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B. SADHANA
121725101002
M.PHARMACY 1 ST YEAR
PHARMACEUTICS
GITAM INSTITUTE OF PHARMACY
GITAM UNIVERSITY.
1
1. Introduction
2. Objective
3. Preparation
4. Approaches
5. Coating process
6. Evaluation
2
INTRODUCTION:
• The goal of any drug delivery system is to deliver a therapeutic amount of
drug to the specific site and then to maintain the desired drug concentration
at that particular site.
• Usually conventional dosage forms result in wide range of fluctuations in
drug concentration in the blood stream with consequent toxicity as a result of
poor efficiency.
• Mini tablets are formulations which come under multi unit dosage form.
• After administration, multiple units gets released into the stomach and
spread along the gastrointestinal tract resulting in consistent drug release
with reduced risk of local irritation.
3
Mini-tablets are flat or slightly curved tablets with a diameter
ranging between 1.0-3.0 mm.
They are usually filled into a capsule, occasionally compressed into
larger tablets, or sometimes placed in sachets for easy
administration.
4
OBJECTIVES:
• To achieve sustained or controlled delivery.
• To reduce the frequency of the dosing.
• To increase the effectiveness of the drug by localization at the specific site of
action.
• To achieve various releases with one formulation.
5
PREPERATION OF MINI TABLETS
The formulation process of mini-tablet systems can be divided into three
important steps:
The formulation/production of mini-tablets,
Coating of these mini-tablets with appropriate coating polymer,
Compressed into tablets or filling of coated mini-tablets into
hard gelatin or HPMC capsules (Mini-tablets-in-capsule systems)
6
APPROACHES OF MINI-TABLET DOSAGE FORMS:
1. Compressed mini-tablets
2. Encapsulated Coated mini-tablets
3. Compressed mini-tablets presented as a
biphasic drug delivery system
7
COMPRESSED MINI TABLETS:
•MUDF’s compressed into tablets.
•Because of their size uniformity, regular shape, smooth surface, low porosity
and high mechanical strength, mini-tablets can maintain their uniformity in a
more reproducible way than pellets or granules, once they have been
compressed into a tablet.
•Different compositions like hydrophilic and/or hydrophobic polymers and
number of mini-tablets can be used to obtain different drug release rates.
•Drugs suitable for this type of administration include Nonsteroidal anti-
inflammatory drugs (NSAIDs), antihypertensive, antihistaminic and anti-
allergic agents.
8
ENCAPSULATED COATED MINI TABLETS:
•Among all the possible formulations, encapsulated coated mini-tablets are
widely used as it improves drug tolerance and also yields a dose regimen that is
easier to manage for patients.
•Different mini-tablets can be placed into each capsule, tablets with various
combinations of drugs, dosage which later disintegrates and different drug
release profiles can be obtained. This results in improves patient compliance.
•A multifunctional and multiple unit system, containing different mini-tablets in
a hard gelatin capsule, can be developed by incorporating rapid-release mini-
tablets (RMTs), Sustained-release Mini-Tablets (SMTs), Pulsatile Mini-Tablets
(PMTs), and Delayed-onset Sustained-release Mini-Tablets (DSMTs), each with
various release rates.
9
•Encapsulated mini-tablets system usually comprises immediate-release mini-
tablets (IRMT) and sustained release mini-tablets (SRMT) in a capsule made up
of HPMC, a water-soluble polymer which later disintegrates and releases these
subunits into the system.
•Encapsulated minitablet systems can be designed to yield various sustained
release drug profiles by combining different types, quantities and combinations
of mini-tablets.
•Mini-tablets are usually coated with enteric coating polymers in fluid bed
coater or in modified coating pans.
•Drugs that cause irritation to gastric mucosa or inactivated in the stomach, can
be coated with a substance that will dissolve only in the small intestine.
