2)Crude Drugs

Question 1

What are Crude Drugs?

Answer 1

They consist of natural substances (animal/plant origin)

They have undergone only the processes of collection + drying

Sources include:

• Plants - Senns, Digitalis, Datura, Clove etc
• Animal - Honey, Cod lover oil, Musk etc
• Marine - Sponges, Agar etc
• Mineral - Talc, Kaolin

Question 2

Uses of Crude Drugs

Answer 2

• Treatment of a wide ranges of diseases
• Pharmaceutical aids
• Cosmetics - flavouring + colouring agents
• Culture media of propagation of MOs

Question 3

Classification of Crude Drugs

Answer 3

1. Alphabetically - shows no indication of interrelationships between drugs
2. Taxonomical - According to Classes, Orders, Families etc
3. Morphological - divides into leaves, flowers, fruits, seeds, herbs etc
4. Pharmacological - Grouped according to pharmacological action
5. Chemical - According to chemical constituents

Question 4

Production

Answer 4

1. Collection
2. Drying - Decreases size + facilitates powdering
3. Storage - Drugs affected by light, moisture, temp, o2 etc

• Long term storage not recommended due to deterioration - therefore should be sealed in containers in cool, dark places

Question 5

Stages in drug discovery + development

Answer 5

Drug discovery is expensive + lengthy - it can take upto 10-12 years

Question 6

Stage 1 - Discovery + exploratory research

Answer 6

Researchers discover new drugs through:

• New insights into a disease process - can help design a new product to stop effects of disease
• Tests of Molecular compounds
• New tech - manipulating genetic material

Question 7

Stage 2 - Research phase

Answer 7

Initial molecules are further tested to check for drug viability + effectiveness

• How it is absorbed, distributed, metabolised + excreted
• Benefits + mechanism of action
• Best dosage
• Side effects

Question 8

Stage 3 - Preclinical Phase

Answer 8

Before testing on people, we must find out if the drug has potential to cause serious harm:

• In vitro - on isolated organs/tissues
• In vivo - on live animals
• The drug is manufactures in small amounts w/data collected - to determine the pharmacodynamics + pharmacokinetics

Question 9

Stage 4 - Clinical development

Answer 9

Phase 1 trials (6-9 months)

• 1st studies on humans
• small group of healthy volunteers (20-100)
• Observation + recording of PD effects, PK properties, tolerability, toxicity etc

Phase 2 trials ( 6 months - 3 years)

• Performed on 100-200 patients suffering from condition
• Trials determine PD effects in patients + establishes effective dosages

Phase 3 trials (1 - 4 years)

• 1000-3000 patients all suffering from condition
• Provides expanded testing of effectiveness + safety of drug

Phase 4 trials

• post-marketing testing to detect any rare/long-term adverse effects
• pattern of drug utilisation is also discovered