DISSOLUTION

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Slide 1: 

HEMANT VINEETH BIOPHARMACEUTICS DISSOLUTION APPARATUS PRESENTED BY:

WHAT IS MEANT BY “DISSOLUTION” ?. : 

WHAT IS MEANT BY “DISSOLUTION” ?. A process in which a solid substance is solubilised in a given solvent that is mass transfer from solid surface to liquid phase . It is a process by which drug released from solid dosage form and immediately goes into molecular solution .

Why do we study dissolution ? : 

Why do we study dissolution ? Dissolution Absorption Drug in blood and body fluids deaggregation

Theories on dissolution : : 

Theories on dissolution : Diffusion layer model or film theory. danckwert’s model or surface renewal theory. Interfacial barrier model.

Diffusion layer model : : 

Diffusion layer model : 1.Simplest and most common . 2.Absence of reactive/chemical forces dissolution involues two steps i.formation of stragnated film/diffusion layer . ii.diffusion-slower,rate determining step. Noyes and whitney equation: Dc/dt=DAKw/o(cs-cb)/vh

Danckwert’s model: : 

Danckwert’s model: 1. Did not approve existence of stragnated layer. 2. Turblance in dissolution medium exists at solid- liquid interface. 3. Pocket of eddys current absorb the solute by diffusion. Vdc/dt=dm/dt=A(cs-cb).√¥D

Interfacial barrier model: : 

Interfacial barrier model: 1.Assumption of previous models. 2.Intermediate conc. exist at the interface as a result of solvation mechanism it is function of solubility rather than diffusion.

Factors affecting & processes influenced by Dissolution: : 

Factors affecting & processes influenced by Dissolution: TEMPERATURE PH STATE OF DRUG ABSORPTION DISSOLUTION BIOAVAILABILITY

Slide 9: 

DISINTEGRATION DISSOLUTION PERMEATION BODY FLUIDS ABSORPTION

SOLUBILITY RDS FOR ABSORPTION DISSOLUTION RDS FOR ABSORPTION : 

SOLUBILITY RDS FOR ABSORPTION DISSOLUTION RDS FOR ABSORPTION ?

1.CISAPRIDE-low solubility , high dissolutionlow dosage . 2.salt form of drugs –in bulk solution form fine particles. ↓ low soluble , high dissolution because of high effective surface area 3. aspirin –more soluble ,more hydrolytic stability so less base absorption. : 

1.CISAPRIDE-low solubility , high dissolutionlow dosage . 2.salt form of drugs –in bulk solution form fine particles. ↓ low soluble , high dissolution because of high effective surface area 3. aspirin –more soluble ,more hydrolytic stability so less base absorption.

Goals of predictive dissolution test: : 

Goals of predictive dissolution test: To accessing therapeutic efficacy. Monitoring batch to batch consistency . High cost of in vitro dissolution test. Assessment of bioequivalence.

Based on presence of sink or non sink conditions dissolution apparatus are classified as : : 

Based on presence of sink or non sink conditions dissolution apparatus are classified as : 1.Closed compartment apparatus 2.Open compartment apparatus

TYPES OF DISSOLUTION APPARATUS : 

USP dissolution apparatus (official): 1. Apparatus 1:Basket type 2. Apparatus 2:Paddle type 3. Apparatus 3:Reciprocating cylinder 4. Apparatus 4:Flow through cell 5. Apparatus 5:Paddle over disc 6. Apparatus 6:Rotating cylinder 7. Apparatus 7:Reciprocating disc USP dissolution apparatus (non-official): Rotating bottle method. Diffusion cell. Peristalisis method. Intrinsic dissolution method. TYPES OF DISSOLUTION APPARATUS

IP dissolution apparatus :Apparatus 1:Paddle typeApparatus 2:Basket type : 

IP dissolution apparatus :Apparatus 1:Paddle typeApparatus 2:Basket type BP dissolution apparatus : Apparatus 1:basket type Apparatus 2:paddle type Apparatus 3:flow through cell