10
MATERIALS USED FOR ENTERIC COATINGS MOSTLY INCLUDE:
•fatty acids
•waxes
•Phthalates[Cellulose acetate phthalate (CAP),Hydroxy propyl methyl
cellulose phthalate, Polyvinyl acetate phthalate (PVAP)]
•Methacrylic acid/ethyl acrylate
•Cellulose acetate succinate
•Cellulose acetate trimellitate
•Hydroxy propyl methyl cellulose acetate succinate, Sodium alginate
•stearic acid
•shellac
•plant fibres. 11
COMPRESSED MINI-TABLETS PRESENTED AS A BIPHASIC
DRUG DELIVERY SYSTEM:
•Mini-tablets can be used to produce a biphasic delivery system, by combining a
fast release form with a slow release form of the drug.
•The concept of double component is used to develop this biphasic drug delivery
system. Considering all these factors a new oral drug delivery system, double
component model is developed. In this, one component is formulated to provide
fast release of the drug to achieve a high serum concentration in a short period of
time. The other portion is a sustained release component, which is developed to
maintain constant plasma levels over defined periods of time.
12
•Biphasic delivery systems release the drug at two different rates and in two
different time periods, that is either quick/slow or slow/quick. A quick/slow
system provides an initial burst of drug release followed by a constant release
rate over a defined time period, whereas opposite is the case of slow/quick
release systems.
•Biphasic release system is used when relief needs to be achieved quickly, and
followed by a sustained phase to avoid repeated administration of the drug.
•Drugs suitable for biphasic drug delivery include analgesics, anti-
inflammatory drugs, antihypertensive, antihistaminic and anti-allergic agents.
13
EVALUATION:
Evaluation of the blend:
1. Bulk density
2. Tapped density
3. Compressibility index
4. Hausner’s ratio
Evaluation Tests for Coated Mini-tablets:
1. Weight variation
2. Hardness
3. Thickness
4. Diameter
Evaluation Tests for Encapsulated Mini-tablets:
1. Weight Variation Test
2. In-Vitro Drug Release
14
ADVANTAGES OF MINI-TABLETS:
•They can be manufactured relatively easily.
•They offer flexibility during the formulation development.
•They have excellent size uniformity, regular shape and a smooth surface,
thereby acts as an excellent coating substrate.
•They offer high degree of dispersion in the GI tract, thus minimizing the
risks of high local drug concentrations.
•They offer high drug loading, a wide range of release rate patterns, and also
fine tuning of these release rates.
•They are easy to coat unlike pellets and also requires less coating material
compared to granules.
15
CONCLUSION:
From this, it can be concluded that pharmaceutical mini-tablets offer several
advantages when compared to single unit dosage forms and are also good
substitutes for granules and pellets. They have well defined size, shape, surface,
low degree of porosity and high mechanical strength.
By combining different mini-tablets, incompatible drugs can be administered
and concurrent diseases can be treated effectively. Also, mini-tablets serve as a
potential new formulation for paediatric use, as they meet all the requirements
of paediatric drug delivery.
Ultimately, mini-tablets improves overall therapeutic outcome, patient
compliance and convenience. As they have significant advantages, they can be
formulated for most of the available and suitable drugs. So, the development of
mini-tablets for controlling drug release is an important focus of research in
oral controlled solid dosage forms.
16
16
REFERENCES:
1. Lopes CM, Sousa Lobo JM, Pinto JF, Costa P, Compressed mini-tablets as
a biphasic delivery system, International Journal of Pharmaceutics, 323(1–
2), 2006, 93–100.
2. Karthikeyan D, Vijayalaxmi A, Santhosh Kumar C, Formulation and
evaluation of biphasic Delivery system of Aceclofenac mini-tablets in Hard
gelatin capsules, International journal of novel trends in pharmaceutical
sciences, ISSN: 2277 – 2782, 3(2), 2013, 39-45.
3. Bhavik Solanki, Rutvik Patel, Bhavesh Barot, PunitParejiya, Pragna Shelat,
Multiple Unit Dosage Forms: A Review, Pharmtechmedica, 1(1), 2012, 11-
21.
4. Jitender Joshi, Lata Bhakuni, Sachin Kumar, Formulation and evaluation of
solid matrix tablets of Repaglinide, Der Pharmacia Sinica, Pelagia Research
Library, ISSN: 0976-8688, 3(5), 2012, 598-603.
5. Mirelabodea, Ioan tomuţă, Sorin leucuţa, Identification of Critical
Formulation Variables for Obtaining Metoprolol tartrate Mini-tablets,
Farmacia, 58, 2010, 719-727.
