluconate - Disintegrant 2. HOW TO ADMINISTER? >Magnesium stearate/stearic acid-lubricant/glidant Troches are placed in the mouth where they slowly dissolve, liberating the active ingredient. CAPSULES-are solid dosage forms in which medicinal agents and/ or inert substances are enclosed in a small shell of gelatin. PREPARATION #5: ASPIRIN CAPSULE PUNCH METHOD When filling a small number of capsules in the pharmacy, the pharmacist may use the punch method. The pharmacist takes the precise number of empty capsules to be filled from the stock container. By counting the capsules as the initial step rather than taking a capsule from stock as each one is filled, the pharmacist guards against filling the wrong number of capsules and avoids contaminating the stock container with drug powder. The powder to be encapsulated is placed on a sheet of clean paper or on a glass or porcelain plate. Using the spatula, the powder mix is formed into a cake having a depth of approximately one-fourth 4. Capsules should be sealed to avoid tampering to one-third the length of the capsule body. incidents. Then an empty capsule body is held between the 5. Capsules should be cleaned and polished to thumb and forefinger and punched vertically into avoid small amounts of powder to adhere to the the powder cake repeatedly until filled. outside of the capsules which may give a bitter or unpalatable taste. 6. Excipients added: diluent/filler, disintegrant, lubricant/ glidant, colorant, surface active agent, wetting agent, capsule opaquant. TERMS AND DEFINITION Antacid -drug that neutralizes excess gastric acid. Antipruritic- drug that reduces itching: Cathartic-drug that promotes defecation, usually considered stronger in action than a laxative. Analgesic-drug that suppresses pain perception without inducing unconsciousness. Antipyretic - drug that restores normal body temperature in the presence of fever. Carminative -drug that relieves flatulence. Diluent - used as disintegrants in the dispersible and orally disintegrating tablets. Fillers - used to make up the volume of tablets. GAVIETA,ZA.4 | P a g e Disintegrant - breaks down solid dosage forms -a pharmacist may mix the components using a into small particles so that the drugs can be readily mortar and pestle, or a spatula may be used to rub available to dissolve in gastrointestinal fluid the ingredients together on an ointment slab (a Glidant - substance that enhances the flow of a large glass or porcelain plate or pill tile). granular mixture by reducing interparticle friction. B. FUSION Lubricant - reduces friction. -all or some of the components of an ointment are Surface active agent - excipients that lowers combined by being melted together and cooled surface tension or interfacial tension. with constant stirring until congealed. Components Wetting agent surface-active molecule use to not melted are added to the congealing mixture as reduce surface tension. it is being cooled and stirred Colorant - coloring additives or coloring agents C.TRITURATION Occlusive - dressing that closes a wound and - is a technique wherein you grind a substance to keeps it from air. form a fine powder. Emollient effects -soothe and hydrate the skin, - D.LEVIGATION moisturizing treatments - A technique of reducing substances to tum Emulsifier - substance that stabilizes an emulsion. smooth paste. prevents breakdown of an emulsion. E.GEOMETRIC DILUTION SEMI SOLID DOSAGE FORMS - Method of combining fine powders portion by OINTMENTS portion, to ensure equal distribution. -Semisolid preparations intended for external HYDROPHILIC OINTMENT application to the skin or mucous membranes. SYNONYMS: Unguentum hydrophilicum, Pomada OINTMENT BASES- used as vehicles for hidrofila medicated ointments. USES: Used as a water removable ointment >oleaginous bases / hydrocarbon bases (washable ointment) protectant >Absorption bases 1. FUSIBLE BODIES PRESENT: Wax, spermaceti >Water-removable bases 2. OINTMENT BASE USED: Water removable bases >Water-soluble bases or 0/W emulsion ointment bases OLEAGINOUS BASES HYDROCARBON BASE 3. INGREDIENTS: Methylparaben and PETROLATUM, USP- a purified mixture or semi solid Propylparaben -Anti-microbial agent hydrocarbons obtained from petroleum. (Methylparaben: anti-yeast: Propylparaben: anti- WHITE PETROLATUM, USP - a purified mixture of molds) semisolid hydrocarbons from petroleum that has Sodium LauryI Sulfate - Emulsifier or Surfactant been wholly or nearly decolorized. Propylene Glycol - Humectant WHITE OINTMENT, USP- ointment differs from yellow Stearyl Alcohol- Stiffening agent; can cause ointment by substitution of. white wax (bleached crystallization when large amounts are added and purified yellow wax) and white petrolatum in (instability) White Petrolatum Hydrocarbon base the formula. 