Ita -- novel dosage forms
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132 terms
Terms | Definitions |
|---|---|
 how is the magic bullet concept of novel drug delivery accomplished | by increasing target concentrations and reducing exposure of non-target cells, this is accomplished |
| two categories of mechanism on which novel dosage forms based | physical and biochemical mechanisms are the two mechanisms for this |
| osmosis (type of mech) | physical |
| diffusion (type of mech) | physical |
| erosion (type of mech) | physical |
| dissolution (type of mech) | physical |
| electrotransport (type of mech) | physical |
| monoclonal antibodies (type of mech) | biochemical |
| gene therapy (type of mech) | biochemical |
| vector systems (type of mech) | biochemical |
| polymers (type of mech) | biochemical |
| liposomes (type of mech) | biochemical |
| examples of naturally derived substances used for novel delivery system's formulation | gelatin and sugars |
| ___ can be used to attach an active drug to a synthetic or naturally-occurring polymer | degradable bonds can be used to _______ |
| 4 limitations of polymers | high molecular wt (slow excretion from body), slow permeability due to size, possibility of toxic or immunologic rxns, structure complex-labor intensive and expensive |
| dosage forms of lamictal | 2, 5 or 25mg |
| lamictal contains? type of drug? | lamotrigine , antiepileptic |
| calcium carbonate | lamictal (inactive ingredient), videx chewable dispersible buffered tablet (buffer) |
| black currant flavor | lamictal |
| low-substituted hydroxylpropylcellulose | lamictal |
| magnesium aluminum silicate | lamictal |
| magnesium stearate | lamictal (inactive), videx (contained in the tablet matrix) |
| povidone | lamictal |
| saccharin sodium | lamictal |
| sodium starch glycolate | lamictal |
| didanosine brand name? | Videx |
| 3 dosage forms of Videx | chewable dispersible buffered tablet, buffered powder for oral solution and a pediatric powder for oral solution are the 3 dosage forms for this med |
| what is videx? | this drug is a synthetic purine nucleoside analogue active against HIV |
| available dosage strengths for videx chewable dispersible buffered tab? | 25, 50, 100, 150, 200mg |
| magnesium hydroxide | Videx chewable dispersible buffered tablets (buffer) |
| aspartame | videx chewable (contained in the tablet matrix) |
| sorbitol | videx chewable (contained in the tablet matrix) |
| microcrystalline cellulose | videx chewable (contained in the tablet matrix) |
| polyplasdone | videx chewable (contained in the tablet matrix) |
| mandarine orange flavor | videx chewable (contained in the tablet matrix) |
| chemical name for didanosine | 2', 3' - dideoxyinosine |
| didanosine at a pH of less than __ at body temp, __% of didanosine decompose to ____ in less than ___ min | pH < 3, 10% to hypoxanthine in < 2 min |
| because didanosine is unstable in acidic solutions, we have ___ in the chewable tabs, and in one of the oral solutions | buffering agents |
| other than buffering agents, what else protects videx from acidic contents of stomach | enteric coating (Videx EC Delayed-Release Capsules) |
| to achieve extended rates of drug action following injections, what drug forms are used that have prolonged dissolution characteristics | amorphous or crystal drug forms have ____ characteristics, so used to achieve ______ |
| to achieve extended rates of drug action following injections, solutions or suspensions of the drug are in ____, example? | they are in slowly absorbed carriers or vehicles, example oleaginous vehicles |
| to achieve extended rates of drug action following injections, ____ particles of drug in suspension | large particles of drugs in suspension in order to achieve this |
| to achieve extended rates of drug action following injections, injection of ______ | slowly eroding microspheres injected to achieve this |
| in long acting parenteral systems, example of material used as a matrix | purified insoluble collagen |
| in long acting parenteral systems, matrix releases drug contents through ____ and _____ | controlled diffusion and enzymatic matrix degradation |
| Lupron Depot (type) | long-acting parenteral system |
| Depo-Provera (type) | long-acting parenteral system |
| Decadron LA | long-acting parenteral system |
| Neulasta generic? | pegfilgrastim |
| Filgrastim | recombinant methionyl human granulocyte colony-stimulating factor |
| Neulasta is a covalent conjugate of ____ and ____ | Filgrastim and monomethoxy polyethylene glycol (PEG) |
| Pegfilgrastim is produced by? | this is produced by covalently bonding a 20kD PEG molecule to the N-terminal methionyl residue of filgrastim |
| Neulasta indictated to? | this is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients w/ nonmyeloid malignancies receiving myelosuppressive anticancer drugs |
