Osmotic Delivery System Research Articles

Biopolymer Packaging Materials in the Pharmaceutical Industry

Biopolymer packaging materials are gaining prominence in the pharmaceutical industry due to environmental concerns. Derived from renewable sources, these biopolymers offer biodegradability, biocompatibility, and non-toxicity, making them ideal for various pharmaceutical applications. In drug delivery, biopolymers play a crucial role in controlled release formulations, especially for personalized medicines and biopharmaceutical products. Hydrogels, three-dimensional polymer networks, are key in mimicking living tissues and facilitating stimuli-responsive drug release with minimal toxic effects. The formulation strategies involve diffusion-controlled, degradation-controlled, or environmentally triggered release. Biodegradable systems, using polymers like poly(lactic acid) and poly(glycolic acid), contribute to sustainable drug delivery by undergoing controlled degradation. Osmotic delivery systems leverage osmotic pressure for controlled drug release, while stimuli-responsive designs respond to environmental changes. Biopolymer integration in pharmaceutical packaging aligns with eco-friendly practices, addressing challenges posed by traditional petroleum-based materials. This shift signifies a sustainable and innovative approach to pharmaceutical packaging in harmony with environmental preservation.

Follistatin Protein Enhances Satellite Cell Counts in Reinnervated Muscle.

Background Muscle recovery following peripheral nerve repair is sup-optimal. Follistatin (FST), a potent muscle stimulant, enhances muscle size and satellite cell counts following reinnervation when administered as recombinant FST DNA via viral vectors. Local administration of recombinant FST protein, if effective, would be more clinically translatable but has yet to be investigated following muscle reinnervation. Objective The aim of this study is to assess the effect of direct delivery of recombinant FST protein on muscle recovery following muscle reinnervation. Materials and Methods In total, 72 Sprague-Dawley rats underwent temporary (3 or 6 months) denervation or sham denervation. After reinnervation, rats received FST protein (isoform FS-288) or sham treatment via a subcutaneous osmotic pump delivery system. Outcome measures included muscle force, muscle histomorphology, and FST protein quantification. Results Follistatin treatment resulted in smaller muscles after 3 months denervation ( p = 0.019) and reduced force after 3 months sham denervation ( p < 0.001). Conversely, after 6 months of denervation, FST treatment trended toward increased force output ( p = 0.066). Follistatin increased satellite cell counts after denervation ( p < 0.001) but reduced satellite cell counts after sham denervation ( p = 0.037). Conclusion Follistatin had mixed effects on muscle weight and force. Direct FST protein delivery enhanced satellite cell counts following reinnervation. The positive effect on the satellite cell population is intriguing and warrants further investigation.

Solid lipid nanocarriers as alternative drug delivery system for improved oral delivery of drugs

Oral bioavailability of drugs is mainly limited due to the poor aqueous solubility, enhanced chemical degradation, reduced permeation and/or first pass metabolism. Various novel delivery systems are developed for improved oral bioavailability of these drugs such as modified orals, buccal, transdermal and osmotic delivery systems. Colloidal carrier systems such as nanoparticles, lipid nanoparticles, nanoemulsions, microspheres, liposomes, resealed erythrocytes and transfersomes were also developed to enhance the oral delivery. Among these, solid lipid nanocarriers (SLNs) also gain much attention on the enhancement of oral bioavailability. SLNs are submicron sized nanoparticles and composed of solid lipid, surfactants and cosurfactants. The enhanced oral bioavailability of poorly soluble drugs from SLNs might be due to the reduced particle size, bypassed presystemic metabolism, and enhanced gastric mucosa permeability. Vast literature is available for the advantages, limitations, preparation methods, evaluation parameters and application of SLNs in different routes. This review mainly focused on list of drugs developed as SLNs and considered as an alternative approach to enhance the oral bioavailability based on pharmacokinetic as well as pharmacodyanmic parameters was discussed.&#x0D; Keywords: Oral bioavailability, solubility, first-pass metabolism, solid lipid nanoparticles, pharmacokinetics, pharmacodynamics.

Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology

PurposeTo determine if a validated Level A in-vitro in-vivo correlation (IVIVC) could be achieved with the extrudable core system (ECS) osmotic tablet platform. Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis. MethodsFast-, medium-, and slow-release modified-release formulations of 11 mg tofacitinib ECS tablets, and one formulation of 22 mg tofacitinib ECS tablet, were manufactured. In vitro dissolution of the tofacitinib ECS tablets was performed using USP Apparatus 2 (paddles) and in vivo pharmacokinetic (PK) data were obtained from a Phase 1 study in healthy volunteers. A 5 mg immediate-release formulation tablet was included to support deconvolution of the tofacitinib ECS PK tablet data to obtain the in vivo absorption profiles. A linear, piecewise correlation and a simple linear correlation were used to build and validate two IVIVC models. ResultsThe prediction errors (PEs) for the linear, piecewise correlation met the Food and Drug Administration's criteria for establishing a Level A IVIVC, with a maximum absolute individual internal PE of 4.6%, a maximum absolute average internal PE of 3.9%, and a maximum absolute external PE of 8.4% obtained. ConclusionsThis study demonstrates that the tofacitinib ECS osmotic tablet platform can achieve a Level A IVIVC, similar to other osmotic delivery systems.

Sustained and controlled release of herbal medicines: The concept of synchronized release

Synchronized release, defined as simultaneous release of multiple components while keeping the inter-component ratios steady, is crucial to the design and development of sustained- or controlled-release delivery systems of herbal medicines. A theory of infinite dose dividing is proposed to interpret the rationale behind synchronized release. The key point of the mechanisms is to curb diffusion so as to offset the release divergence caused by differences in physicochemical properties of multiple components. In practice, pH-dependent gradient-release, erosion-controlled and osmotic pump delivery systems have been adapted to attain synchronized release of model herbal medicines. Nevertheless, synchronized release is still in the proof-of-concept stages and should be corroborated by more evidence with more model herbal medicines.

Development, Evaluation and Optimization of Osmotic Controlled Tablets of Aceclofenac for Rheumatoid Arthritis Management

Objective: Rheumatoid arthritis is a dreaded disease, characterized by pain, inflammation and stiffness of joints, leading to severe immobility problems. The disease shows circadian variation and usually gets aggravated in early morning hours. Aceclofenac, a BCS Class II compound is routinely used in the treatment of pain and inflammation associated with rheumatoid arthritis. The objective of this study was to develop an osmotic delivery system of Aceclofenac that after administration at bedtime would deliver the drug in the morning hours. &lt;/P&gt;&lt;P&gt; Methods: A series of osmotically controlled systems of aceclofenac was developed by using lactose, sodium chloride and hydroxypropyl methylcellulose K100M as osmogens. Cellulose acetate (2% w/v in acetone) with varying concentrations of polyethylene glycol-400 was used as the coating polymer to create semi permeable membrane and dissolution was carried out in 290 mOsm phosphate buffer. Formulation optimization was done from four considerations: cumulative release at the end of 6 hours (lag time), cumulative release at the end of 7 hours (burst time), steady state release rate and completeness of drug release. &lt;/P&gt;&lt;P&gt; Results: A formulation having swelling polymer hydroxypropyl methylcellulose in the core and lactose and sodium chloride as osmogens, polyethylene glycol-400 (16.39 %) as pore former, with a coating weight of 5% was a close fit to the target release profile and was chosen as the optimum formulation. Conclusion: Aceclofenac tablets containing lactose, HPMC and sodium chloride in the core, given a coating of cellulose acetate and PEG-400 (5% wt gain), generated a release profile for optimum management of rheumatoid arthritic pain.