16

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121725101002-Mini tablets.pptx

  • 1. B. SADHANA 121725101002 M.PHARMACY 1 ST YEAR PHARMACEUTICS GITAM INSTITUTE OF PHARMACY GITAM UNIVERSITY. 1
  • 2. 1. Introduction 2. Objective 3. Preparation 4. Approaches 5. Coating process 6. Evaluation 2
  • 3. INTRODUCTION: • The goal of any drug delivery system is to deliver a therapeutic amount of drug to the specific site and then to maintain the desired drug concentration at that particular site. • Usually conventional dosage forms result in wide range of fluctuations in drug concentration in the blood stream with consequent toxicity as a result of poor efficiency. • Mini tablets are formulations which come under multi unit dosage form. • After administration, multiple units gets released into the stomach and spread along the gastrointestinal tract resulting in consistent drug release with reduced risk of local irritation. 3
  • 4. Mini-tablets are flat or slightly curved tablets with a diameter ranging between 1.0-3.0 mm. They are usually filled into a capsule, occasionally compressed into larger tablets, or sometimes placed in sachets for easy administration. 4
  • 5. OBJECTIVES: • To achieve sustained or controlled delivery. • To reduce the frequency of the dosing. • To increase the effectiveness of the drug by localization at the specific site of action. • To achieve various releases with one formulation. 5
  • 6. PREPERATION OF MINI TABLETS The formulation process of mini-tablet systems can be divided into three important steps: The formulation/production of mini-tablets, Coating of these mini-tablets with appropriate coating polymer, Compressed into tablets or filling of coated mini-tablets into hard gelatin or HPMC capsules (Mini-tablets-in-capsule systems) 6
  • 7. APPROACHES OF MINI-TABLET DOSAGE FORMS: 1. Compressed mini-tablets 2. Encapsulated Coated mini-tablets 3. Compressed mini-tablets presented as a biphasic drug delivery system 7
  • 8. COMPRESSED MINI TABLETS: •MUDF’s compressed into tablets. •Because of their size uniformity, regular shape, smooth surface, low porosity and high mechanical strength, mini-tablets can maintain their uniformity in a more reproducible way than pellets or granules, once they have been compressed into a tablet. •Different compositions like hydrophilic and/or hydrophobic polymers and number of mini-tablets can be used to obtain different drug release rates. •Drugs suitable for this type of administration include Nonsteroidal anti- inflammatory drugs (NSAIDs), antihypertensive, antihistaminic and anti- allergic agents. 8
  • 9. ENCAPSULATED COATED MINI TABLETS: •Among all the possible formulations, encapsulated coated mini-tablets are widely used as it improves drug tolerance and also yields a dose regimen that is easier to manage for patients. •Different mini-tablets can be placed into each capsule, tablets with various combinations of drugs, dosage which later disintegrates and different drug release profiles can be obtained. This results in improves patient compliance. •A multifunctional and multiple unit system, containing different mini-tablets in a hard gelatin capsule, can be developed by incorporating rapid-release mini- tablets (RMTs), Sustained-release Mini-Tablets (SMTs), Pulsatile Mini-Tablets (PMTs), and Delayed-onset Sustained-release Mini-Tablets (DSMTs), each with various release rates. 9
  • 10. •Encapsulated mini-tablets system usually comprises immediate-release mini- tablets (IRMT) and sustained release mini-tablets (SRMT) in a capsule made up of HPMC, a water-soluble polymer which later disintegrates and releases these subunits into the system. •Encapsulated minitablet systems can be designed to yield various sustained release drug profiles by combining different types, quantities and combinations of mini-tablets. •Mini-tablets are usually coated with enteric coating polymers in fluid bed coater or in modified coating pans. •Drugs that cause irritation to gastric mucosa or inactivated in the stomach, can be coated with a substance that will dissolve only in the small intestine. 10
  • 11. MATERIALS USED FOR ENTERIC COATINGS MOSTLY INCLUDE: •fatty acids •waxes •Phthalates[Cellulose acetate phthalate (CAP),Hydroxy propyl methyl cellulose phthalate, Polyvinyl acetate phthalate (PVAP)] •Methacrylic acid/ethyl acrylate •Cellulose acetate succinate •Cellulose acetate trimellitate •Hydroxy propyl methyl cellulose acetate succinate, Sodium alginate •stearic acid •shellac •plant fibres. 11
