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A REVIEW ON PULSATILE DRUG DELIVERY SYSTEMS

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A REVIEW ON PULSATILE DRUG DELIVERY SYSTEMS

P. S. S. Prasanna Kumar * and L. Srinivas

Department of Pharmaceutics, GITAM School of Pharmacy, GITAM Deemed to be University, Rushikonda, Vishakhapatnam, Andhra Pradesh, India.

ABSTRACT: In present days, solid oral drug dosage forms are widely used and the largest part of the entire drug delivery system due to their more, easy preferable route of administration and improved patient convenience nature. Most of the oral drug delivery systems show a distinctive drug release pattern, and the drug concentration is maintained within the limit of the therapeutic range. With technological advancement, pulsatile medication delivery devices are becoming increasingly important and popular for controlled delivery systems based on drug design. It maintains the circadian rhythm of the disease conditions and reduces the side effects of the drug. So, the important action of pulsatile drug delivery systems is used to delivery the drug at right time, site or target, and quantity. The drug release follows the sigmoid al release pattern, characterized by a period of no release (lag time). These systems release or deliver the drug based on the pathophysiological need of the disease at a specific time. So, it improves the therapeutic efficacy, compliance of the patient and decreases dosing frequency.

Keywords: Circadian rhythm, Lag time, Pulsatile, Chronological behavior

INTRODUCTION: The Pulsatile drug delivery systems (PDDS) show great importance, interest due to complete drug release and follow the pattern of drug release after Lag time. So, the pulsatile systems are based on time, site-specific systems. Hence, these systems are designed to deliver the medication quickly and bursts in a short period after a predetermined off-release Period. So, drug release from the dosage form as a pattern of “pulse” after the lag time 1, 2.

Two phases characterize the PDDS release: In that, the initial phase shows the release of small amount of the drug and is continued by the next phase, in which the complete release of the drug takes place in a short period of lag time 3.

FIG. 1: RELEASE OF DRUG PROFILE FROM VARIOUS DELIVERY SYSTEMS (A) PULSATILE (B) CONVENTIONAL (C) EXTENDED

Chronobiology is the study of science concerned with biological rhythms and mechanisms. The presence of body biological rhythms is categorized into three categories as follows

TABLE 1: TYPES OF BIOLOGICAL RHYTHMS 4

S. no. Name of the Biological Rhythm Oscillations Duration of time
1 Circadian (Derived from the Latin words circa means “about’’ & dies means “day’’). Oscillations of a Day  (Completed within a day or 24 hours)
2 Ultradian The Oscillations are shorter durations type (>01cycle/24 hours)
3 Infradian The Oscillations are longer durations type (<01 cycle/24 hours)

Diseases and Chrono Therapeutics 5: Circadian rhythms are endogenous oscillations that occur periodically for about 24 hours and involve regulating many body functions of metabolism, sleep pattern, and hormone production.

TABLE 2: DISEASE, CHRONOLOGICAL BEHAVIOUR, DRUG TREATMENT 5

Disease Chronological Behaviour Drugs used for treatment
Arthritis Pain occurs at night NSAIDS
Peptic Ulcer Increase Acid secretion at afternoon and night sessions H2 blocker
Asthma During night time and early morning hours Antihistamine, β2 blocker
Diabetes After a meal increased level in the blood Insulin, Sulfonylurea
Hypercholesterolemia At night time Higher levels of cholesterol level when compared to daytime HMG CoA reductase inhibitors
Cardiovascular disease Reduced level of Blood pressure during sleep time and increased level in early morning ACE inhibitors, Calcium channel blockers, Nitroglycerine
Duodenal Ulcers Increased night-time gastric acid secretion and a slower rate of gastric emptying, gastric, small bowel motility Inhibitors of proton pump
Cancer Three-fold highest in the flow of blood to tumors and growth of tumors in every daily activity stage of the circadian cycle Taxanes, Alkaloids like Vinca
Neurological disorders The primary pathophysiology of epilepsy, classification of behavioral convulsive event Inhibitors of MAO
Attention deficit syndrome In the afternoon time to observe High levels of DOPA Methylphenidate