Characterization of crosslinked hard gelatin capsules for a structural assembly of elementary osmotic pump delivery system

The objective of this study was to characterize the crosslinked hard gelatin capsules (HGCs) for use as a structural assembly of elementary osmotic pumps (EOP). HGCs were crosslinked in formaldehyde vapor for 6, 12, and 24 h. Weight loss after immersing in various mediums, water soluble protein fraction, loss on drying, and formaldehyde residue were investigated. Fourier transform infrared (FTIR) spectra were used to detect the crosslinking formation. The EOP capsules were prepared for delivery of diltiazem hydrochloride (DIL HCl) and ambroxol hydrochloride (AMB HCl), which are freely and sparingly water soluble drugs, respectively. Physicochemical stability of storage crosslinked HGC shells was investigated. All crosslinked HGC shells were water insoluble. FTIR spectra exhibited intermediate lysine methylol and arginine methylol peaks. Storage time increased, moisture content increased and formaldehyde residue decreased. The developing EOP capsules were more appropriate for delivery of high water soluble rather than low water soluble drug. EOP capsule contained 100 mg DIL HCl using HGCs crosslinked for 12 h provided release profiles for 12 h with a lag time of 2.6–3.1 h. It was also found that DIL HCl EOP capsules prepared using crosslinked HGC shells stored for 90 days maintained the similar drug release profiles. AMB HCl EOP capsules exhibited low drug release. In summary, the crosslinked HGCs were applicable as a structural assembly of the osmotic controlled drug delivery system.

Decades of research in drug targeting using gastroretentive drug delivery systems for antihypertensive therapy

The limitations in absorption of drugs with narrow absorption window, or those unstable in the intestinal pH or those exhibiting low solubility at high pH are primary candidates for gastroretentive drug delivery systems (GRDDS). The delivery system has been widely explored for its commercial potential for a wide variety of therapeutic agents. GRDDS offer clinical therapeutics for acute and chronic management. Hypertension is a chronic disease that requires long term treatment and its management by patient compliant dosage forms would be clinically useful. Antihypertensives belonging to different classes have proved good candidates for the formulation of GRDDS. The review aims to discuss various GRDDS researched for antihypertensive drugs to increase the gastric residing time, bioavailability, henceforth to reduce the dose of the drug, dosing frequency and increase patient compliance. It also explores various marketed products and the patents filed/granted for GRRDS of antihypertensives. The GRDDS investigated include effervescent and non-effervescent floating drug delivery systems, swelling and expanding systems and bio/mucoadhesive systems. Many other systems that provided research platforms include high density systems, raft forming systems and osmotic delivery systems. In clinical context, wherein combination of antihypertensives is indicated, dual release delivery systems may also be explored.

СУЧАСНИЙ СТАН СТВОРЕННЯ, ВИРОБНИЦТВА ТА ДОСЛІДЖЕННЯ ТАБЛЕТОВАНИХ ЛІКАРСЬКИХ ПРЕПАРАТІВ Повідомлення 25. Осмотичні системи вивільнення та доставки лікарських речовин: характеристика імплантаційних мініосмотичних, оральних та спеціальних типів осмотичних систем, їх застосування

Проведено огляд літературних джерел щодо характеристик та можливостей застосування імплантаційних мініосмотичних, оральних та спеціальних типів осмотичних систем вивільнення та доставки лікарських речовин, наведено приклади осмотичних систем, які зареєстровані на світовому ринку.

0464 : Selenoprotein T gene therapy with adeno-associated virus-9 improves cardiac function/remodeling in rats with heart failure

