Oral Route Of Administration Biology Essay

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There is different type of route of administrations oral route, parenteral route, sublingual route, rectal route, vaginal route, nasal route, inhalation, cutaneous route, transdermal route.

The oral route of administration most preferable route of administration including solutions, suspensions, emulsions, pastes, and tablets, capsules, powders, granules, premix. Tablets are solid dosage forms made with suitable API and excipients. Tablet usually compressed with a number of adjuncts including diluents, binders, disintegrants, antiadherent, colorants and flavouring. After compression tablets may be coated with various materials. Tablets and capsules are popular dosage form due to ease of self administration, pain avoidance, versatility, patient compliance and easy manufacturing. Tablets may vary in size, shape, weight and in other as depending on their intended use and method of manufacture.

With Active ingredient number of excipient added for different purposes. Mostly filler, disintegrant, binder, glidant, lubricant, sorbent, flavour, and colourant added as excipients. Tablet is manufactured with direct compression, wet granulation or dry granulation. Direct compression is simplest method for manufacturing. To improve flow properties of mixture or mechanical strength granulation process require. Wet granulation is used to improve flow, compressibility, bio-availability, homogeneity, electrostatic properties, and stability of solid dosage forms.

There are different types of tablets - BP2009 kasture gbook

Uncoated tablets include normal compressed tablets which contain API and excipients. Other one is multiply tablets has more than one layer of different material to staged drug release, chemical-physical incompatibility and for different appearance.

Coated tablets: compressed tablets may be coated with mixtures of different substances.

Sugar coated tablets coated with sugar layer to protect the inserted drug from the environment and mask bitter taste of drug. Sugar coating process is time consuming and required expertise during process.

Film coated tablets are coated with a thin layer of polymer which give better appearance as like film. This process has advantage over sugar coating. Tablet can be designed at which dissolve the desired location by this process. Film coating protects from environmental conditions.

Enteric coated tablets are coated with special material to release in to intestine and prevent stomach effect on tablet for enhance drug absorption and reduce gastric irritation. Enteric coating is beneficial over drug which irritating in stomach or which destroys at low pH.

Effervescent tablets are compressed tablets contain drug and carbonates or hydrogen carbonates which release gas in contact with water. Effervescent tablets are dissolved in water before administration.

Buccal and sublingual tablets are flat oval shaped tablets to be placed in the buccal pouch or beneath the tongue for absorption through oral mucosa. Buccal tablets are designed to release slowly while sublingual tablets are dissolving promptly.

Chewable tablets are chewed or allowed to dissolve in the mouth contain flavouring agent for taste. Chewable tablets are prepared by using mannitol, sorbitol, or sucrose as binders and fillers, and colors and flavours to enhance their appearance and taste. Normally antacid tablets are more desirable because antacid require large dose so it may give swallowing problem.

Molded tablet are prepared by molding instead of compression. Tablet triturates are small molded tablet they are very soft and designed to rapid dissolution.

Mouth dissolving or disintegrating tablets normally dissolved in the mouth within 1 minute.

Extended release tablets also called as controlled release tablets. This type of tablet release slowly so that it absorbed by body over a time period from single dose. So its produce continuous therapeutically effect. Continues and consistent release of medicine is the main advantage of extended release tablets.

Vaginal tablets are uncoated, pear or ovoid tablet inserted into vagina for local effect. They normally contain antibacterial or antiseptic drugs.

Dental cones are used after a tooth extraction to be place in the empty pouch which normally contain antibacterial drug, coagulant or astringent to avoid infection and decrease bleeding. Dental cones released slowly.

Implants: Implants also referred as a depot tablets. These tablets are inserted into subcutaneously for long period and constant release of drug. Main demerits are it requires surgical technique for administration and discontinue as well. There may be chance of tissue toxicity.

Mouth dissolving tablets:

Tablets dosage forms are not suitable for poor solubility drugs, drugs that needed onset of action or have serious side effects. Drug with bitter taste, sensitive to oxygen or atmospheric moisture are not suitable for direct compression it may require encapsulation. salbuta

The oral route of administration especially Swallowing of formal tablet and capsule is unmanageable in paediatric, elderly patients and dysphasia patients associated with stroke, Parkinson's disease, AIDS, thyroidectomy and other neurological disorders including cerebral palsy 2-5 shukla.