Advantages 6, 7:

  1. It shows better and increased bioavailability and absorption processes than conventional immediate and sustained release dosage forms due to the release pattern being present in a burst manner and targeting the site.
  2. Decreases the drug dose without affecting the drug's therapeutic activity.
  3. Reduces the side effects compared to other conventional dosage forms.
  4. It improves patient compliance nature.
  5. Multiple dosing is possible in a single dose of pulse type of system.
  6. Less risk of local irritation.
  7. Greater stability in dosing.
  8. Specific release.
  9. To prevent drug loss by first-pass metabolism.
  10. Suitable for the body’s circadian rhythms functioning system behavior of Diseases.

Disadvantages 6, 7:

  1. Large number of manufacturing steps involved in production.
  2. Production cost is also high and requires advanced technology.
  3. Low drug loading capacity is possible.
  4. Lack of manufacturing units.

Need of Pulsatile Drug Delivery 8:

  1. Body rhythm follows circadian rhythms.
  2. Some Hormones modify the Circadian rhythm ex: rennin, aldosterone, cortisol, etc.
  3. Some diseases like bronchial asthma, myocardial localized necrosis, angina pectoris, rheumatic infection, ulcer, and hypertension showed time reliance.
  4. Importance of Lag time is essential for some drugs that undergo degradation in gastric acidic medium conditions.
  5. Some drugs undergo broad first-pass metabolism.

Mechanisms Involved in PDDS 9: The release of drug from the dosage form follows: Diffusion type, Erosion type, and Osmosis type.

Diffusion: Release of drug from the coating material to the outside based on the diffusion process, in which water diffuses into the particle inside and shows interaction with the GI tract fluids.

Erosion- Some of the coating materials intended to dissolve steadily with time and release of the drug contained inside the molecule.

Osmosis: An osmotic agent present inside of the molecule and it interacts with the water to generate osmotic pressure so the release of drug molecules to the outside with a covering.

Methods used for PDDS:

  1. Time controlled
  2. Stimuli induced

III. External regulated

  1. Time-controlled PDDS:
  2. Single-unit pulsatile system
  3. i) Based on Capsule type (Pulsincap System type)
  4. ii) Based on a Capsular system with Osmosis type
  5. a) PORT System
  6. b) Expandable orifice System
  7. c) Pulsatile drug delivery by solubility modulation
  8. d) Delivery by series of stops

iii) Pulsatile system contains erodible/ soluble barrier coatings

Compressed tablets, Multilayered tablets, Time clock Systems, Chronotropic Systems.

  1. iv) Pulsatile systems with rupturable coating
  2. Multi-particulate / Multiple unit systems
  3. i) Pulsatile system with a rupturable coating
  4. ii) Rupturable coating by Osmotic system

iii) Pulsatile Delivery by modifications in the Membrane Permeability

  1. Stimuli Induced:
  2. i) Temperature-induced type
  3. ii) Chemical-induced stimuli type
  4. a) Glucose-responsive insulin release
  5. b) Inflammation-induced
  6. c) Release of drug from intelligent gels responding to antibody concentration
  7. d) Electrical stimuli responsive pulsatile
  8. e) pH-sensitive type of drug delivery

III. External Regulated:

  1. i) Electro responsive to drug release
  2. ii) Stimulation by ultrasonically method

iii) Stimulation by the magnetically induced method

Time-controlled PDDS:

Single Unit Pulsatile Systems: The single-unit systems show the release of drugs based on the capsule type of system.

Capsule-Based Type Systems-Pulsing Cap Type 10, 11: In this type of system, the lag time is controlled by a design “Plug” and it is pushed away from the capsule by the process of swelling/erosion after that it forms a Pulse and release of the drug from the capsule body so lag time is can be modified with manipulation of dimensions, Plug position.

Polymers used for the process of designing hydrogel plug-like swellable polymers but Insoluble and permeable nature (ex: Polymethacrylates), Compressed erodible polymer nature (ex: HPMC, PVA, PEO), Congealed melted polymer nature (ex: glyceryl monooleate), Enzymatic Erodible polymer nature (ex: Pectin).