Selenoprotein T (SelT) is a thioredoxin-like protein, which is abundantly but transiently expressed in the heart only during the embryonic development. Although SelT seems to play a limited role in adulthood, preliminary data from our laboratory showed that myocardial infarction increases SelT protein expression. This suggests that SelT may play a yet unrevealed role in cardiovascular diseases. Our studies have proven that SelT supplementation, using osmotic minipump delivery system, clearly improves cardiac remodeling and function, cardiac perfusion and decreases cardiac inflammation pathways after experimental heart failure (HF). Thus, we sought to investigate the cardiac effects of SelT over-expression by administration of recombinant adeno-associated virus 9 (rAAV9) in HF. Wistar rats received a single intravenous injection of either rAAV9-SelT or saline serum one week after coronary artery ligation and left ventricular function/remodeling was determined 3 months after ligation by echocardiography. rAAV9-SelT (1.1011 virus-genome copies) resulted in an increased cardiac SelT expression (+150%, p<0.05).This SelT over-expression reduced HF induced increase in left ventricular diastolic (sham: 6.14±0.16; HF: 10.83±0.36, p<0.05 vs. sham; HF+rAAV9-SelT: 9.92±0.21 mm, p<0.05 vs. HF) and systolic diameters (sham: 3.08±0.17; HF, 9.13±0.35, p<0.05 vs. sham; CAL+rAAV9-SelT: 8.14±0.27 mm, p<0.05 vs HF). Simultaneously, SelT improved stroke volume (sham: 0.49±0.02; HF: 0.41±0.01, p<0.07 vs. sham; CAL+rAAV9-SelT: 0.46±0.02 ml/beat, p<0.05 vs. HF) and cardiac output (sham: 173±7; HF: 153±6, p<0.05 vs. sham; CAL+rAAV9-SelT: 178±7 ml/min, p<0.05 vs. HF) without change in heart rate or body weight. Our results are the first to show that rAAV9-mediated-SelT gene therapy produces beneficial effects on cardiac remodeling and function in rats with HF. The author hereby declares no conflict of interest

Dyskinesia, cardiac arrhythmia and partial seizure associated with paliperidone overdose: a case report

Paliperidone is a new atypical antipsychotic agent. There are few literature reports of paliperidone overdoses and we report a case of these. A 32-year-old man was admitted to Emergency Department for occurrence of opisthotonus, muscular spasms and rigidity. Twenty hours before, he had an ingestion of 168 mg of paliperidone. He had hypotension and tachycardia. The dystonic reaction completely resolved within a few minutes after diazepam. Nine hours after admission, he sudden showed a right hemisoma partial seizure. The peculiar interest of our case is that three different and rare symptoms occurred in successive times after overdose. Some symptoms occurred after several hours following overdose. Oral paliperidone is available as an &lt;em&gt;osmotic release delivery system&lt;/em&gt; that results in a gradual rise in plasma concentrations. According to this limited experience in which delayed onset of toxicity has been observed, it may be prudent to recommend prolonged observation after overdose of paliperidone.

Randomized Trial of Continuous Subcutaneous Delivery of Exenatide by ITCA 650 Versus Twice-Daily Exenatide Injections in Metformin-Treated Type 2 Diabetes

OBJECTIVETo evaluate ITCA 650, a continuous subcutaneous miniature osmotic pump delivery system of exenatide versus twice-daily exenatide injections (Ex-BID) in subjects with type 2 diabetes.RESEARCH DESIGN AND METHODSWe conducted a randomized, two-stage, 24-week, open-label, phase 2 study in type 2 diabetes inadequately controlled with metformin. Stage I: 155 subjects were randomized to 20 or 40 μg/day of ITCA 650 or Ex-BID 5→10 μg. Stage II: 131 subjects were rerandomized to 20, 40, 60, or 80 μg/day of ITCA 650. Change from baseline for HbA1c, weight, and fasting plasma glucose were evaluated at weeks 12 and 24.RESULTSHbA1c was significantly lower in all groups after 12 and 24 weeks. Stage I: mean change in HbA1c from a mean baseline of 7.9–8.0% was −0.98, −0.95, and −0.72% for the 20 and 40 μg/day ITCA 650 and Ex-BID groups, respectively, with 63, 65, and 50% of subjects achieving HbA1c levels ≤7% (P < 0.05). Stage II: significant (P < 0.05) reductions in HbA1c (∼1.4% from baseline) were achieved with 60 and 80 μg/day ITCA 650, and 86 and 78% of subjects achieved HbA1c ≤7% at 24 weeks; respectively. Weight was reduced by 2.8–3.7 kg (P < 0.05) at 24 weeks in all except the 20→20 μg/day group. ITCA 650 was well tolerated; nausea was lower and transient with 20 μg/day relative to Ex-BID; and 60 μg/day had the best profile of tolerability and HbA1c lowering.CONCLUSIONSITCA 650 significantly reduced HbA1c and weight and was well tolerated. The 20→60 μg/day regimen was considered the best dose for further examination in phase 3.

