Manufacturing of Capsules
In capsule formulation development and during manufacturing of capsule dosage forms, a number of standard and regulatory requirements are met before they are approved for consumption and marketing. Below are the compendial standards and regulatory requirements for capsules.
The manufacture of Capsule is a complex multi-stage process whereby Plant Manager ensures that the correct amount of drug substance in the right form is delivered at the appropriate time, at the proper rate and in the desired location with its chemical integrity protected to that point. As a result, they are subjected to pre-treatment either alone or in combination with suitable excipients to form free-flowing granules that lend themselves to Capsules.
Among solid dosage forms, the capsule is second only to the compressed tablet in frequency of utilization for drug delivery, and the hard shell capsule continues to be the more frequently used form. Because hard shell capsules are often perceived as “simpler” than other oral dosage forms, they are frequently the first dosage form administered to humans and sometimes the final marketed dosage form.
EVALUATION/ QUALITY CONTROL OF RAW MATERIALS USED IN THE MANUFACTURE OF CAPSULES
Quality control of raw materials (APIs and excipients) is one of the main tasks of the quality control unit in any drug manufacturing industry. Raw materials described in monograph of relevant Pharmacopoeia must undergo the necessary tests as stated in the monograph. It is often sufficient if identification testing is conducted on the individual packages/containers and content and purity determination in mixed samples.
Every manufacturer has the opportunity to carry out further testing if they deem it necessary for guaranteeing a smooth-running production process or a very high-quality product. Starting materials are released only after their quality are established or judged as satisfactory. Raw materials that fail the quality control test are rejected and returned to the supplier.
Any risks that may emanate from starting materials of inappropriate quality must be avoided to prevent product failure and to ensure a consistent level of quality, as well as safety in consumer and industrial products
Image Gallery
Capsules Manfacturing
Approved Form-7 Generic Formulations that we Manufactured
| Product Name | Generic NAME |
|---|---|
| Salbion's Carnet Capsule (Neutra) | Each capsule (500 mg) contains: L - Carnitine ……………………….. 500 mg |
| Ravoglobin Capsule (Neutra) | Each capsule (550 mg) contains: Vitamin - C …………….................. 60 mg Vitamin - B1 ……………………...... 1.4 mg Vitamin - B2 …………………........ 1.6 mg Vitamin - B3 ……………………….... 18 mg Vitamin - B6 ……………………...... 2 mg Folic Acid ………………………... 200 mcg Vitamin - B12 ……………………….. 1 mcg Pantothenic Acid ………………........ 6 mg Iron Sulphate………………....... 14 mg Zinc Sulphate ……………………..... 2.5 mg Manganese ……………………..... 0.5 mg |
| Terris-T Capsule (Neutra) | Each capsule (550 mg) contains: Tocopherol …………………………..….… 100 mg Zinc Oxide …………………………………. 12 mg Selenium …………..………………………. 33 µg Tribulus Terrestris ………………………. 250 mg |
| Mecocid Capsule (Neutra) | Each capsule ( 550 mg) contains: Mecobalamin …………………………... 1500 mcg Alpha Lipoic acid ………………………. 100 mg Folic acid …………..…………………….. 0.2 mg |
| Peprica Capsule (Herbal) | Each capsule (550 mg) contains: Peppermint ……………………………… 500 mg |
| Crantik Plus Capsule (Neutra) | Each capsule ( 550 mg ) contains: Total Probiotic Blend ….. 5 × 108 Viable Cells Composed of following strains: Lactobacillus Reuteri (Codex) Lactobacillus Rhamnosus (Codex) Cranberry Extract ………………………… 50 mg |
| Syvita Capsule (Neutra) | Each capsule ( 550 mg ) contains: Ginkgo biloba…………………….. 20 mg Vitamin - E………………………… 2 mg Panax Ginseng ……….............. 50 mg L – Arginine ……………….…….. 50 mg Zinc Oxide……………………….… 10 mg Withania Somnifera …….......... 50 mg Selenium ………………………....32 mcg Eurycoma Longifolia…………... 50 mg Tribulus Terristris ………....... 250 mg |
Capsules
