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DDS Final > Excipients - Plant Extractives > Flashcards

Excipients - Plant Extractives Flashcards

1
Q

What is a pharmaceutical excipient?

A

Any substance other than the active drug or prodrug that is included in the manufacturing process or is contained in a finished pharmaceutical dosage form

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2
Q

What are characteristics of ideal excipients?

A 
Non reactive with the drug
Non toxic
Inert 
Chemically and physiccally stable
Cheap and easy to manufactor
Approved by FDA
Pleasing organoleptic
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3
Q

What are classes of excipients?

A 
Pharmaceutical solvents
Solubilizing agents
Preservatives
Antioxidants
Buffers and pH adjusting agents
Tonicity adjusting agents
Viscosity inducing agents
Scents, Colors, Flavors & sweeteners
Ointment and suppository bases
Binders 
Diluents/Fillers for solid dosage forms
Disintegrating agents
Coating Agents
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4
Q

What are pharmaceutical solvents?

A

Used as a wehicle for liquid formulation
Water is the most common and most desirable
Alcohols like ethyl alcohol and isopropyl alcohol are examples
Gylcols, ketones, and oils are examples as well

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5
Q

What are solubilizing agents?

A

Substances that are used to increase the solubility of a drug active component
Organic solvents, amphiphilic substances, complexing agents are all examples

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6
Q

What are preservatives?

A

Added to non-sterile dosage forms to protect from microbial growth and microorganisms introduced during the manufacturing process
Also added when there is a possibility of microbial contamination while compounding or during patient/caregiver use: multiple dose containers, most water containing dosage forms, and ophthalmic ointments

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7
Q

When are preservatives not necessary?

A

The preparation will be used immediately, no water is present, the pH is between 3 and 9 or there is antimicrobial ingredient already present

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8
Q

Preservatives are contraindicated in what?

A

Neonates, ophthalmic solutions for intraocular injection or for use during eye surgery, or parenteral products with less than 30 mL

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9
Q

What are the ideal preservative properties?

A

Effective at low does, broad spectrum, chemically stable, compatible with variety of drugs

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10
Q

What are the oral dosage form preservatives?

A

Alcohols and glycols, organic acids, parabens

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11
Q

What are the topical preparation preservatives?

A

Alcohols and glycols, organic acids, parabens, and organic mercurial derivatives

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12
Q

What are topical preparation preservatives?

A

Salts of quaternary ammonium bases (benzalkonium chloride)

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13
Q

What are ophthalamic preparation preservatives?

A

MUST BE STERILE, multidose containers must contain preservatives

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14
Q

What are antioxidants?

A

Added to dosage form to protect from chemical degradation caused by oxidation

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15
Q

What are antioxidants in aqueous systems?

A

Ascorbic acid (Vitamin C)

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16
Q

What are antioxidants in oil systems?

A

Vitamin E

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17
Q

What are chelating agents?

A

Organic compounds that can form complexes with metal ions and inactivate the catalytic activity of the metal ion in the oxidation process (citric acid, EDTA)

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18
Q

What are buffers?

A

Compound or a mixture of compounds that, when in a solution, resists change in the pH of the solution with small quantities of acid or base are added

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19
Q

What are pH adjusting agents?

A

Agents that are used to adjust the pH of a solution

Increase bioavailability and stability of the drug

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20
Q

What are tonicity adjusting agents?

A

Agents that are used to provide physiological osmotic pressure to a solution or formulation (parenterals, ophthalamics and nasal solutions)

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21
Q

What is viscosity?

A

A measure of resistance to flow of a system under an applied stress

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22
Q

What are viscosity inducing agents?

A

Substance that provide a certain resistance to flow,
Enhance the flavor or “mouth feel” of liquid oral drugs
Semisynthetic cellulose derivatives: Methycellulose (clear odor-less gel) or carboxymethylcellulose

23
Q

What are colors?

A

Any dye, pigment, or substance that can impart color when added or applied to food or drug
Improve patient acceptance

24
Q

What are Natural colors?

A

Plant pigments or mineral pigments

25
Q

What are synthetic dyes?

A

aniline dyes or coal tar dyes

26
Q

What is flavor?

A

added to oral dosage forms to improve patient acceptance of the preparation
Different age groups = different taste preferences

27
Q

What is scent?

A

usually added to topical preparations to improve their aesthetic appeal

28
Q

What are sweeteners?

