EXERCISE 3-1_SOURCES OF DRUG INFORMATION.pdf

Sources of Drug Information

1. SOURCES OF DRUG
INFORMATION EXERCISE NO. 3
Group 4:
Alonzo, Baloco,
Candelasa, Jovita

2. At the end of the practical class the
student shall be able to:
1. List unbiased sources of drug
information
2. Select the appropriate source of
drug information depending on the
information required.
3. Appreciate the merits and
limitations of the various sources.
OBJECTIVES:

3. GROUP 1

4. British Pharmacopeia,
Indian Pharmacopeia
Task 1: What is the composition of
Lugol’s Iodine Solution?
Lugol’s iodine solution as specified by the FDA’s
Bacteriological Analytical Manual (BAM R40):
Composition (per 100 mL of solution – BAM R40)
Potassium iodide (KI): 10 g
Iodine (I₂): 5 g
Distilled water: to make total volume up to 100
mL.

5. How is it prepared? Dissolve KI in about 20-30 ml of
distilled water. Add iodine and heat
gently with constant mixing until
iodine is dissolved. Dilute to 100 ml
with distilled water. Store in amber
glass-stoppered bottle in the dark.

6. What is the source of this
information? ( write the name of
the book) REFERENCES:
Bacteriological Analytical Manual (BAM), 8th
Edition, Revision A, 1998,
https://www.fda.gov/food/laboratory-methods-
food/bam-r40-lugols-iodine-solution
National Library Medicine

7. British Pharmacopeia
Task 2: What are the different test
solutions used in pharmacy?The main test solutions used in pharmacy are:
Standard solutions
Volumetric solutions
Reagent solutions
Buffer solutions
Indicator solutions

8. British Pharmacopeia
How are they prepared?Standard solutions – Prepared by accurately weighing a
primary standard, dissolving it in solvent (usually water), and
diluting to a fixed volume for an exact concentration.
Volumetric solutions – Prepared by dissolving or diluting a
reagent to approximate strength, then standardized against a
primary standard.
Reagent solutions – Prepared by dissolving the specified
reagent in distilled water or other solvent, at the concentration
given in the pharmacopoeia.

9. British Pharmacopeia
How are they prepared?Buffer solutions – Prepared by mixing a weak acid and its salt
or a weak base and its salt in correct ratios to maintain a
desired pH.
Indicator solutions – Prepared by dissolving the indicator in
water, alcohol, or other solvent at a defined concentration.

10. British Pharmacopeia
What is source of this information?British Pharmacopoeia (BP 2024) – Appendices on Standard
Solutions, Volumetric Solutions, and Reagents.
Indian Pharmacopoeia (IP 2022) – Appendix 3.1–3.4 on
Preparation and Standardization of Solutions and Reagents.

11. GROUP 2

12. United States Pharmacopeia Task 1:
1.What is the purity of Tab. Paracetamol I.P?
Purity of paracetamol tablets (Acetaminophen Tablets):

The purity (assay) is based on the amount of acetaminophen
present.
According to the definition of USP-NF, acetaminophen tablets
contain NLT (Not Less Than) 90.0% and NMT (Not More Than)
110.0% of the labeled amount of acetaminophen.
2. How Paracetamol Tablet is assayed?
The assay is conducted by UV spectrophotometric method.
Procedure for assay:
Methanol and water (1:3) mixture is used as the solvent.

13. Solution is prepared by dissolving tablet powder
equivalent to about 0.05 mg/mL of acetaminophen in the
solvent.
The solution is sonicated for 5 minutes, then filtered.
Measure absorbance of the solution at 243 nm using UV
spectrophotometer with 1 cm path length cell.
Use a standard acetaminophen solution prepared
similarly in methanol and water (1:3) at 0.05 mg/mL.
Calculate acetaminophen concentration in the sample
based on comparison of absorbances.
3. That is the source of this information? (write the name
of the book)
U.S Pharmacopeia National Formulary Monograph , USP
38- NF 33, Volume 2 (2015)

14. Task 2:
1.What is the assay procedure of Metformin tablet?
Assay Procedure for Metformin Tablets
Preparation:
Standard solution: 10 ug/mL USP Metformin Hydrochloride RS in
water.
Sample solution: Weigh and finely powder NLT 20 tablets - Transfer
amount equivalent to 100 mg metformin hydrochloride to a 100 mL
flask → Add 70 mL water, shake 15 min, dilute to volume → Filter →
Dilute filtrate to 100.0 mL → Further dilute to obtain 10 Mg/mL
solution.
Instrumental conditions:
• Mode: UV spectrophotometry
• Wavelength: ~232 nm (maximum absorbance)
Calculation: Compare absorbance of sample vs. standard to
determine content.
Acceptance criteria: 95.0% - 105.0% of labeled amount.