FIG. 2: PULSIN CAP SYSTEM DESIGN

Capsule Systems with Osmosis Type 12, 13:

PORT System: It consists of a capsule with a semipermeable coating membrane. The insoluble plug is inside the capsule body and contains an insoluble plug along with an osmotically active agent and drug formulation. When the capsule's contact with the dissolution fluid, water can enter through the coated semipermeable membrane, creating pressure. The insoluble plug was expelled after the lag time and helps to avoid the second dose type.

FIG. 3: PORT TYPE OF DESIGN. (A)Port type system B) Release of the drug after swelling of cap C) Permeation of GI Fluid with internal pressure generation D) Plug Release E) 2nd release of drug in sustained/Pulsed form

Expandable Orifice System 14: In these systems, the delivery of the drug is a liquid form. So, an osmotically driven capsular system is based on the absorbed liquid drug into the highly porous particles with the help of an orifice to deliver the drug by semipermeable membrane orifice containing capsule which is enclosed by expanding osmotic layer.

FIG. 4: EXPANDABLE ORIFICE SYSTEM

Delivery by Series of Stops 15: It is presented for an implantable type of capsule system in which the capsule contains a drug, water absorptive osmotic agent, which is placed in the compartments with the separation of a movable partition. So, the series of stops, along with the inner wall containing the capsule which is helpful for drug delivery.

Pulsatile Delivery by Solubility Modulation 16: It includes drug and solubility modulating agent (Sodium chloride), so delivery of drug release from the PDDS by several modifications. The pulsatile drug delivery depends on the solubility of the drug. The modulating agent used in the PDDS may be an organic acid/inorganic salt. To control the release of zero order and the beginning of the pulse release, using the ratio of the drug and modulating agent can be varied. So, after the release of the zero-order time period the drug delivers as a large pulse.

Pulsatile System Contains Erodible/Soluble Barrier Coatings 17: It consists of a reservoir type of system with an obstruction layer. The obstruction layer erodes/break up after the particular lag period, release of drug is rapid from the reservoir core. So, the covering layer thickness influences the Lag period.

Chronotropic Systems: Drug-containing core covered by swellable hydrophilic polymers and is important for the lag time at starting drug delivery. So, the variations in the thickness and grades of polymer type influence the controlling of lag time. The changes in the film thickness achieve time clock systems-Controlling of the lag time. After that, the lag time is required for rehydration, and the drug core promptly delivers the drug.

Compressed Tablets: The process of direct compression on both core and coat material with the help of different coating methods and utilizing the coating arrangements. The outermost layer of the tablet represents the first initial dose which is fast disintegration in the stomach, and the inner layer of the tablet with a selected polymer that is insoluble nature in the gastric medium but releases the drug in the intestine.

Multilayered Tablets: Two pulses are generated with a three-layer tablet model, which consists of drug layers and is separated by a polymer of a free gellable layer.

FIG. 5: MULTI-LAYERED TABLET

Multi-particulate/Multiple Unit Type Systems:

Pulsatile System with Erodible or Soluble Barrier Coatings 18, 19: The number of PDDS systems are present in the form of reservoir type systems with a barrier layer so the used barrier is soluble, erodible in nature after a specific lag time period so the drug release rapidly from the system of drug containing reservoir core. So, the lag time period is completely depending on the coating layer thickness. In Chronotropic system drug core (In Tablets and capsules) is coated by hydrophilic swellable polymers. Conversely the lag time period is depending on the layer thickness and Viscosity of polymer grades. In compressed tablet system, the direct compression technique is used to compress coating of both the core and coat. The outer compressed coated tablet shows the initial dose with fast disintegration and the inner compressed layer consists of insoluble components in the gastric media but soluble drug, release in the intestine in multilayer tablet system.