An estimated 35% of the general population, and an additional 30-40% of elderly institutionalized patients and 18-22% of all persons in long-term care facilities, suffer from dysphagia. md shrikonda

Liquid medicaments (suspension and emulsion) are packed in multidose container; therefore achievement of uniformity in the content of each dose may be difficult. Possibility of breakage, leakage during transport and preservative are other problems. Buccal and sublingual formation may cause irritation to oral mucosa, so patients refused to use such medications.

Administration of drug would be affected by some physiological effects of gastrointestinal system and first pass metabolism by hepatic enzymes thus clinical effect of drug may be reduce with tablet and capsule and other oral dosage form.

Cost of products due to sterile environment and painful administration is main factor as parenteral formulations are most costly and discomfort. Mouth dissolving tablets are perfect over all this type of problems.

Mouth dissolving tablets are also known by different name as ordispersible tablets, rapid disintegrating tablet, fast dissolving tablet, rapimelts, porous tablets and etc. The European Pharmacopoeia defines the term "orodisperse" as a tablet that can be placed in the mouth where it disperses rapidly before swallowing [9]shukla Fast dissolving tablets are designed to dissolve within few seconds in contact with saliva. Other excipients are added to increase the disintegration of tablets into oral cavity in three minutes and these tablets are termed fast-disintegrating tablets.

Mouth dissolving tablet took simply by placing them on the tongue. Tablets are designed to disintegrate or dissolve quickly on contact with saliva, thus no need of water for swallow or no need to chew tablet. Less frequently, they are designed to be absorbed through the buccal and oesophageal mucosa as the saliva passes into the stomach. This leads to increase the bioavailability by avoiding first pass liver metabolism 3 salbuta. This type of drug delivery is becoming popular day by day due to its numerous advantages. Maximizing the porous structure of the tablet matrix and introducing an adequate disintegrating agent and use of highly water soluble excipients make it to dissolve rapidly.

Ideal Mouth dissolving tablet should - royal20

Ease to administration to paediatric, mental ill or elderly who refuse to swallow a tablet.

Not require water to swallow.

Dissolve or disintegrate within matter of second.

Be compatible with taste masking.

Have mouth pleasing taste.

Leave minimum or no residue after administration in mouth.

Have low sensivity to environmental condition as humidity and temperature.

Not be either too hard or fragile.

Allow high drug loading.

Convenience of administration and accurate dosing as compared to liquid dosage form.

Be adaptable and comfortable to existing processing and packaging machinery.

Allow using suitable processing and packaging at low cost for manufacturer.

Advantages

Rapid dissolution and absorption which may produce onset of action.

Masked taste of API helps to change the primary view of ''bitter tablet'' especially for children

Pre-gastric absorption can result in improved bioavailability and low amount of dosage allow less unwanted side effects..

No need of water to swallow, which highly attract to travelling patient. It is good marketing point to profit for pharmaceutical company as well.

Limitations 232 Ansel

If something wrong in formula the tablet may leave unpleasant taste and /or grittiness.

Drug with high loading dosage create problem in formulation.

Careful handling require during manufacturing due to insufficient mechanical strength.

Challenges in the formulation of oral disintegrating tablets sudhir

Mechanical strength and disintegration time: Mechanical strength is primary challenge while maintain disintegration time of MDTs. Fragile tablet will have chance of breaking during transport or handling by the patients while hard tablet don't exists low disintegrating time.

Taste masking: MDTs are completely dissolved in mouth so masking bitter taste of API is important to avoid patient compliance and acceptance for dosage from.

Mouth feel: Particle after dissolution of MDT should be as small as possible. This problem can be solved by addition of flavours and cooling agents as like menthol improve the mouth feel.

Sensitivity to environmental conditions: As most of materials used in mouth dissolving tablet are intended to dissolve in minimum quantity of water, MDT should exhibit low sensitivity to environment conditions.

Selection of drug 11 chandan

The ideal drug used for mouth dissolving tablet should not bitter in taste, have enough stability in water and saliva, minimum dose lower than 20mg, nonionised at the oral cavity pH and small to moderate molecular weight. While short halftime and repeated dosing type of drug is not suitable for orally disintegrating tablets. Physical properties of the active ingredient are also helpful factor to consider tablet design.

