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Pharmaceutics II:EII
Hussains section
| Question | Answer |
|---|---|
| What are powders? | Homogeneoues mixtures of dry, finely ground drugs that are intended for both external or internal application. |
| Define Granules. | Aggomerates of powered material, which are used in the preparation of tablets. |
| Describe the general usage of powders in various dosage forms. | Raw materials for several dosage forms Tablets and Capsules=Ingredient with diluents and other ingredients Solution and Suspensions= Dissolved or suspended Ointments and Creams=Incorporated into semisolid bases |
| List the two methods of preparing powders (and define them) and industerial equipment that accomplish this. | Comminution-Particle size reduction (or grinding and pulverization) -Mill Blending- The mixing of more than one solid (usually active drug and diluant). -V-blender -Small scale: Morter and Pestle (trituration) and Spatula and glass slab spatulation |
| Define Capsules | A solid dosage form in which drug substances are enclosed in a small gelatinous or cellulose shell. |
| What are the two types of gelatin and their similarities and differences? | Type A and B Type A= Hydrolysis of collagenous material, acid processing Type B= Hydrolysis of collagenous material, base processing. |
| What are the two types of capsules? | Hard and soft |
| List the size ranges and corresponding estimations of amounts of capsule sizes. | 5 (smallest and 30mg)- 000 (largest and 600mg) **Weights depend on powder density** |
| List the four Compendial Requirements for Capsules. | Container Weight variation Content uniformity Labeling |
| List important information for Container and Weight Variation requirments for capsules. | Container- USP lists container specifics, which can include well-closed, light resistant, etc. Weight Variation- HGCs and SGCs similar. Ten capsules picked Calc:Ind. capsules wt full-Ind. cap wt empty. Should be within monograph limits. |
| List important information for Content Uniformity and Labeling requirments for capsules. | Content Uniformity- 10 units measured and amount of active ingredient should be within 85-115%. Labeling- Labeled to reflect the quantity of each dosage unit. |
| Important points for HGCs. | -Rigid and firm (made of gelatin, sugar, water) -Shouldn't be stored in high humidity (become lose rigidity) or very low humidity (become brittle and crumble) -May be filled with powder, granulates, small tablets or capsules. |
| Important points for SGCs. | -Soft, pilable capsule shell (thicker than HCG) -Oblong, oval, or round in shape. -Holds liquids, suspensions, pastes, powders, and tablets. -Plasticized by + of glycerin, sorbitol, or polyol. - Contain more moisture so add preservative. |
| List the three main types of suppositories | Rectal Vaginal (and Vaginal inserts) Urethral |
| List the shape and weight of rectal suppositories. | 1.5 inches long, weigh 2g, cylindrical, and have a tapered end. (Infants are 1/2 the weight.) |
| List three examples of rectal suppositories. | 1. Dulcolax (Bisacodyl) 2. Thorazine (Chlorpromazine) 3. Anusol-HC (Hydrocortisone) |
| Another name for vaginal suppositories. | pessaries |
| Configuration of vaginal suppositories. | Globular or oviform and weigh about 5g. |
| True or Flase: Vaginal suppositories require an applicator. | True |
| List three common vaginal pathogens | 1. Trichomonas vaginalis 2. Candida albicans 3. Haemonphilus vaginalis |
| List four examples of commercially available pessaries. | 1. Cleocin (Clindamycin phosphate) 2. Monistat (Miconazole nitrate) 3. Semicid (Nonoxynol-9) 4. Estrogenic substances like dienestrol |
| True or false: Vaginal inserts are easier to manufacter and more stable than vaginal suppositories | True |
| List three examples of vaginal inserts. | 1. Vagifem (Estradiol) 2. Mycostatin (Nystatin) 3. Canesten tablets (Clotrimazole) |
| Another name for Urethral Suppositories. | Bougies |
| Configuration of urethral suppositories | Cylindrical in shape and slendar (5mm in diameter) |
| Use of urethral suppositories. | 1. Local infections 2. erectile dysfunction |
| What are the 3 types of suppository bases | 1. Cocoa butter-fatty bases 2. Water-soluble - water-dispersible 3. Hydrogels |
| List the different crystal forms of theobroma oil and the heating parameters. | alpha, gamma, beta', beta; Keep heat below 45C, but above 60C then the metastable alpha form is crystallized. |
| True or False Cocoa butter offers the decreased potential for rancidity and phase transitions compared to hard fats and saturated vegetable oils. | False. |
| PEG bases are used frequently in which suppository? | Vaginal |
| What are the advantages to water-soluble bases? | 1. Used for prolonged action compounds. 2. Less messy than cocoa butter 3. Don't melt at body temperature but dissolve in the body's fluid. 4. No refrigeration. |
| How to hydrogels release active compounds? | They absorb water and their macromolecular networks swell releasing active drug. |
| What are the three methods of suppository preparation? | 1. Rolling (Hand-shaping) 2. Compression 3. Molding (Fusion) |
| Define Semisolid | Dosage forms pertaining to the use of ointments, creams, lotions, and gels as drug delivery systems. |
