Dissolution

Dissolution Test General

Aim: In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release data for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage (OSD) forms, and drug formulation & development, i.e., to predict in vivo drug release pattern & profiles.

There are three typical situations where dissolution testing plays a vital role:

1. Formulation and optimization Decisions: Both the product formulation and the manufacturing process are optimized based on reaching particular dissolution targets during product development for products where dissolve performance is a critical quality attribute.

• Equivalence Decisions: Similarity of in vitro dissolution profiles between the reference product and its generic or modified version is one of the major criteria for regulatory approval decisions during generic product development, as well as when executing post-approval processes or formulation changes.

• Product Compliance and Release Decisions: Dissolution results are frequently one of the variables used to make product release decisions during normal manufacturing.

Dissolution Apparatus Type:

Type	Indian Pharmacopoeia (I.P)	USP	British Pharmacopoeia (B.P)	European Pharmacopoeia(Ph. Eur./ E.P)	Japanese Pharmacopoeia (J.P)
Apparatus I	Paddle	Basket	Basket	Basket	Basket
Apparatus II	Basket	Paddle	Paddle	Paddle	Paddle
Apparatus III	NA	Reciprocating cylinder	Flow-through cell	Reciprocating cylinder	Flow-through cell
Apparatus IV	NA	Flow-through cell	NA	Flow-through cell	NA
Apparatus V	NA	Paddle over disk	NA	NA	NA
Apparatus VI	NA	Cylinder	NA	NA	NA
Apparatus VII	NA	Reciprocating disk	NA	NA	NA
Apparatus VIII	NA	(Non-USP-NF)	NA	NA	NA
Apparatus IX	NA	(Non-USP-NF)	NA	NA	NA

USP Type Dissolution Apparatus & Use:

Type	Name	Used For
Apparatus I	Basket	Tablets
Apparatus II	Paddle	Tablets. capsules modified drug products
Apparatus III	Reciprocating cylinder	Extended-release drug products.
Apparatus IV	Flow-through cell	Drug products containing low-water-soluble drug
Apparatus V	Paddle over disk	Transdermal drug products.
Apparatus VI	Cylinder	Transdermal drug products.
Apparatus VII	Reciprocating disk	Extended-release drug products
Apparatus VIII	(Non-USP-NF)	Extended-release drug products (beads).
Apparatus IX	(Non-USP-NF)	Ointments, creams, transdermal drug products.
Apparatus I	Rotating basket	Tablets
Apparatus II	Paddle	Tablets. capsules modified drug products
Apparatus III	Reciprocating cylinder	Extended-release drug products.

Type of Sinkers:

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