Ingredients to be used for Fast dissolving tablets:

Active pharmaceutical ingredient and different excipients used in the FDDTs should allow quick release of the drug, resulting in faster dissolution. Understanding chemistry of these excipients is important to prevent interaction with the API. Cost of these excipients is also important for formulators. The temperature of the excipient should be preferably around 30-35C for faster melting properties. Smaller particle size of the excipients gives a better smooth surface which improve physical properties and better mouth feel.

Many additives will also show their secondary functions as like some diluents or fillers may help to tablet dissolution and most effective lubricants are water repellent by their nature, which may delay both disintegration and dissolution.

Disintegrants are also essential to ensure quick disintegration and high dissolution rates. 14 mdkaur. Disintegrants are agents which increasing surface area and promoting a more rapid release of the drug substance for the breakup of the tablet into smaller fragments in aqueous environment. Swelling of particle, porosity, wicking, deformation and severe mechanism of action suggested for disintegrants. However two main processes involved in during disintegration. Aulton

1. Disintegrants that facilitate water uptake:

This type of disintegrants helps to transport of liquids into the pores of the tablet which leads to break into fragments. One of the substances are surface active agents that increase the wetting of the solid and the penetration of the liquid into the pores of the tablet other are working by using capillary forces.

2. Disintegrants that will rupture the tablet: swelling of the disintegrant particle causes rupturing of tablet.

Fast dissolving requires quick absorption of water in to the centre of tablets. Thus, Tablets have open pore structures inside is very important for making fast dissolving tablets.

To get sufficient effect of disintegrant, tablet surface must be comfortable to wetting. High proportion of hydrophobic drug can effect disintegrating time.

DISSOLUTION OF DRUGS FROM TABLETS.

From PHARMA formulation book

The required concentration the superdisintegrant can be used according to critical concentration of disintegrant. Superdisintegrant are decrease the disintegration time by various mechanisms. Factors such like Disintegration, compactability, mouth feel and flow should be considered when selecting super disintegrant.

Generally superdisintegrant are used at 2-5 wt % of the tablet in normal tablet formulation. In case of MDTs quantity of disintegrant should be higher for great flow with direct compression. To produce enough robust tablets compactable disintegrant should be chosen.

Crosspovidone, microcrystalline cellulose, sodium starch glycollate, sodium carboxy methyl cellulose, and modified corn starch should be used as superdisintegrant. Md kumar

Sometimes gas producing disintegrants are used for extra fast disintegration. Commonly mixtures of citric and tartaric acid with carbonates or bicarbonates are used. royal

Binder keep the formula together so right choice binder is important to keep the integrity and stability of tablet. Starch, sucrose, gelatine are common binder.

Bulking agent or Diluents or fillers: Diluents give bulk to formulation to prepare tablets in desired shape. Most common filler is lactose.

Selection of diluents in MDT is paramount for taste and better mouth feel. Filler should be chemically inert, non-hygroscopic, biocompactible, have good biopharmaceutical properties, and less cost. 405 aulton

Bulking agents used in this type of preparation should be more sugar based to improve textural characteristic. The examples of bulking agents include calcium carbonate, magnesium carbonate, calcium phosphate, calcium sulphate, pregelatinzed starch, magnesium trisilicate and aluminium hydroxide. Mannitol, polydextrose, lactitol and starch hydrolysate are sugar based bulking agents. Tech deshmukh

Lubricants improve the flow properties of mixture in the hopper. It also prevent sticking and reduce friction between the tablet and die. Magnesium stearate widely used lubricant. Lubricants give a sheen to final tablets. Stearic acids, magnesium stearate, zinc state, calcium state, talc, liquid paraffin, magnesium lauryl sulphate, colloidal silicon dioxide. Md saxena

Sweeteners added to mask taste of API and good taste and flavour. Pharmaceutical grade sachharides such as Mannitol, sucrose, lactose, glucose, and xylitol have been used in MDTs.

Colourant give identification and reduce patient compliance.

Various technologies:

The different technologies used for preparation of mouth dissolving tablet.