  • 12. COMPRESSED MINI-TABLETS PRESENTED AS A BIPHASIC DRUG DELIVERY SYSTEM: •Mini-tablets can be used to produce a biphasic delivery system, by combining a fast release form with a slow release form of the drug. •The concept of double component is used to develop this biphasic drug delivery system. Considering all these factors a new oral drug delivery system, double component model is developed. In this, one component is formulated to provide fast release of the drug to achieve a high serum concentration in a short period of time. The other portion is a sustained release component, which is developed to maintain constant plasma levels over defined periods of time. 12
  • 13. •Biphasic delivery systems release the drug at two different rates and in two different time periods, that is either quick/slow or slow/quick. A quick/slow system provides an initial burst of drug release followed by a constant release rate over a defined time period, whereas opposite is the case of slow/quick release systems. •Biphasic release system is used when relief needs to be achieved quickly, and followed by a sustained phase to avoid repeated administration of the drug. •Drugs suitable for biphasic drug delivery include analgesics, anti- inflammatory drugs, antihypertensive, antihistaminic and anti-allergic agents. 13
  • 14. EVALUATION: Evaluation of the blend: 1. Bulk density 2. Tapped density 3. Compressibility index 4. Hausner’s ratio Evaluation Tests for Coated Mini-tablets: 1. Weight variation 2. Hardness 3. Thickness 4. Diameter Evaluation Tests for Encapsulated Mini-tablets: 1. Weight Variation Test 2. In-Vitro Drug Release 14
  • 15. ADVANTAGES OF MINI-TABLETS: •They can be manufactured relatively easily. •They offer flexibility during the formulation development. •They have excellent size uniformity, regular shape and a smooth surface, thereby acts as an excellent coating substrate. •They offer high degree of dispersion in the GI tract, thus minimizing the risks of high local drug concentrations. •They offer high drug loading, a wide range of release rate patterns, and also fine tuning of these release rates. •They are easy to coat unlike pellets and also requires less coating material compared to granules. 15
  • 16. CONCLUSION: From this, it can be concluded that pharmaceutical mini-tablets offer several advantages when compared to single unit dosage forms and are also good substitutes for granules and pellets. They have well defined size, shape, surface, low degree of porosity and high mechanical strength. By combining different mini-tablets, incompatible drugs can be administered and concurrent diseases can be treated effectively. Also, mini-tablets serve as a potential new formulation for paediatric use, as they meet all the requirements of paediatric drug delivery. Ultimately, mini-tablets improves overall therapeutic outcome, patient compliance and convenience. As they have significant advantages, they can be formulated for most of the available and suitable drugs. So, the development of mini-tablets for controlling drug release is an important focus of research in oral controlled solid dosage forms. 16
  • 17. 16 REFERENCES: 1. Lopes CM, Sousa Lobo JM, Pinto JF, Costa P, Compressed mini-tablets as a biphasic delivery system, International Journal of Pharmaceutics, 323(1– 2), 2006, 93–100. 2. Karthikeyan D, Vijayalaxmi A, Santhosh Kumar C, Formulation and evaluation of biphasic Delivery system of Aceclofenac mini-tablets in Hard gelatin capsules, International journal of novel trends in pharmaceutical sciences, ISSN: 2277 – 2782, 3(2), 2013, 39-45. 3. Bhavik Solanki, Rutvik Patel, Bhavesh Barot, PunitParejiya, Pragna Shelat, Multiple Unit Dosage Forms: A Review, Pharmtechmedica, 1(1), 2012, 11- 21. 4. Jitender Joshi, Lata Bhakuni, Sachin Kumar, Formulation and evaluation of solid matrix tablets of Repaglinide, Der Pharmacia Sinica, Pelagia Research Library, ISSN: 0976-8688, 3(5), 2012, 598-603. 5. Mirelabodea, Ioan tomuţă, Sorin leucuţa, Identification of Critical Formulation Variables for Obtaining Metoprolol tartrate Mini-tablets, Farmacia, 58, 2010, 719-727.
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