A

Agents that are added to mask or reduce unpleasant taste of a drug by increasing the sweetness of the preparation
Polyhydroxy compounds and saccharin compounds

29
Q

What are ointment bases?

A

semisolid substances used as vehicles for ointments
Hydrocarbon: petrolatum and white petrolatum
Absorption: Lanolin or eucerin
Water removable: velvachol
Water soluble: polyehtylene glycol

30
Q

What are suppository bases?

A

Supositories should melt, soften or dissolve at body temperature
Cocoa butter, cocoa butter substitutes, glycerinated gelatin, polyethylene glycol base, surfactant base, tableted suppositiories or inserts

31
Q

What are diluents/fillers?

A

Facilitate the process of tablet manufacturing, the tablet should not be lighter than 50 mg and not smaller than 3 mm in diamter
Inert substance that are added to tablet or capsules dosage forms to produce a product of reasonable size: startch, lactose, dibasic calcium phosphate, microcrystalline cellulose

32
Q

What are binders?

A

substances that are added to promote cohesion between formulation components of tables: gelatin, acacia

33
Q

What are disintegrating agents?

A

Used to enhance the breakup or disintegration of tablet when it comes in contact with the fliud of the GI tract

34
Q

What are coating agents?

A

Substances that are used to coat tablets or granules in order to serve a specific purpose such as stability, release profiles or cosmetic aspects
Film coating: hydroxypropyl methylcellulose
Sugarcoating: sugar and others
Enteric coating: cellulose acetate phthalate

35
Q

What are controlled release excipients?

A

Carboxymethyl cellulose

36
Q

What are anti frictional agents?

A

lubricants, antiadherants

37
Q

What are suspending/wetting agents?

A

facilitate wetting of hydrophobic substances

38
Q

What are emulsifying agents?

A

Facilitate contact between water and oil

39
Q

What is alligation medial?

A

Used to find the quantity of a mixture given the quantities of its ingredients

40
Q

What is alligation alternate?

A

used to find the quantity of each ingredient to prepare a mixture of given quantity or strength

41
Q

What is Active Pharmaceutical Ingredients?

A

a substance or compound intended to be used in the manufacturing of a pharmaceutical product as a therapeutically active compound

42
Q

Drug products are considered pharmaceutical equivalents if they contain what?

A

the same acive ingredient (s), have the same dosage form and route of administration and are identical in strength or concentration
They may differe in in characteristics such as shape, release mechanisms, excipients, and packaging

43
Q

Drug products are considered pharmaceutical alternative if they contain what?

A

the same therapeutic moiety but are different salkts, esters, or complexes of the same moiety, are different dosage forms, or differnt strengths

44
Q

What is an active drug moiety?

A

The chemical capable of producing pharmacological or therapeutic effects
May come in a weak acid, weak base, salts of acid or base, hydrous or anhydrous form, ester forms or various complexes forms

45
Q

What is a pharmaceutical salt?

A

an ionic compound who cation comes from a base and whose anion comes from an acid

46
Q

Why are salts important?

A

The characteristics of a drug can be modified without altering the chemical structure by conversion to a new salt form: each salt imparts unique properties to the parent compound

47
Q

What does the Dietary Supplement Health and Education Act state?

A

Dietary supplements are not regulated or tested like drugs
Manufactureres are free to market supplements without proof of safety or efficacy
No FDA approval needed to sell
No established dosage guidelines
No purity restrictions

48
Q

What are plant extractives?

A

Plant materials that are intended to be used as drugs (botanical drugs)

49
Q

What is maceration?

A

comminuted crude druge is placed in a solvent and allowed to soak. Next, the dissolved constituents are separated by fitltration

50
Q

What is percolation?

A

Communited drug is extracted by the slow passage of the solvent through a column of the botanical material

51
Q

What are the primary dosage forms of plant extractives?

A

Extracts
Fluidextracts
Tinctures

52
Q

What are extracts?

A

Concentrated preparations of botanical drugs; available in solid (powedery consistencty–>evaporation of the solvent) or semisolid forms (partial evaporation)

53
Q

What are fluidextracts?

A

Liquid extractives of plant materials adjusted for drug content so that 1 mL is equivalent to 1 gram of the crude drug through percolation

54
Q

What is tinctures?

A

Liquid extractives of plant materials adjusted for drug content so that 10 mL is equivalent to 1 gram of the crude drug through percolation or maceration with a solvent that is alcohol or hydro-alcoholic mixture

DDS Final (8 decks)

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