Block 4 -- Drug Product Development Flashcards by Drew Spargo

What are the 3 steps in manufacturing?

1) preformulation
2) formulation
3) manufacturing

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What classification in the BPC are most pharmaceuticals?

BPC 2 & 4 (solubility-limited)

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What are types of crystalline defects?

1) interstitial atom
2) substitutional atom
3) vacancy
4) frenkel pair

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What is “alpha” in the Prout-Tompkins equation?

alpha = the fractional extent of the reaction

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What are the types of degradation reactions?

1) Hydrolysis
2) Oxidation
3) Photolysis
4) Dehydration

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What is the IPEC definition for an excipient?

Compounds other than API that have been evaluated for safety, and have any of the following roles:

1) aid in processing
2) aid in stability, F, patient acceptability
3) aid in Product ID
4) contribute any other attribute for safety/efficacy

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What is the IPEC?

International Pharmaceutical Excipients Council

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How are most excipients currently obtained?

Synthesis

Physical modifications of natural compounds

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What is the purpose of diluents?

bulking agents

- practical weight
- compression aid
- improve powder flow

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What are examples of diluents?

1) Microcrystalline cellulose
2) Lactose
3) Calcium phosphate dibasic dihydrate
4) Starch
5) Compressible sugar

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What is the Mallard reaction?

Reducing sugar (lactose) reduces API

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What is the purpose of disintegrants?

break up drug product to enhance dissolution

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What are examples of disintegrants?

1) Sodium starch glycolate
2) Croscarmellose sodium
3) Crospovidone
4) Starch

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What are the purposes of binders?

- mechanical strength

- - creation of granules in wet milling

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What are examples of binders?

1) Polyvinylpyrrolidone (PVP)
2) Starch
3) Microcrystalline cellulose
4) Polymers

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What purposes do lubricants serve?

1) prevents adherence to die

What are examples of lubricants?

1) Mg Stearate
2) Stearic acid
3) Lubritab (hydrogenated vegetable oil)
4) Talc

How are lubricants used in manufacturing?

- added right before addition to dye

- - levels normally 0.5 - 2%

What is the purpose of a glidant?

1) improved flow

2) reduce inter-particle friction

What are examples of glidants?

1) fumed silica

2) talc

How are glidants used in manufacturing, and what are some concerns?

- normal levels <0.2%, very fluffy

- - can have asbestos contamination

What agents are used for controlled release?

1) hydroxypropylmethylcellulose (HPMC)

2) Xanthan gum

What are examples of protectants?

Eudragits– Polymethylacrylates

Describe the points in manufacturing where excipients are added.

All are during final mixing with these exceptions:

1) filler during initial mixing
2) binder during wet granulation

What are the criteria for tablet manufacture?

1) dose uniformity 2) disintegration, dissolution 3) uniform coating 4) mechanical strength 6) stable, soluble, easy to administer

List the unit operations:

1) Weighing 2) Blending/Mixing 3) Milling 4) Granulation 5) Drying 6) Compaction 7) Coating 8) Packaging

What machines are used for blending?

y,cone, rotating cube, double cone, oblique cone, v mixer, turbula, bowl mixer, slant cone

What methods are used in milling?

cutting compression impact attrition

What machines are used in milling?

Fitz Mill | CoMill

What are the purposes for granulation?

1) better mixing 2) improved flow 3) avoid toxic dust 4) lessen impact of moisture

What machines are used in wet granulation?

1) high speed mixer | 2) fluidized-bed granulator

What are the methods used in dry granulation?

slugging | roller compaction

How is size selected in dry granulation?

Selective screen size

What are the steps in tablet formation?

1) dye filling 2) tablet formation 3) ejection

What machines are used in tablet manufacture? Describe their qualities.

1) Tablet Presses - - single punch, 200/min 2) Rotary Presses - - multi-punch, 10k/min

What tests are used after tablets are manufactured?

thickness, hardness