15. 2. What are the other tests use to evaluate the quality of Metformin tablet?
Identification tests
Dissolution tests
Uniformity of Dosage Units
Impurities test
Performance tests
3. What is the source of this information? (write the name of the book)
U.S Pharmacopeia National Formulary Monograph, USP 38- NF 33, Volume 3 (2015)

16. GROUP 3

17. British National
Formulary
Can ciprofloxacin be given during
pregnancy?
Task 1:
Ciprofloxacin is generally avoided during pregnancy
due to concerns about potential damage to
developing cartilage in the fetus (based on animal
studies). It should only be used if no safer alternative
is available and the benefits outweigh the risks.

18. British National
Formulary
What are the different pregnancy drug
classification?
Task 1:
Category A: Controlled studies show no risk in pregnancy.
Category B: No evidence of risk in humans; animal studies
may show risk but not confirmed in humans.
Category C: Risk cannot be ruled out; animal studies show
risk, no adequate human data.

19. British National
Formulary
What are the different pregnancy drug
classification?
Task 1:
Category D: Evidence of risk to the fetus, but benefits may
outweigh risks (e.g., in serious conditions).
Category X: Contraindicated in pregnancy; risks outweigh
any benefit.

20. British National
Formulary
What are the different pregnancy drug
classification?
Task 1:
Category Z: There are studies, recommendations, or
alerts from respective expert committees and/or
regulatory agencies for healthcare professionals
regarding the use of this drug during pregnancy.

21. British National
Formulary
What is the source of this information?
Task 1:
British National Formulary (BNF) 80 (2020)
MIMS Drug Reference; Philippines—Issue 1
(June 2022)

22. Can IV diazepam be added to a 5%
glucose drip?
Task 2:
Diazepam should not normally be mixed or
diluted with IV fluids, except with 5%
dextrose (glucose) or 0.9% sodium chloride
infusions over volumes greater than 250 mL,
and even then, the amount of diazepam
added should not exceed 20 mg.
Diazepam diluted in dextrose 5% can be stable if adequately
diluted (e.g., at least 1:40 dilution for up to 6–8 hours, or ≥1:50
dilution for up to 24 hours)

23. How do you give diazepam IV?
Task 2:
Diazepam IV should be administered by slow
intravenous injection; 5-10 mg for the initial
dose, then a subsequent dose of 5-10 mg
administered 10 minutes after the initial dose.

24. What is the source of this information?
Task 2:
National Library of Medicine
British National Formulary

25. GROUP 4

26. Task 1: What is the incidence of
cough after starting treatment with
Lisinopril as compared to Captopril?
According to Martindale’s
Extrapharmacopoeia, cough is a
recognized side effect of ACE inhibitors
such as lisinopril and captopril.
Comparative studies report that the
incidence of cough is generally higher
with captopril (5.1%) than with lisinopril
(1.6%) among patients treated for
hypertension.
Martindale’s
Extrapharmacopoeia

27. Task 1: What is the incidence of
cough after starting treatment with
Lisinopril as compared to Captopril?
According to Martindale’s
Extrapharmacopoeia, cough is a
recognized side effect of ACE inhibitors
such as lisinopril and captopril.
Comparative studies report that the
incidence of cough is generally higher
with captopril (5.1%) than with lisinopril
(1.6%) among patients treated for
hypertension.
Martindale’s
Extrapharmacopoeia

29. Martindale’s
Extrapharmacopoeia
List down drugs that are
contraindicated with the
given drug above. What
is the source of this
information? Neprilysin inhibitors (e.g., sacubitril)
Aliskiren
Angiotensin receptor blockers (ARBs)
History of angioedema or hypersensitivity to
ACE inhibitors
Hereditary or idiopathic angioedema
Pregnancy:
Lithium:
mTOR inhibitors (sirolimus, everolimus) and
injectable gold salts:
NSAIDs and diuretics:

30. Source of Information
Martindale: The Extra
Pharmacopoeia
Reynolds, J. E. F. (1993). Martindale: The Extra
Pharmacopoeia (30th ed.). London: American
Pharmaceutical Association.