4.HYRDOPHILIC PREPARATION- Are non occlusive, ABSORPTION BASES can be diluted with water, water washable, non- E.g. Hydrophilic Petrolatum, USP Lanolin, USP greasy. (Anhydrous lanolin) 5. ABSORPTION BASE A.K.A ABSORBENT BASE WATER REMOVABLE BASES a.Those consisting of bases that permit the - are oil-in-water emulsions resembling creams incorporation of aqueous solution with the Because the external phase of the emulsion is formation of a water-in-oil emulsion/ anhydrous/ aqueous, they are easily washed from skin and emulsifiable bases are often called water-washable bases. b. Those consist of W/0 emulsion that permit the - E.g. Hydrophilic Ointment, USP incorporation of additional quantities of aqueous WATER SOLUBLE BASES solution or W/0 type. - do not contain oleaginous components. They are WHITE OINTMENT, USP completely water washable and often referred to SYNONYMS: Simple Ointment; 0intment USP XI; as greaseless. Unguentum Album; Simple Ointment E.g. Polyethylene Glycol Ointment, NF USES: Emollient; Vehicle for other ointments A.INCORPORATION 1. COMPONENTS: Wax, White Petrolatum GAVIETA,ZA.5 | P a g e  2. OFFICIAL DEFINITION: White ointment is an wax (bleached and purified yellow wax) and the ointment consisting of 5% white wax and 95% of white petrolatum in the formula. white petrolatum CREAMS PREPARATION #8: WHITE OINTMENT - Creams are semisolid preparations containing HOW ARE OINTMENT JARS FILLED ON SMALL- one or more medicinal agents dissolved or SCALE OINTMENT PREPARATION WITH THE USE dispersed in either a W/0 emulsion or an oil-in- OF SPATULA: water emulsion or in another type of -water- The ointment jars on a small-scale ointment washable base. preparation can be filled with the use of -Creams find primary application in topical skin Mechanical Incorporation via the spatulation with products and in products used rectally and geometric dilution technique vaginally. The powder is placed with an approximately PASTES equal volume of the diluent in a mortar and is -Pastes are semisolid preparations intended for mixed thoroughly by trituration. application to the skin. They generally contain a Then, the previously powdered components are larger proportion of solid material (such as 25%) mixed together with the portion of the base and than ointments and therefore are stiffer. the trituration repeated. This process is continued -Because of the stiffness of pastes, they remain in until all of the diluent is incorporated place after application and are effectively STEPS ON FILLING AN OINTMENT JAR BY employed to absorb serous secretions. It is not UTILIZING A SPATULA: suited for application in hairy parts. 1. Fill the bottom of the ointment jar COLD CREAMS 2. Use the spatula to put ointment into the SYNONYM: Unguentum Aquae Rosae Petrolatum, crevices Petrolatum Rose water ointment 3 Continue adding the preparation to the jar using USES: Emollient, cleansing cream and ointment the spatula to put it along the sides of the jar. Base 4 As you fill the jar, stab the spatula into the 1. TYPE OF OINTMENT BASE: W/O emulsion ointment preparation a couple of times. This will reveal air base pockets that may have formed 2.Diff.Cold cream from Rose water ointment: They 5. Put the spatula halfway across the filled jar, differ only in that mineral oil is used in place of and tilt in slightly, almond oil and omitting the fragrance 6. Rotate the jar and this makes a professional- 3. If the ointment was chilled it should be Warmed looking finish on the top of the ointment 4. Precaution: Free from rancidity 7. Wipe off the preparation from the threads of the 5. Problems with ointments: rancidity, blending, jar and cap it to avoid possible contamination. change in consistency due to aging or changes PREPARATION #8: WHITE OINTMENT with temp. WHAT IS THE DIFFERENCE BETWEEN WHITE INGREDIENTS: OINTMENT USP AND YELLOW OINTMENT USP Cetyl ester wax -Texturing agent The Yellow ointment, USP is prepared by melting White wax- Stiffening agent Mineral oil- the yellow wax on a water bath, adding the emollient/texturing agent petrolatum until the mixture is uniform, then cooling Sodium borate - preservative/alkalizing agent and stirring until congealed. Also called simple Purified water -vehicle ointment, it has a slightly greater viscosity than 1. Method of preparation used in cold cream, plain petrolatum The yellow ointment that was was it an official or non-official prep according to utilized is the purified wax which is obtained from the honeycomb of the bee Apis mellifera. the USP/NF? The formula for the Yellow Ointment, USP are listed Method of preparation is the fusion method, and the preparation used is official under the USP/NF. below: YELLOW WAX.............. 50 g 1. Why is cetyl