| pegasys generic? | peginterferon alpha-2 |
| pegasys used in the treatment of ___ | this drug is used in hepatitis C virus infection |
| pegasys is a covalent conjugate of ____ (MW?)w/ a single ___ ____ chain w/ the molecular weight of approx ____ | recombinant alpha-2a interferon (mw 20kD) w/ a single branched bis-PEG chain w/ the mw of approx 40kD. this is this medication |
| Abelcet injection is? consists of? complexed w/? what is the drug-to-lipid molar ratio? | this is a sterile, pyrogen-free suspension for IV infusion consisting of amphotericin B complexed w/ two phospholipids in a 1:1 drug-to-lipid molar ratio |
| what are the two phosopholipids in Abelcet injection? molar ratio of the two lipids? | L-alpha-dimyristoyl phosphatidylcholine (DMPC) and L-alpha-dimyristoyl phosphatidylglycerol (DMPG); present in a 7:3 molar ratio |
| color of Abelcet injection, pH? | yellow and opaque w/ a pH in the range of 5 to 7 is this drug |
| how much amphotericin B in Abelcet injection per milliliter? | 5mg/ml of this in Abelcet |
| how much DMPC in Abelcet injection per milliliter? | 3.4mg/ml of this in Abelcet |
| how much DMPG in Abelcet injection per milliliter? | 1.5mg/ml of this in Abelcet |
| how much sodium chloride in Abelcet injection per milliliter? | 9mg/ml of this in Abelcet |
| how much water for injection in Abelcet injection per milliliter? | 1ml of this in Abelcet |
| what is amphotericin B liposome for injection | AmBisome |
| AmBisome is -----? | a sterile, nonpyrogenic lyophilized product for IV infusion |
| how much amphotericin B contained in one vial of AmBisome | 50mg |
| amphotericin B in AmBisome is in what form? | it is intercalated into a liposomal membrane |
| in AmBisome, how much hydrogenated soy phosphatidylcholine are there | 213mg |
| in AmBisome, how much cholesterol are there | 52 mg |
| in AmBisome, how much distearoyl phosphatidylglycerol are there | 84 mg |
| in AmBisome, how much alpha tocopherol are there | 0.64 mg |
| in AmBisome, how much sucrose are there | 900mg |
| in AmBisome, how much disodium succinate hexahydrate are there | 27mg |
| pH of solution when AmBisome reconstituted w/ sterile water | bt 5 to 6 |
| what kind of drug delivery system is AmBisome | this is a true single bilayer liposomal drug delivery system |
| when the AmBisome powder is reconstituted, what are formed, then what happens | when this happens, multiple concentric bilayer membranes are formed, these membranes are changed by microemulsification into single bilayer liposomes using a homogenizer |
| how big are the liposomes contained in AmBisome | 100 nm in diameter |
| describe aphotericin B | it is a macrocyclic polyene antifungal antibiotic that is produced from a strain of Streptomyces nodosus |
| Amphotec generic? | amphotericin B cholesteryl sulfate, Sequus Pharmaceuticals |
| describe Amphotec | this is a sterile, pyrogen-free lyophilized powder for reconstitution and IV administration |
| amphotec is a complex of what and what? ratio? reconstitution of it forms? | this is a 1:1 molar ratio complex of amphotericin B and cholesteryl sulfate that upon reconstitution forms a colloidal dispersion of microscopic disk-shaped particles |
| in each 50mg single-dose vial of Amphotec, how much amphotericin B are there | 50mg |
| in each 50mg single-dose vial of Amphotec, how much sodium cholesteryl sulfate are there | 26.4mg |
| in each 50mg single-dose vial of Amphotec, how much tromethamine are there | 5.64mg |
| in each 50mg single-dose vial of Amphotec, how much disodium edetate dihydrate are there | 0.372mg |
| in each 50mg single-dose vial of Amphotec, how much lactose monohydrate are there | 950mg |
| hydrochloric acid is an ingredient in? | amphotec |
| Amphotec is indicated for the treatment of ___ in pts w/ ____ | this drug is indicated for the treatment of invasive aspergillosis in pts w/ renal impairment |
| Amphotec is also useful when unacceptable toxicity precludes the use of this med in effective doses | this is useful when unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses |
| in aspergillosis pts when prior amphotericin B deoxycholate therapy has failed, this is useful | Amphotec |
| what is the only fluid Amphotec should be reconstituted w/ for injection | sterile water (added rapidly) |
| for Amphotec injection, what do you do after resconstitution? | for infusion, you further dilute the product in 5% dextrose injection after reconstituting with sterile water |
| Amphotec should not be reconstituted w/ ___ or ___ solutions | this product should not be reconstituted w/ dextrose or sodium chloride solutions |
| for further dilution of Amphotec (after reconstitution), it should not be admixed w/ ___ or ____ | for further dilution, this product should not be admixed w/ sodium chlordie or electrolytes |