Pulsatile Systems with Rupturable Coating 20, 21:

The release of the drug is based upon the process of coating layer disintegration. Effervescent, swelling and osmotic pressure producing excipients are used to create pressure for rupturing of the coating layer. A combination of citric acid, sodium bicarbonate is used in the core of the tablet formulation, which is completely coated with ethyl cellulose polymer so liberation of CO2 gas after the water penetration into the tablet core results in the release of the drug as a pulsatile type after the rupturing layer of coating. Example: Time-controlled system of Explosion, in this the active medicament, is completely coated with the non-pareil sugar seeds followed by a swellable, insoluble top layer.

Rupturable Coating by Osmotic-Based Systems: It consists of a combination of both osmotic and swelling agent effects. The drug, low bulk density containing lipid substance and disintegrating agent present in the core and finally coated with cellulose acetate polymer. So, the drug core is in contact with the aq. media water penetrate into the drug core and displacing the lipid substance. The lipid material depletion leads to an increase in the internal pressure until it reaches critical stress and it shows the rupturing of the coating.

Stimuli-induced PDDS 22: The Release of drugs by the influence of stimuli based on the factors like high temperature and any chemical agent.

Temperature-induced Pulsatile Release 23: Thermoresponsive hydrogels are used to induce stimuli type of drug delivery. In this method, swelling and de-swelling of polymer stages occurs in response to the high temperature.

Chemical-induced Stimuli Pulsatile System:

Glucose-responsive Insulin System 24: Several devices are designed to respond to changes in glucose concentration. The enzyme Glucose oxidase catalyzes the oxidation process of Glucose.

Inflammation-induced Pulsatile Systems 25: In physical or chemical stress like broken bones, injury, etc., inflammation occurs at the injury site. So, at the inflammatory sites, the inflammation-responsive phagocytic sites, the macrophages, and polymorphonuclear cells play an important role in the injury process of healing.

Release of Drug from Intelligent Gels Responding to Antibody Concentration 26: Several Bioactive components are present in the Body. Therefore, the development of novel gels with bioactive components concentration changes and alters their swelling and/or deswelling properties.

Electric stimuli responsive PDDS 27: Iontophoresis, Infusion Pumps, and sonophoresis technologies are used to stimulate the swelling /deswelling characteristics of the polymer containing hydrogel.

pH-Sensitive Type of Drug Delivery Systems 28: It consists of two segments. The first one is quick discharge, and the other is beat discharge type. Discharge the drug based on the response to change in pH.

External Regulated Pulsatile Drug Delivery 29: In which the release of the drug can be externally regulated by ultrasound, electrical, magnetic, and irradiation (light) stimuli. In a magnetic regulated system, magnetic beads are placed in the implant so the drug release occurs from the magnetic field application. In an ultrasound system, the ultrasonic waves show erosion of the polymer matrix. In the Irradiation method, irradiation of light rays is used for drug release, and the light irradiation light rays desire the pattern of drug release by drug exposed to light. In Electric induced system, the presence of both electro and pH-sensitive responsive systems causes drug release.

Recent Advanced Technologies used in Pulsatile Drug Delivery Systems 30, 31: The number of recent technologies are used for various disease treatments to release the required drug amount at different intervals. Hence, mostly multiparticulates are used compared to single unit dosage form due to greater flexibility in blending with different release patterns, dose dumping is not possible, and reproducible short gastric residence time Various PDDS technologies developed on the basis of methodologies.

TABLE 3: TECHNOLOGIES IN PULSATILE DRUG DELIVERY SYSTEMS

S. no. Name of the Technology Description
1 Pulsincap Technology 32,33 The Pulsincap system consists of a non-breakable half-case body with open end type, attached with a hydrogel plug, and covered with a water-dissolving cap. So, the entire capsule is covered with an enteric polymer used to avoid gastric emptying. When the capsule interacts with the dissolution fluid medium, it shows swelling property nature after the lag time period so the attachment propels to outside and releases the drug quickly.
2 OROS 34,35

Proprietary name: Chronset

 