| Semisolid dosage forms are also know as topical dosage forms, true or false? | True |
| What are the four main ointment bases? | 1. Oleaginous base (aka. Hydrocarbon base) 2. Absorption base 3. Water-removable base (aka Water-Washable base) 4. Water-soluble base (aka Greaseless base) |
| Important points about the Oleaginous Base. | -Immiscible with water -Cannot be removed easily from the skin -Can only incorporate small amounts of aqueous drug -Keeps skin hydrated by dehydration prevention -Ex. Petrolatum, white petrolatum, white and yellow ointment. |
| Important points about Absorption bases. | -Result in W/O emulsions -Emollient effects (less than oleaginous base) -Hard to wash off -Ex. Hydrophilic Petrolatum and lanolin |
| Important Points about Waster-removable bases. | -O/W emulsions -Easily removed from skin -Water dilution can be accomplished -Ex. Hydrophilic ointment |
| Important points about Water-soluble bases. | -No oleaginous components -Mostly for solids -Ex. PEG |
| Two methods for ointment preparation. | 1. Incorporation 2. Fusion |
| List the general compemdial Ointment requirements. | Meet tests for: 1.Microbial content 2. minimum fill 3.packaging 4. storage 5. labeling If opthalmic: Additional tests for microbial growth and metal particles. |
| Important points about creams | -Usually o/w, rarely w/o -reflect light creamy -Easy to remove and dry out skin |
| Define specifics about gels | -Thixotrope -dispersions of molecules in an aqueous vehicle with a jelling agent. -Ex. Hydro.-methylcellulose (or CMC), natural gums (tragacanth), and carbomer 934. |
| Name four other semisolids and a common example. | -Pastes (zinc oxide paste) -lotions (antimicrobial) -plasters (salicylic acid for corns) -glycerogelatins (zinc gelatin for ulcers) |
| List the routes of administration which require ointment applicators. | ophthalmic, nasal, aural, rectal, or vaginal |
| What are the three dispensing containers? | Jars, tubes, and syringes |
| What are the three main ingredients to make effervescent dosage forms | Sodium bicarbonate, citric acid, and tartaric acid (makes CO2 bubbles). |
| What is the dosage form that is the most widely used, has the best ease of administration, and is very stable? | Tablets |
| In a multi-layer tablet what is the core inner and outer portion called? | core and shell (respectively) |
| What are the nine forms of tablets? | Compressed, multiple compressed, sugar coated, Film coated, Gelatin coated, Enteric coated, Buccal and sublingual, chewable, and effervescent. |
| What are diluents and what are examples? | Compounds used to increase bulk to make tableting possible. Ex. dicalcium phosphate, lactose, cellulose, kaolin, mannitol, dry starch, and powdered sugar. In chewables, sugar alcohols-mannitol, soritol, and inositol. |
| What are binders and what are examples? | They bind all tablet ingredients together and prevent breakage after compression. Ex. starch, gelatin, sugars- sucrose, latose, and dextrose, molasses, gums such as acacia and veegum. |
| What are lubricants and what are examples? | They prevent adhesion and facilitate ejection from dies and punches; and reduce interparticle friction. Ex. talc, magnesium stearate, calcium stearate, vegetable oil, and PEGs. |
| What are glidants and what are examples? | They improve flow properties of powders. ex. Cab-o-sil and talc |
| What are disintegrants and what are examples? | They help break-up or disintegrate tablet after adm. Ex. Starch, clay, cellulose, and gums are examples of this class |
| What are colorants and what are examples? | They help identify tablets. EX. D and C (Drug and cosmetic) Red 40 or F,D,& C (Food, drug, cosmetic) Red 40 |
| What are flavorants and what are examples? | They flavor usually chewable or subling/buccal tabs. Lactose, mannitol, and aspartame. |
| What are the three types of tab preparation? | 1. Direct compression 2. Wet granulation 3. Dry granulation |
| What are the five processing problems? | Capping- loss of top or bottom Lamination- separation of two or more pieces Picking- Punch removes part of tab Sticking- tab sticks to die Mottling- color uneven. |
| Can enteric coated or controlled release products be split? | No |
| What are the components of a sugar coated tab? | Shellac, zein, or cellulose acetate phthalate is used for waterproofing; syrup for subcoats;Gelatin, acacia or PVP is included in the coating mixture. |
| What are the components of a film coated tab? | Cellulose polymers and acrylic copolymers. |
| What are the components of a enteric coated tab? | pharmaceutical shellac, hydroxypropyl methyl cellulose phthalate, poly vinyl acetate phthalate, and cellulose acetate phthalate--resist harsh stomach environment and degrade at higher pH. |
| What are the compendial requirements for tabs.? | -Weight variation (20 tabs used see notes for scale) -content uniformity (85-115% of label for 10 tabs.) -Hardness (doesn't break up to 4kg) -Friability (wt. loss less than 1% in friabilator) -Disintegration(30 min but can be 2mins (NTG)-4hours buccal |
| What are the other tab dosage form and examples? | -Lozenges (benzocaine, dextromethorphan, phenyl propanolamine) -Lollipops (fentanyl actiq-Cephalon) -Pills (sames as tabs. and caps) |
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