31. PubMed. ACE inhibitors and cough. Discuss strategies for improving
healthcare access, particularly in underserved communities, to promote
health equity.
Medical News Today. Lisinopril (oral tablet): Side effects, interactions, and
more. Discuss strategies for improving healthcare access, particularly in
underserved communities, to promote health equity.
Reynolds, J. E. (1993). Martindale: The Extra Pharmacopoeia (30th ed.).
London: American Pharmaceutical Association. Discuss strategies for
improving healthcare access, particularly in underserved communities, to
promote health equity.
PJMHS Online. Comparison between the effects of Captopril and Lisinopril.
Discuss strategies for improving healthcare access, particularly in
underserved communities, to promote health equity.
DailyMed. LISINOPRIL. Discuss strategies for improving healthcare access,
particularly in underserved communities, to promote health equity.
GoodRx. 8 Medications That May Cause Lisinopril Interactions. Discuss
strategies for improving healthcare access, particularly in underserved
communities, to promote health equity.
PMC. Martindale: The Complete Drug Reference. Discuss strategies for
improving healthcare access, particularly in underserved communities, to
promote health equity.
NCBI Bookshelf. Lisinopril. Discuss strategies for improving healthcare
access, particularly in underserved communities, to promote health equity. References:

32. Martindale’s
extrapharmacopoeia
Task 2: Classify cephalosporins
according to its generation. What
is the source of this information?

33. First generation: Good activity against Gram-
positive cocci, limited Gram-negative coverage
Second generation: Improved Gram-negative
coverage, retains Gram-positive activity
Third generation: Broader Gram-negative
spectrum, includes some anti-Pseudomonal
agents, some cross the blood-brain barrier
Fourth generation: Enhanced stability against
β-lactamases, broad Gram-negative coverage
plus increased Gram-positive potency
Fifth generation: Active against MRSA and
some Gram-negative organisms

34. Source of Information
Martindale: The Extra
Pharmacopoeia
Reynolds, J. E. F. (1993). Martindale: The Extra
Pharmacopoeia (30th ed.). London: American
Pharmaceutical Association.

35. PubMed. ACE inhibitors and cough. Discuss strategies for improving
healthcare access, particularly in underserved communities, to promote
health equity.
Medical News Today. Lisinopril (oral tablet): Side effects, interactions, and
more. Discuss strategies for improving healthcare access, particularly in
underserved communities, to promote health equity.
Reynolds, J. E. (1993). Martindale: The Extra Pharmacopoeia (30th ed.).
London: American Pharmaceutical Association. Discuss strategies for
improving healthcare access, particularly in underserved communities, to
promote health equity.
PJMHS Online. Comparison between the effects of Captopril and Lisinopril.
Discuss strategies for improving healthcare access, particularly in
underserved communities, to promote health equity.
DailyMed. LISINOPRIL. Discuss strategies for improving healthcare access,
particularly in underserved communities, to promote health equity.
GoodRx. 8 Medications That May Cause Lisinopril Interactions. Discuss
strategies for improving healthcare access, particularly in underserved
communities, to promote health equity.
PMC. Martindale: The Complete Drug Reference. Discuss strategies for
improving healthcare access, particularly in underserved communities, to
promote health equity.
NCBI Bookshelf. Lisinopril. Discuss strategies for improving healthcare
access, particularly in underserved communities, to promote health equity. References:

36. In conclusion, this exercise highlights the
importance of utilizing unbiased and credible
sources of drug information such as
pharmacopeias, formularies, and authoritative
references to ensure accuracy in clinical
practice. By learning to select the most
appropriate source depending on the
information required, students strengthen their
ability to make evidence-based decisions in
healthcare. Moreover, understanding both the
merits and limitations of each source fosters
critical thinking and responsible use of drug
references in real-world applications.
CONCLUSION:

37. THANK
YOU!