USP Apparatus 1 :Basket type Design:a)Vessel :-Made up of borosilicate glass -Semi hemispherical bottom -Capacity 1000ml b)Shaft : -Stainless steel 316 -Rotates smoothly without significance wooble c)Basket :- Stainless steel 316 -Gold coatings up to 0.0001 inch d)Waterbath : Maintained at 37±0.5⁰c : 

USP Apparatus 1 :Basket type Design:a)Vessel :-Made up of borosilicate glass -Semi hemispherical bottom -Capacity 1000ml b)Shaft : -Stainless steel 316 -Rotates smoothly without significance wooble c)Basket :- Stainless steel 316 -Gold coatings up to 0.0001 inch d)Waterbath : Maintained at 37±0.5⁰c Use: Capsules,tablets,delayed release, suppositories,floating dosage forms

APPARATUS 2:PADDLE TYPE: : 

APPARATUS 2:PADDLE TYPE: Design: 1.Vessel: 2.Shaft:The blade passes through shaft so that bottom of blade fuses with bottom of shaft . 3.Stirring elements :- Made of tefflon -For laboratory purpose -Stainless steel 316 4.Waterbath :Maintain at 37±0.5⁰c 5.Sinkers:Platinum wire used to prevent capsule /tablet from floating

Slide 19: 

Paddle type:

APPARATUS 3 :RECEPROCATING CYLINDER : 

APPARATUS 3 :RECEPROCATING CYLINDER Design: 1.Vessel:Cylindrical flat bottom glass vessel 2.Agitation type: -Reciprocating -Generally 5-35 rpm 3.Volume of dissolution fluids :200-250 ml 4.Water bath: Maintain at 37±0.5⁰c Use : Extended release

APPARATUS 4:FLOW THROUGH CELL : 

APPARATUS 4:FLOW THROUGH CELL Design: 1.Reservoir:For dissolution medium 2.Pump:-Forces dissolution medium through cell -holding a sample -Flow rate 10-100 ml/min -Laminar flow is maintained -peristalic/centrifugal pumps are not recommended 3.Water bath: Maintain at 37±0.5⁰c Major advantage : -to maintain sink conditions -Large volume dissolution media is used.

APPARATUS 5:PADDLE OVER DISK : 

APPARATUS 5:PADDLE OVER DISK Design 1.Vessel: 2.Shaft: 3.Stirring elements: 4.Sample holder : -Disk assembly that hold the product in such a way that release surface is parallel with paddle. -Paddle is directly attached over disk assembly . -Samples are drawn away b/w the surface of medium and top of paddle blade. 5.Volume:900ml 6.Temperature:32 ⁰c

Slide 25: 

Paddle over disk apparatus Text Here

APPARATUS 6:ROTATING CYLINDER : 

APPARATUS 6:ROTATING CYLINDER Design: 1.Vessel:In place of basket cylinder is used. 2.Cylinder:Stainless steel 316. 3.Sample:-Mounted to cuprophan (inner porous cellulosic material) an entire system is adhere to cylinder. -Dosage unit is place in cylinder and released from outside 4.waterbath: Maintain at 32±0.5⁰c Use : transdermal patches cannot be cut into small size.

Slide 27: 

2

APPARATUS 7:RECIPROCATING DISK : 

APPARATUS 7:RECIPROCATING DISK 1.Vessel:-Flat bottom cylindrical vessel -Volume of dissolution medium 50-200ml 2.Shaft: 3.Sample:Placed on disk shaped holders. 4.Agitation:-Reciprocation -Reciprocating frequency 30 cycles/min. 5.Waterbath: Maintain at 32±0.5⁰c Use : transdermal patches

References: : 

References: United states pharmacopeia Indian pharmacopeia British pharmacopeia Pharmaceutical dissolution testing –jennifer dressman,jennifer kramer

Trust yourself : 

Trust yourself Guided by: lecturers Naga aparna Kethan Deepthi

Slide 32: 

Thank You