Tooth Powder - Pharmacological Actions & Uses

Pharmacological Actions of Ingredients

Therapeutic Uses

• The major use of tooth powder is to clean the teeth.

Commercial Example Shown: "Super Rakshak" Tooth Powder

• Calcium carbonate
• Flavor
• Sodium carbonate
• Saccharin
• Sodium lauryl sulfate

Exercises (as shown in the book)

1. Identify the drug formulation displayed at the various stations.
2. Demonstrate to the subject the proper usage of the drug formulation in a simulated environment.

• Recognize commercially available pharmaceutical formulations
• Understand the role of each constituent
• Demonstrate proper usage to patients

Exercise Answers (Short, for the boxes)

Box 1: Identify the drug formulation displayed at the various stations.

• Type: Topical dental preparation
• Contains: Calcium carbonate, Sodium bicarbonate, Thymol, Saccharin, Hard soap
• Use: Cleaning teeth, preventing caries, removing stains

Box 2: Demonstrate to subject the proper usage of drug formulation in simulated environment.

1. Take a small amount of tooth powder on a wet toothbrush
2. Brush teeth gently in circular motion for 2 minutes
3. Cover all surfaces - front, back, and chewing surfaces
4. Rinse mouth thoroughly with water
5. Use twice daily - morning and after meals

Note: These are the short, box-fill answers suitable for your practical record/answer sheet.

Objective Answers (Short, for the dotted lines)

1. Comment on the given formulations keeping in view the label information:

• Check drug name, dose, batch no., expiry date, manufacturer details
• Verify constituents match standard formulation
• Check for any excipients that may cause adverse effects
• Confirm storage conditions mentioned on label are appropriate
• Ensure no recall or withdrawal notice for that batch

2. Suggest ways to improve the formulation presentation:

• Use clear, readable font on label
• Mention all ingredients with exact quantities
• Add proper storage instructions (temp, light, humidity)
• Include patient-friendly usage directions
• Add warning labels for adverse effects/contraindications
• Use tamper-proof, child-resistant packaging
• Mention overdose management on label or insert

Exercise Answers (TDM)

Q1. When samples should be collected:

Q2. Theophylline 300 mg - level 7 mg/L (Normal: 5-15 µg/mL)

• Level is within normal range
• Symptoms (tremor, anxiety, palpitations) may be due to individual sensitivity
• Advice: Reduce dose slightly or switch to SR formulation; monitor levels; reassure patient

Q3. Phenytoin level 26 µg/mL (Normal: 10-20 µg/mL)

• Level is above normal (toxic range)
• Sensorium disturbance = sign of phenytoin toxicity
• Advice: Stop/reduce dose immediately; recheck levels after 48 hrs; once level normalizes, restart at lower maintenance dose (150-200 mg/day); monitor clinically

Q17. Gliclazide + Chlorothiazide

Q18. Glibenclamide + Propranolol

Q19. Nitrates + Tadalafil

Q20. Carbamazepine + Grapefruit Juice (GFJ)

Q1. Oral Contraceptive Pills – Counselling

• You will be on a contraceptive pill to prevent pregnancy
• Start on 5th day of menstrual cycle
• Take 1 pill daily at same time each night
• Start new pack immediately after finishing – no gap
• If 1 pill missed – take it next day
• If 2+ pills missed – use additional contraception (condom)
• Use extra protection in first cycle
• May have withdrawal bleeding (normal) between cycles
• Side effects: nausea, breast tenderness, breakthrough bleeding
• Come for follow-up as scheduled

Q2. Anti-TB Kit (4 drugs) – Counselling (35-year female)

• Kit contains: Isoniazid, Rifampicin, Pyrazinamide, Ethambutol
• Take all 4 tablets daily, empty stomach
• Never skip – incomplete treatment causes drug resistance
• Course duration: 6 months minimum
• Rifampicin turns urine/sweat orange-red – normal, don't panic
• Avoid alcohol completely
• Side effects: nausea, liver problems – report yellowing of eyes immediately
• Regular follow-up and sputum tests needed
• If planning pregnancy – inform doctor (some drugs harmful to fetus)
• Do not stop even if feeling better

Exercise: Drug Treatment of Organophosphorus Poisoning

• Features: miosis, excessive secretions, bradycardia, muscle twitching, seizures (SLUDGE symptoms)