Freeze drying

Cotton candy process

Molding

Sublimation

Spray drying

Mass extrusion

Nanonization

Phase transition process

Direct compression

Freeze drying or lyophilisation

The manufacture of mouth dissolving tablets using lyophilisation involves a series of procedures. In this process preparation of aqueous solution or suspension placed in to tablet size moulded blister followed by specially designed freezing process. These blisters are than carried to freeze dryer for removing moisture. Shukla 1 Disadvantage of using this process is time consuming and expensive. Special packaging required due to poor stability and fragility of final product.

Zydis and Quicksolv is unique patent technology base upon freeze-dried technology.

Cotton candy process

Matrix of polysaccharides or saccharides has been produced by simultaneous action of flash melting and spinning. This matrix has better flow properties and compressibility. Then this candy matrix is milled and blended with active ingredient and compressed to tablet.

High dose of drug and improved mechanical strength can be achieved by this process but high process temperature limits the use of this process. 24 tech deshmukh

Molding

Tablet made from this process contain water-soluble ingredients so the tablets dissolve rapidly and completely. Flash tab is invented process by ethypharm based upon molding.

Powder is incorporated with hydro alcoholic solvent followed by compression at low pressure in molded plates to form a wetted mass. The solvent is than removed by air drying. The tablet made by this technique has less mechanical strength. Md chandan1516

Sublimation tech nidhi

Readily volatilize solid ingredients are added to other tableting agents, then mixture is compressed to make tablets. These tablets are then subjected to sublimation to crate porous tablets.

Spray drying

Spray drying can produce highly porous and fine powders that dissolve quickly. In this technique, particular support matrix produced by spray drying. This matrix mixed with drug and compressed into tablets. This tablet disintegrated within 20 second in aqueous medium. Techni

Mass extrusion md debjit

In this technology the active blend made soft by adding water soluble polyethylene glycol and methanol and pass this blend to syringe or extruder to get a cylinder of product. Then cylinder finally cut in to tablet shape using heated blade. The dried cylinder can also be used to coat granules for taste masking.

Nanonization

Recently developed technology involves reduction in the particle size of drug to nanosize by wet milling technique 62 shukla 1. The nanocrystals of the drug are stabilized against agglomeration by surface adsorption on stabilizers, which are then incorporated in to MDTs. This technique is very useful for poorly soluble drugs.

Phase transition process techniques

Compress the mixture of Low and high melting point sugar alcohol with active ingredient to make tablet. Then heating tablet at temperature between low and high melting point of sugars.

Direct compression 20 md royal

Porosity and wetting of water into tablets are important criteria to ensure quick dissolution of drug which depend upon mechanical strength of tablet. And another side fragility of tablet is also important.

As described above many techniques are available for manufacturing of mouth dissolving tablet but this techniques are time consumable, costly and special equipments are needed. Tablets made from direct compression method have good mechanical strength but low disintegration time 6 seong. This process is very simple. Just few steps is involved milling, powder mixing and tableting. Wet or dry granulation does not require. This method reduces production time and cost. Conventional equipment and commonly available excipient can be use for direct compression. High doses can be adapted. shilesh 22 bookmark

Tablets are made by compressing a formulation containing a drug or drug with excipients on tablet compressing machine. There are two types of tablet punching machine either single punch or multi punch rotary machine.

The type and quantity of disintegrant is primary cause for satisfactory quality of tablet in direct compression. OROSOLV and DURASOLV patents from CIMA labs have been described evolution of carbon dioxide as a disintegration mechanism.

Some precaution during direct compression is to avoid air entrapment because it causes the capping, splitting, or laminating of tablets. Forced feeders can reduce air entrapment, making the filler powder more dense and amenable to compaction.

Evaluation of MDTs:

There are different standard has been set regards to tablets in different pharmacopoeias.

The following standard test including:

General appearance

Size and shape

Organoleptic properties

Tablet thickness

Weight variation

Hardness

Friability

Wetting time and water absorption ratio

Disintegration time

Dissolution time

General appearance

The appearance of the tablet is important criteria. Standard size, shape, good colour, marking on the tablet, surface roughness and colour homogeneity of tablet is all exceptions of the patients and measure of quality.

Size and shape

The size of tablet frequently related with administered dose. Small size of tablet is easy for swallow. Capsule shaped tablet is more convenience for high dose materials with high compression weight is also needed. Pharmaceutical pre book Complicated shape of tablet require slower tabletting machine.