| solutions containing ____ or any other ____ agent should not be used in Amphotec as they may cause precipitation | solutions containing benzyl alcohol or any other bacteriostatic agent should not be used as they may cause this problem |
| what device should not be used in Amphotec infusion | an in-line filter should not be used and infusion admixture should not be mixed w/ other drugs |
| what do you need to do before and after infusion of Amphotec when using a Y-injection site or similar device | if infusing Amphotec using this kind of device, you need to flush the line w/ 5% dextrose injection before and after infusion of Amphotec |
| after reconstituting Amphotec, the drug should be ____, and used w/in ___ hrs | after this, the drug should be refrigerated and used w/in 24 hrs, DO NOT FREEZE |
| Daunorubicin citrate liposome injection (brand?) | DaunoXome, NeXstar Pharm. |
| DaunoXome is an aq solution of _____ encapsulated w/ _____ composed of _____ and ____ (ratio?) | daunorubicin citrate, liposomes, distearoyl phosphatidylcholine and cholesterol (2:1 molar ratio) |
| diameter of liposomes in DaunoXome? | 35-65 nm |
| lipid to drug wt ratio ____ in total lipid-daunorubicin is equivalent to a ___ molar ratio of distearoyl phosphatidylcholine, cholesterol and daunorubicin | 18.7:1, 10:5:1 |
| DaunoXome is formulated to maximize what? | it is formulated to maximize the selectivity of daunorubicin for solid tumors in situ |
| liposomal formulation in DaunoXome helps to protect the ____ from ____, minimizes ____ and generally decreases ____ | this formulation helps to protect the daunorubicin from chemical and enzymatic degradation, minimizes protein binding and generally decreases uptake by normal tissues |
| DaunoXome should be diluted in what ratio w/ what prior to administration | it should be diluted 1:1 w/ 5% dextrose injection prior to administration |
| each vial of DaunoXome contains the equivalent of how much daunorubicin base at a concentration of what after preparation | 5mg, 2mg/ml |
| it is recommended to dilute DaunoXome to what conc for administration | 1mg/ml |
| the only fluid recommended for preparation of DaunoXome is ___ | 5% dextrose injection |
| 5% dextrose injection for preparing daunoxome must not be mixed w/ a solution containing ___ or ___ or ___ | sodium chloride or benzyl alcohol or w/ any other solution |
| what device should not be used for IV infusion of daunoxome | an in-line filter |
| describe final product of daunoxome | a red translucent dispersion of liposomes that does scatter light , product should not be used if it appears opaque or has precipitate or foreign matter in it |
| DaunoXome storage temp? | stored in fridge (2-8C, 36-46F), should not be frozen, should be protected from light |
| Doxil generic? | Doxorubicin hydrochloride |
| Doxil liposomes consist of the drug encapsulated in _____ liposomes for IV administration | Stealth liposomes |
| what type of drug is Doxil? | it is a cytotoxic anthracycline antibiotic that is isolated from Streptomyces peucetius var. caesius |
| Doxil is available as translucent ___ (color) liposomal dispersion containing in each __ml single-use glass vial __mg doxorubicin HCl at a pH of ___ | red, 10ml, 20mg, 6.5 |
| how much N-(carbonyl-methoxy polyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt is consisted in stealth liposomes | 3.19mg/ml |
| how much of fully dehydrogenated soybean phosphatidylcholine is consisted in the stealth liposomes | 9.58mg/ml |
| how much of cholesterol is consisted in stealth liposomes | 3.19mg/ml |
| in Doxil, each ml contains approx how much of this ingredient as a buffer | 2mg of ammonium sulfate w/ histidine as a buffer |
| what is used for tonicity in doxil? | sucrose is used for this in doxil |
| what is used for adjustment of pH in Doxil | HCl and or NaOH are used for this in Doxil |
| how many percent of doxorubicin is encapsulated in the Stealth liposomes | 90% |
| how are the Doxil liposomes protected from detection by the mononuclear phagocyte system | through coating with surface-bound methoxy polyethylene glycol, doxil liposomes are protected from this |
| half life of doxil liposomes? | 55 hrs in humans |
| Enbrel generic? | Etanercept |
| what is Enbrel? | a recombinant human soluble TNF-a receptor fusion protein |
| MW of Enbrel? | 150 kDa |
| Enbrel is useful in what kind of disorders? | disorders involving excess inflammation in humans and other animals |
| doseage strength available for Enbrel? | 25mg (0.51ml of a 50mg/ml solution of etanercept) and 50mg (0.98ml of a 50mg/ml solution of etanercept) |
| Enbrel single-use prefilled SureClick autoinjectors are available in __mg | 50mg (0.98ml of a 50mg/ml solution of etanercept) |
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