1. Remove from exposure – remove clothes, wash skin with soap and water
2. Secure airway – oxygen, suction secretions
3. Atropine – 2–4 mg IV, repeat every 5–10 min until secretions dry (atropinization)
4. Pralidoxime (PAM) – 1–2 g IV slowly (within 24 hrs of poisoning) to reactivate cholinesterase
5. Diazepam – for seizures (5–10 mg IV)
6. Supportive care – IV fluids, monitor vitals, Foley catheter
7. Gastric lavage – if ingested and airway secured

• Dry secretions, heart rate >80/min, pupils dilated = adequate atropinization

Ex 1: Research Plan using ICMR Guidelines

1. Title – Short, clear research topic
2. Introduction – Background and rationale
3. Objectives – Primary and secondary aims
4. Study design – Observational/experimental
5. Study population – Inclusion/exclusion criteria
6. Sample size – Calculated as per ICMR norms
7. Methodology – Data collection method
8. Ethical approval – IEC clearance required
9. Budget – Within ICMR STS grant limits (₹10,000–50,000)
10. Timeline – 3–6 months
11. Expected outcome – Results and publication plan

Ex 2: Steps in EBM (Evidence Based Medicine)

1. Ask – Formulate clinical question (PICO format)
2. Acquire – Search evidence (PubMed, Cochrane)
3. Appraise – Critically evaluate evidence quality
4. Apply – Apply best evidence to patient
5. Assess – Evaluate outcome after applying

Ex 3: EBM Applied to TDM

• Ask: What is the optimal drug level for this patient?
• Acquire: Search RCTs/guidelines for therapeutic range
• Appraise: Check validity of TDM studies for that drug
• Apply: Adjust dose based on measured plasma level + evidence
• Assess: Monitor clinical response and toxicity after dose change

PH 10.11.1 – PANDEMIC MODULE

Identify and Apply Drug Regulations, Principles, Acts and Legal Aspects Related to Drug Discovery and Clinical Use

INTRODUCTION

KEY REGULATORY ACTS IN INDIA

SPECIAL PANDEMIC PROVISIONS

• Emergency Use Authorization (EUA): Fast-track approval for vaccines/drugs during public health emergency (e.g., Covaxin, Covishield in COVID-19)
• Accelerated Approval: Phase 3 trials allowed to overlap with Phase 2
• Waiver of local trials: For drugs approved by recognized foreign agencies (US FDA, EMA)
• Compassionate Use: Unapproved drugs given to critically ill patients with no other options (e.g., Remdesivir in COVID-19)

DRUG DISCOVERY PROCESS (Brief)

1. Drug discovery → 2. Preclinical trials → 3. Phase I, II, III Clinical trials → 4. Regulatory submission → 5. Approval → 6. Post-marketing surveillance (Phase IV)

LEGAL ASPECTS

• Schedule H / H1: Drugs sold only on prescription
• Schedule X: Narcotic/psychotropic drugs – strict record keeping
• GMP (Good Manufacturing Practice): Mandatory for all manufacturers
• Patent Law (Patents Act, 1970): Compulsory licensing allowed during national emergency to produce generic versions of patented drugs (e.g., generic antivirals)
• Pharmacovigilance: Mandatory reporting of Adverse Drug Reactions (ADR) to PvPI (Pharmacovigilance Programme of India)

PRINCIPLES APPLIED DURING PANDEMIC

• Beneficence – maximize benefit to population
• Non-maleficence – minimize harm; rigorous safety monitoring
• Justice – equitable drug distribution
• Autonomy – informed consent even in emergency trials

CONCLUSION

PH 10.11.1 – PANDEMIC MODULE

Key Acts

• Drugs & Cosmetics Act, 1940 – governs manufacture, sale, import of drugs
• New Drugs & Clinical Trials Rules, 2019 – regulates clinical trials
• Patents Act, 1970 – allows compulsory licensing during national emergency
• CDSCO – national drug regulatory authority of India

Pandemic Special Provisions

• Emergency Use Authorization (EUA) – fast-track approval (e.g., Covaxin, Covishield)
• Compassionate Use – unapproved drugs for critically ill (e.g., Remdesivir)
• Accelerated Approval – Phase II & III trials overlap
• Compulsory Licensing – generic production of patented drugs allowed

Drug Discovery Steps

Legal Aspects

• Schedule H/H1 – prescription-only drugs
• GMP – mandatory for manufacturers
• Pharmacovigilance – ADR reporting to PvPI mandatory

Ethical Principles