Organoleptic properties

Uniformity of colour is important for appearance for rich quality appeal. One study shows that patients presume thought about test depends upon shape and size of tablets. For example, orange colours tablets will be sour, blue tablets have bitter taste. So, right choice of colour is important factor.

International Journal of Biotechnology, R.K. Srivastava and colleagues some aesthetic considerations for over the-counter (OTC) pharmaceutical products" inInt. J. Biotechnol., 2010, 11, 267-283

The presence of an odour in a batch of tablet suggest stability problem however it could be characteristic of the drug or added sweetener or flavour. Taste of product is also important factor consider to patience acceptance.

Tablet thickness

Thickness of tablet is important factor for packaging because very thick tablets may not suitable in selected packaging or chosen quantity plastic container. Thickness can be measure by using calliper or micrometer. Changes in die fill, particle size distribution, compression force may causes variation in thickness. Book007 bookmark

Weight variation

To maintain proper amount of drug in tablet weight of tablet measured at time to time is important. The depth and volume of the fill must be adjusted to ensure desire weight and content of tablet. As per USP guidelines 10 is weighed individually and the average weight is calculated.

Friability

Paying attention on friability is necessary because many manufacturing method of MDTs are causes for friability. Friability test is help to find mechanical strength of the tablet against abrasion in production and transportation. The friability test is nearly being linked with hardness. The high friability suggest weight variation, poor quality, lack of consumer acceptance, and uniformity problem.

Normally Roche friabilator is used to measure friability. A number of tablets are placed in to the apparatus and run it for 5 minutes at 20 rpm. Where tablets fallen between 6 inches gap and weighed this weigh are compared with the initial weight. The loss of weight is expressed in percentage. Friability of tablet acted upon moisture content in tablet granules and in finished product. Some time poor surface edges or condition of punches are responsible for more friable product.

Hardness

Hardness mean the force required to break the tablet. It is also referred as crushing strength. Hardness is important for find out required compression force on tablet machine. Hardness of tablets depends upon applied compression force during manufacturing process and the characteristic of the granulation. Mixing time and amount of lubricants and excipients can also affect to hardness. Greater force require to breaking large size of tablets as compare to small tablets. Enough hardness of tablet is necessary to avoid damage during storage, transportation, and handling. Too hard tablet may result in less disintegrating time but if is too soft, it may not capable for later process as like coating or packaging and shipping procedures.

Lower range of crushing strength is quite beneficial to ensure quick disintegration of tablet in the mouth. To carry out this test tablet is placed between two anvils, and the force is recorded that causes the tablet to break. Different hardness testers are used as like the Pfizer tes.ter, the Erweka tester, the Schleuniger tester, the Strong-Cobb tester, and the Monsanto tester.

Wetting time and water absorption ratio

Disintegration testing is an important part of testing during production to ensure batch to batch uniformity. Disintegration test is determination the time taking out by tablet to disintegrate completely. Dissimilarity between disintegration times may be result of inconsistency and deficiency in batch. Highly compressed tablet has high disintegration time. Disintegration test carried on disintegration apparatus. The apparatus has a basket made from plastic material. Equal diameter of six tubes has been settled in the basket and proper mesh size is fixed to each of tubes.  The entire basket-rack assembly is movable by reciprocating motor which is fixed to the apex of the basket-rack assembly. The whole assembly is soaked up in large container with suitable buffer solution. Temperature of the container is also maintained by thermostat. Disintegration bookmark

Dissolution test

Dissolution test is method for measuring the rate of drug release from dosage form and emerging method for presumes bioavailability. Dissolution study of tablet in vitro is most important tool performed on pharmaceutical dosage forms. It explain lead to physiological availability of the drug but it is not about measurement of safety or efficacy of the tablet being tested.44 bookmark friability

Dissolution medium used for dissolution test in vitro must be aqueous, with assured pH, should assume in vivo conditions.

A different designed apparatus from single beaker to complicate structure are available for dissolution test. The physiochemical properties of dosage form consider for choosing appropriate apparatus. 47 bookmark friabi

Experiment

Material

Ibuprofen Sodium salt

Sucrose

Microcrystalline cellulose

Magnesium stearate

Suresphere

Carboxy methyl cellulose

Talc

Function of Ingrediant

Instruments used in experiment

The following instruments were used in experiments.

