Worst Case Products Tablets Capsules and PPS Matrix

Your Company's L

Your Company's L

Your Company's N

Your Company's N

In the previous chapter, we observed that equipment trains are used for manufacturing solid dosage forms, based on the respective processes. The objective of this protocol is to present an overview and the focus of discussion is to correlate the product's ingredients and the equipment train to select the worst-case product for each piece of equipment. It is always better to categorize and subcategorize the products in terms of the difference in processes to make the selection of worst-case products easy and simple: for example, products matrices based on coated or uncoated tablets or a matrix based on wet granulation or dry granulation products. Even if the same equipment is being used, there is no harm in selecting more than one worst-case product for one equipment train due to the difference in processes as explained above. The worst-case products for tablets, capsules, and PPS are presented in the following matrices.

19.1 Worst-Case Products (Tablets)

Products

Justification for Worst Case

Ciprofloxacin 500 tablet Six ingredients insoluble in water

Ciprofloxacin HCl (7) Kolidone (7) Primogel (7) Aerocil 200 (7) Magnesium stearate (7) Avicel PH-102 (7)

Ketotifen 1.0 mg tablets Therapeutic dose 1.0 mg Diclofenac 50 mg tablet LD50 150 mg/kg oral rat B-complex tablets Largest batch size (682 kg)

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

19.1.1 For Coating Machines Only

Products

Justification for Worst Case

Ciprofloxacin 500 tablet Cetirizine 10 mg tablet Diclofenac 50 mg tablet B-complex tablets

Six ingredients insoluble in water Less therapeutic dosage (10.0 mg) Toxicity. LD^ 150 mg/kg oral rat Largest batch size (682 kg)

19.1.2 Sugar-Coated Products (for Conventional Coating Pans)

Products

Justification for Worst Case

Sennoside 12 mg tablets

Bisacodyl 5 mg tablets Ibuprofen 200 mg Ibuprofen 200 mg

Three ingredients insoluble in water Avicel (7)

Magnesium stearate (7) Aerocil 200 (7)

Minimum therapeutic dose (5 mg) Largest batch size (495 kg) Toxicity. LD^ 636 mg/kg oral rat

After having done the selection of worst-case products for tablets based on product grouping and equipment train matrices, the same exercise will be carried out for all other products from various dosage forms, as shown in the following tables.

19.2 Worst-Case Products (Capsules) 19.2.1 For Encapsulator A

Products

Justification for Worst Case

Oxytetracycline

Doxycycline 100 mg capsule

Three ingredients insoluble in water Aerocil 200 (7) Magnesium stearate (7) Talc fine (7)

Maximum potency (100 mg)

Indomethacin 25 mg capsule Largest batch size (1,000,000)

Your Company's Logo

Your Company's Logo

Your Company's Name

Your Company's Name

19.2.2 For Encapsulator B

Products

Justification for Worst Case

Lansoprazole 30 mg capsule Erythromycin 250 mg capsule Folic acid/iron capsule

Maximum potency (30 mg) Insoluble in water (7) Largest batch size (1,000,000)

19.3 Worst-Case Products (Granules)

Products Justification for Worst Case

Erythromycin 200 mg/5 mL Two ingredients insoluble in water

Erythromycin (7) Simethicone (7)

Azithromycin 200 mg Second largest batch size (200.8 kg)

CLV-20

Was this article helpful?

0 0
Healthy Chemistry For Optimal Health

Healthy Chemistry For Optimal Health

Thousands Have Used Chemicals To Improve Their Medical Condition. This Book Is one Of The Most Valuable Resources In The World When It Comes To Chemicals. Not All Chemicals Are Harmful For Your Body – Find Out Those That Helps To Maintain Your Health.

Get My Free Ebook


Post a comment