 The delivery system delivers the drug reproducibly based on the time or site-specific model in the GIT. It is completely based on the Osmosis model, in which the tablet containing the drug is present in the form of a reservoir enclosed by the semipermeable membrane with a laser-drilled orifice to deliver the drug. The bilayer and trilayer tablet systems consist of two layers with drug and osmotically active agents. When contact with the GI fluid the osmotically active agent generates the pressure and pushes the drug layer and releases of a drug through an orifice.
3 IPDAS36 It is another type of oral approach system of medication used for GI aggravation medications like NSAID category. So, this type of innovation is completely based on multiparticulate systems, in which high thickness/density-controlled discharge dots/beads are compacted into the tablet form. After ingestion of the IPDAS tablet, the rapid disintegration of the tablet, scatter globules containing the drug in the stomach, passes through the duodenum along with the GI tract in a continuous and controlled release manner. The drug release is based on the process of diffusion through a layer of polymer or micro matrix system of drug-polymer formation in the extruded multiparticulate system.
3 CEFORM 37,38 It consists of a uniform size and shape containing spherical microspheres with 150-180mm with high drug based on the process of melt spinning method in which the biodegradable polymer with combination to temperature, mechanical type of force, thermal gradients and flow of rate during the process. So, the obtained microspheres are used in a number of dosage forms like Capsules, tablets, suspensions, and effervescent-type tablets. The coated microspheres with enteric polymers are used for controlled release.
4 DIFFUCAPS 37-39 The capsule-based system with single or more drug particles includes beads, pellets and granules. Each particle expresses the preprogrammed release pattern with rapid /sustained action with /without a lag time. Diffucap system comprises a number of layers with drug release-controlling polymers and Excipients. The particles contain the organic acid/alkaline buffer, which is used to control the drug solubility.
5 EGALET 39,47 Delayed release type of system with an impermeable shell containing two lag plugs enclosing the drug plug present in the middle of the unit. So, by erosion, an inert plug leads to drug release. The time taken to erode the inert plug determines the lag time. The shells are made up of plasticizers and biodegradable polymers but the mixture of plugs are pharmaceutical additives that are polymer like polyethylene oxide.
6 CHRONOTOPIC 40 It is similar to a soluble erodible/rupturable membrane type of system. It comprises of drug core and is coated with an outer controlling release layer. The unit type of single, multiple dosage forms like tablets, capsules, mini type of tablets, pellets are used as inner formulations of the drug in the dosage form.
7 CODAS 41 It is a multiparticulate system for bedtime dosing. In which non-enteric coating layers are applied to drug beads, to delay the drug release up to 04-05hrs. For coating, the polymers of water-soluble and insoluble are used so the dosage form interacts with the GI fluid, the water-soluble polymer slowly dissolved to create apertures or pores on the coated layer; thereby the drug diffuses from the pores, and water-insoluble polymer represents the barrier and to maintain the drug release in a controlled manner.
8 TIMERx 42 This system is a hydrogel-based type device with controlled release. It provides the release of drugs from zero to chronotropic and shows different release kinetics. Basically, this system contains xanthan gum and locust bean gum by dextrose so a physical interaction occurs between the compounds to form a strong gel bonding in the presence of water. The release of the drug is controlled by the penetration of water, from the GI fluid into the TIMERx type of gum matrix system and expansion occurs finally to form a gel, release of the drug.
9 SODAS 42,43 It is a high-density type of multi-particulate system proposed for GIT irritant compounds and the controlled release beads characterized by its inherent flexibility nature. Consequently, it includes immediate drug release followed by sustained drug release and it is maintained for up to 24hrs.
10 PULSYS 42-44,47 This type of technology is used in the Chrono therapeutic system of amoxicillin. The importance of this system used by antibiotics shows a very effective nature against fast-growing bacteria. In the Immediate type of release system administration, the response of bacteria is a dormant stage, but in the pulsatile system, it is very effective due to the release of drug pulses after regular intervals of time and doesn’t allow the bacteria again into the dormant stage.
11 GEOCLOCK 45 In this type, the tablet layers contain the drug inside and a combination of hydrophobic wax and brittle components outside to get the pH-independent lag prior to the drug core delivering the drug at a programmed drug release rate. Thus, this dry type of coating method was developed to design the slow and fast release of the drug by first releasing the inside layer of the tablet after the surrounding outer layer shell disintegrates gradually.
12 DIFFUTAB 46 The Diffutab technology contains a fusing mixture of waxes and polymers (hydrophilic nature) which controls the discharging of drugs through the dissemination, and disintegration of grid tablets. This system is valuable in high-portion drugs with supporting drug delivery, once-a-day dosing.
13 MINITABS 47 The small size(mm) tube shaped (2×2) tablets covered with a layer of film to control the drug's discharge rate. So, the minitabs contain a gel nature containing components that are used to control the discharge rate of the drug but in some cases additions of extra layers are used to control the delivery of the drug.
14 3D PRINTING 47,48 This technique is helpful in the complications of internal geometries, different densities and chemicals. By using this technique, A number of oral drug delivery complex devices are fabricated into immediate, extended-release, pulse release and Dual pulse tablets. So, in this product formation the design by a computer screen as 3D type of model but before their actual implementation of the preparation process.
15 ORBEXA 49 The innovation is a multiparticulate type of system that permits high content of drug loading and depends on the granulation process. Using the techniques of granulation, spheronization and expulsion produces the controlled size, thickness of dots and is used in different types of drug delivery like postponed discharge, site-specific, supported and pulsatile delivery. The obrexa dots are filled in the single portion of sachets/Cases.