1. Tablet compressor Flexitab® 14yster manesty

2. Hardness tester Schleuniger-4M.

3. pH meter Corning pH meter 240.

4. Roche Friabilator Erweka TA.

5. Digital weighing machine OHAUS GA200.

6. UV spectroscopy Unicam

7. Dissolution apparatus Erweka

8. Disintegration tester Electrolab- JB pharmaton- ED2L

9. Micrometer Starrett

Method of preparation:

Ibuprofen mouth dissolving tablets were made by direct compression method using deferent ingredient as shown in table. All ingredients were blended in glass mortar for uniformity. Then mixture was compressed using Flexitab® 14yster manesty tablet punching machine using 2.5 mm standard punch. Each formulation compressed with 6KN and 8KN compression force.

Ingredient (mg)

Formulation

1

Formulation

2

Formulation

3

Ibuprofen

200

200

120

Sugar

80

80

90

Mg Stearate

4

4

3

Microcrystalline cellulose

65

10

60

Suresphere

5

60

27

Weight per each tablet

354

354

300

Result and Discussion

General appearance

C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\IMAG0023.jpg C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\f1 8kn.jpgFormulation 1 6KN Formulation 1 8KN

C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\f2 6kn.jpg C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\f2 8kn.jpg

Formulation 2 6KN Formulation 2 8KN

C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\f3 6kn.jpg C:\Users\hiren\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Word\f3 8kn.jpg

Formulation 3 6KN Formulation 3 8KN

Weight

F-a1

F-a2

F-b1

F-b2

F-c1

F-c2

0.25

0.247

0.322

0.271

0.335

0.315

0.246

0.251

0.308

0.263

0.341

0.315

0.249

0.245

0.312

0.272

0.348

0.312

0.248

0.246

0.312

0.265

0.345

0.314

0.246

0.247

0.306

0.265

0.344

0.312

0.247

0.248

0.305

0.271

0.345

0.312

0.245

0.248

0.307

0.266

0.346

0.311

0.245

0.246

0.309

0.265

0.344

0.314

0.244

0.247

0.31

0.267

0.339

0.316

0.248

0.245

0.311

0.266

0.347

0.315

Mean

0.2468

0.247

0.3102

0.2671

0.3434

0.3136

SD

0.001932

0.001764

0.004803

0.003107

0.003978

0.001713

Diameter

F-a1

F-a2

F-b1

F-b2

F-c1

F-c2

10.4

10.39

10.38

9.87

10.36

9.95

10.39

10.4

10.35

9.89

10.35

10.05

10.38

10.39

10.3

9.98

10.4

10.04

10.39

10.39

10.34

9.91

10.37

10.01

10.38

10.41

10.37

9.95

10.39

10.02

10.39

10.38

10.36

9.98

10.41

9.98

10.41

10.37

10.37

9.85

10.36

10

10.35

10.39

10.33

9.82

10.37

9.97

10.4

10.4

10.36

9.96

10.38

10.04

10.4

10.41

10.38

9.92

10.4

10.03

Mean

10.389

10.393333

10.35433

9.913333

10.379

10.00933

SD

0.016633

0.0124722

0.024848

0.055377

0.020248

0.033511

Hardness

F-a1

F-a2

F-b1

F-b2

F-c1

F-c2

4.00

4.39

2.4

2.7

3.2

3.94

4.10

4.78

1.9

2.5

3.4

4

4.40

3.95

2.32

3.3

3.2

3.95

4.12

3.86

2.41

2.75

3.3

3.98

4.29

4.25

2.39

2.79

3.4

4.1

4.16

4.33

2.35

2.76

3.8

4.1

4.13

4.2

2.42

2.82

3.7

3.98

4.09

4.5

2.34

2.75

3.5

4.2

4.24

4.6

2.33

2.76

3.3

4.2

4.27

3.99

2.32

2.75

3.4

3.95

Mean

4.18

4.285

2.318

2.788

3.42

4.04

SD

0.118134

0.29662

0.151716

0.199933

0.198886

0.101871

Friability

F-a1

F-a2

F-b1

F-b2

F-c1

F-c2

Initial weight

0.7524

0.7315

0.9392

0.8176

1.0324

0.9531

Final weight

0.7454

0.67

0.7543

0.6474

1.0002

0.9409

Loss of weight

0.007

0.0615

0.1849

0.1702

0.0322

0.0122

Calibration graph:

Concentration mg/ml

Stock solution (ml)

Phosphate buffer solution (ml)

Absorbance

(nm)

0.010

1

9

0.144

0.020

2

8

0.245

0.030

3

7

0.341

0.040

4

6

0.435

0.050

5

5

0.531

0.060

6

4

0.629

0.070

7

3

0.721

0.080

8

2

0.819

0.090

9

1

0.915

0.10

10

0

1.012

Dissolution

Time(Min.)

F-b2

Absorbance

F-c1

Absorbance

F-c2

Absorbance

0

0.011

0.021

0.018

0.5

0.035

0.026

0.068

1

0.058

0.029

0.096

1.5

0.071

0.04

0.145

2

0.083

0.046

0.178

2.5

0.099

0.059

0.199

3

0.131

0.074

0.237

3.5

0.148

0.091

0.258

4

0.172

0.101

0.265

4.5

0.175

0.112

0.277

5

0.19

0.126

0.282

10

0.196

0.133

0.288

15

0.2

0.14

0.292

20

0.206

0.145

0.298

25

0.209

0.148

0.301

30

0.211

0.154

0.305

35

0.212

0.157

0.305

40

0.212

0.159

0.307

45

0.212

0.159

0.307

As per calibration graph, y =0.010x at value of C supposed 0

And A = ECL (Beer-Lambert law) where, A = absorbance at given wavelength = y

E = Molar coefficient = 0.010

C = concentration = x

L = Length of light path = 1

If absorbance value = 0.035 of f-b2 at 0.5 minute place in A = ECL

0.035 = 0.010 * C

C = 3.5 mg/ml

Calculation of % of ibuprofen released at various time

In the formulation, 100 percentage of ibuprofen at 250 mg of ibuprofen

So, 3.5 mg of ibuprofen contain = (3.5 * 100) / 250 = 3.5% of ibuprofen released after 0.5 minute in case of f-b2.

For f-c, 120 mg of ibuprofen contain 100% of ibuprofen

Therefore, 2.6 at .5 minute for f-c1 = (2.6*100)/120 = 2.16 % of ibuprofen released.

As similarly, we can get following data of concentration and % of drug released

F-b2

Concentartion

% of drug release

0.011

1.1

0.44

0.035

3.5

1.4

0.058

5.8

2.32

0.071

7.1

2.84

0.083

8.3

3.32

0.099

9.9

3.96

0.131

13.1

5.24

0.148

14.8

5.92

0.172

17.2

6.88

0.175

17.5

7

0.19

19

7.6

0.196

19.6

7.84

0.2

20

8

0.206

20.6

8.24

0.209

20.9

8.36

0.211

21.1

8.44

0.212

21.2

8.48

0.212

21.2

8.48

0.212

21.2

8.48

F-c1

Concentration

% of drug release

0.021

2.1

1.75

0.026

2.6

2.167

0.029

2.9

2.417

0.04

4

3.333

0.046

4.6

3.833

0.059

5.9

4.917

0.074

7.4

6.167

0.091

9.1

7.583

0.101

10.1

8.417

0.112

11.2

9.333

0.126

12.6

10.500

0.133

13.3

11.083

0.14

14

11.667

0.145

14.5

12.083

0.148

14.8

12.333

0.154

15.4

12.833

0.157

15.7

13.083

0.159

15.9

13.250

0.159

15.9

13.250

F-c2

Concentration

% of drug release

0.018

1.8

1.500

0.068

6.8

5.667

0.096

9.6

8.000

0.145

14.5

12.083

0.178

17.8

14.833

0.199

19.9

16.583

0.237

23.7

19.750

0.258

25.8

21.500

0.265

26.5

22.083

0.277

27.7

23.083

0.282

28.2

23.500

0.288

28.8

24.000

0.292

29.2

24.333

0.298

29.8

24.833

0.301

30.1

25.083

0.305

30.5

25.417

0.305

30.5

25.417

0.307

30.7

25.583

0.307

30.7

25.583

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