alcohol used in the preparation? Spermaceti wax is used as a thickening agent and PETROLATUM.....950 g emulsifier in the preparation of cold cream. When On the other hand, is the White ointment USP. the spermaceti wax undergoes a boiling process, The only difference between the yellow ointment cetyl alcohol can be formed. With this in hand, and White ointment can be found in the formula. spermaceti wax can be substituted for cetyl alcohol The yellow wax will be substituted by the white GAVIETA,ZA.6 | P a g e in the formulation since they have the same insert your finger inside to extract a part of its possess the same component. contents. ZINC OXIDE PASTE WITH SALICYLIC ACID SULFUR OINTMENT SYNONYM: Lassar's paste Pasta zinc oxidi coun SYNONYM: Sulfur Ointment; Unguentum de Azufre; acido salycilico Unguentum Sulfuris;. Lae Sulfuris Ointment USES: mild astringent, protective, antibacterial and USES: Parasiticide, Keratolytic, used in the antifungal properties with salicylic acid treatment of skin diseases such as psoriasis and 2%- salicylic 98% zinc oxide paste seborrhea, Used as an alternative treatment for OFFICIAL DEFINITION: Zinc Oxide Paste contains Scabies not less than 24.0 percent and not more than 26.0 1.COMPONENTS: Precipitated sulfur, Mineral 0il, percent of ZnO White Ointment, USP Sulfur ointment contains NLT 2. IDENTIFICATION TEST: The residue obtained in 9.5% and NMT 10.5% of sulfur (S). the Assay for Z0 is yellow when hot and white 2. INGREDIENTS: Precipitated Sulfur - Active when cool. ingredient:(Anti-fungal, Antibacterial) Mineral 0il- 3.DIFFERENCES: Levigating agent: (aids the incorporation of Zinc oxide paste-Zn0, starch and white petrolatum ointment) White 0intment - Oleaginous or Zn0 ointment-Zn0, mineral oil and white ointment Hydrocarbon base Lassar's Paste-Zn0 paste with salicylic acid 3. PACKAGING& STORAGE: Preserved in well-closed INGREDIENTS: containers, and avoids prolonged exposure to Zinc Oxide- Active ingredient (provides a protective excessive heat. barrier; astringent; antiseptic) Method of preparation use, was it an official or non- Starch-Binding Ingredient (makes paste firm) official preparation according to the USP/NF: White Petrolatum - Ointment base: Method of preparation? (oleaginous/hydrocarbon bases) -The method of preparation used is Mechanical Zinc Oxide Paste - (Lassar's Plain Zinc Paste) - Incorporation. prepared by levigating and mixing 25% each of Official or non-official preparation? Zinc oxide and starch with white petrolatum. - According to the USP 41- NF 36, the Sulfur 1.Method of preparation use, was it an official or non- Ointment is an official preparation official preparation according to the USP/NF: Stepwise procedure on filling ointment tubes with -The method of preparation used in the prepared ointments using small-scale filing machine: preparation of zinc oxide ointment is the I. The prepared ointment, placed on waxed or Incorporation method and the preparation is official parchment paper and rolled into a cylindrical according to the USP shape, is inserted into the open end tube and 1. What is the maxim on the use of an iron steel pushed forward as far as allowed. spatula when preparing ointments? IL. With spatula pressing against the lower portion -Metal spatulas such as iron or steel spatulas of the tube and making a crease below the should not be used in making iodine, mercurial, or ointment fill, the paper is slowly removed. leaving tannic acid ointments. the ointment in the tube. 3. Why are collapsible tubes more preferred than IlI.The bottom of the tube is flattened, folded, and sealed with a crimping tool or clip ointment jars as containers for ointments? - Collapsible tubes are lighter and more space- RANCID - having an unpleasant smell or taste efficient which makes them easier to carry and usually from chemical change or decomposition. store compared to ointment jars. Collapsible tubes ASTRINGENT-a drug used topically to toughen and are more convenient to use since their ointment shrink tissues. contents can be easily accessed just by squeezing ANTIFUNGAL- a drug that kills or inhibits pathogenic the tubes. Furthermore, collapsible tubes help fungi. minimize contamination of the ointment because of ANTIBACTERIAL -a drug that kills or inhibits their smaller openings that restrict the entry of pathogenic bacteria. dust, moisture, and other foreign particles. In PROTECTIVE/PROTECTANT - topical drug that ointment jars, the ointment has a high risk of being provides a physical barrier to the environment. contaminated every time you open the jar and GAVIETA,ZA.7 | P a g e VEHICLE- a carrier or inert medium used as solvent or diluent in which active pharmaceutical agent is formulated and or administered GAVIETA,ZA.8 | P a g e