TABLE 4: LIST OF MARKETED PULSATILE DRUG DELIVERY TECHNOLOGIES 50-54

S. no. Name of the Drug in the Market product Registered trade mark Technology used Indication
1 Verapamil HCl Coveras-HS OROS Hypertension
2 Paliperidone Invega OROS Schizophrenia
3 Diltiazem HCl Cardizem LA CEFORM Technology Hypertension
4 Oxybutynin HCl Cystrin Cr TIMERx Urinary incontinence

Hypertension
5 Verapamil HCl Innopran XL DIFFUCAPS
6 Oxymorphone OPANA TIMERx Pain management
7 Verapamil HCl Verelan PM CODAS Hypertension
8 Famotidine Pepcid Drug modifications in Physicochemical properties Ulcer
9 Theophylline Uniphyl Contin Asthma
10 Simvastatin Zocor Drug physiochemical modification Hypercholesterolemia
11 Methylphenidate HCl Ritalin LA SODAS Attention deficit hyperactivity disorder
12 Molsidomine Coruno Geomatrix Chronic angina pectoris

CONCLUSION: In oral-type of dosage forms, the Sustained, controlled drug delivery systems showed great success in the delivery of medication but failure in the drug delivery given to the circadian behavior of the diseases. Hence, the pulsatile systems are very beneficial and increase the therapeutic effectiveness of the medication and improve the patient compliance effect in chronic problems. The pulsatile drug delivery systems deliver the drug at the right time, place, and amount. So, these systems are very beneficial to the patients based on the circadian behavior of the disease. The circadian time structure, disease rhythm pathophysiology, and medicine Chrono pharmacology knowledge help develop and design chronotherapeutic dosage forms and effective treatment of disease with minimizing the undesirable effects, target drug delivery, and non-constant dosing.

ACKNOWLEDGEMENT: The authors thank the GITAM School of Pharmacy for providing the required facilities for a review article.

CONFLICTS OF INTEREST: Declared None.

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    How to cite this article:

    Kumar PSSP and Srinivas L: A review on pulsatile drug delivery systems. Int J Pharm Sci & Res 2023; 14(7): 3246-54. doi: 10.13040/IJPSR.0975-8232.14(7).3246-54.

    All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.

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3246-3254

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English

IJPSR

P. SS. Prasanna Kumar * and L. Srinivas

Department of Pharmaceutics, GITAM School of Pharmacy, GITAM Deemed to be University, Rushikonda, Vishakhapatnam, Andhra Pradesh, India.

pssprasanna1@gmail.com

04 October 2022

25 November 2022

28 November 2022

10.13040/IJPSR.0975-8232.14(7).3246-54

01 July 2023

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