Formulation and characterization of osmotic delivery of Levetiracetam

T present study deals with formulation and characterization of oral extended release elementary osmotic pump delivery system for the novel anti-epileptic drug-Levetiracetam. Levetiracetam is a highly water soluble drug over a wide range of pH 1 to 7.8. Therefore its release may be controlled by formulating it in the controlled release system like oral osmotic drug delivery. The present research work describes the controlled release osmotic delivery of levetiracetam. Here, core tablets were prepared after optimizing the type and amount of binder, the type and amount of osmogen and the type and amount of polymer. Binders like maize starch, PVP K-90, co-povidone-28 were used. Sodium chloride and mannitol were tried as osmogen while different grade of HPMC in different concentration were used to increase its dissolution possessing properties. Later on, the core tablets were coated with different types and amount of cellulose acetate. Further the coated tablets were drilled using laser drill. A 32 factorial design were applied by taking two variables – amount of osmogen and percentage weight gain of coat. The prepared tablets were evaluated for in vitro drug release and its mechanism of release. The optimized formula for oral elementary osmotic pump was found out and it was giving the desired drug release pattern for period of 12 hrs by zero order release mechanism.

Formulation development and evaluation of controlled porosity osmotic pump delivery system for oral delivery of atenolol

In the present study, we developed and evaluated the controlled porosity osmotic pump (CPOP) based drug deliverysystem of sparingly water soluble drug atenolol (ATL).We selected target release profile and optimized different variables to help us achieve this. Formulation variables, such as, the levels of solubility enhancer (0-15% w/w of drug), ratio of the drug to the osmogents, coat thickness of the semipermeable membrane (SPM) and level of pore former (0-20% w/w of polymer) were found to effect the drug release from the developed formulations. Cellulose acetate (CA 398-10) was used as the semipermeable membrane containing polyethylene glycol 400 as the Cplasticizer. ATL release was directly proportional to the level of the solubility enhancer, osmotic pressure generated by osmotic agent and level of pore former; however, was inversely proportional to the coat thickness of SPM. Drug release from developed formulations was independent of the pH and agitation intensities of release media. Burst strength of the exhausted shells decreased with increase in the level of pore former. The optimized formulations were subjected to stability studies as per International Conference on Harmonisation (ICH) guidelines, and formulations were found to be stable after 3 months study. Steady-state plasma levels of drug were predicted by the method of superposition.

Formulation development and evaluation of controlled porosity osmotic pump delivery system for oral delivery of atenolol

Formulation development and evaluation of controlled porosity osmotic pump delivery system for oral delivery of atenolol

Design and Development of Solid Self Emulsifying Osmotic Delivery System of Nifedipine

Design and Development of Solid Self Emulsifying Osmotic Delivery System of Nifedipine

Paliperidone ER: efficacia nella gestione in acuto e nel mantenimento per la schizofrenia?

Introduction Paliperidone, the major active metabolite of the atypical antipsychotic (AA) risperidone, is available in an oral extended-release (ER) formulation and is indicated for the acute and maintenance treatment of schizophrenia in adults. Materials and methods This article overviews the recommended dosing strategies for the treatment of schizophrenic patients in acute and chronic care settings. The efficacy, safety, pharmacology, pharmacokinetics, drug-drug interactions, and administration of paliperidone for schizophrenia are reviewed. Results Paliperidone's advanced-generation osmotic release delivery system makes it possible to avoid dosage adjustments when initiating therapy, and it may decrease the frequency of antidopaminergic effects that can occur with an immediate-release formulation. The recommended dose of paliperidone for the treatment of adults with schizophrenia is 6 mg every morning. Patients that receive daily doses ranging from 3 to 12 mg displayed generalized symptom improvement on the Positive and Negative Syndrome Scale (PANSS) and improved functioning on the Personal and Social Performance Scale. Discussion Paliperidone ER is a useful option in the treatment and prevention of the acute symptoms of schizophrenia. It may also be of use in patients with non-acute disease, including those previously treated unsuccessfully with other oral antipsychotics.

Therapeutically relevant blood pressure differences with two nifedipine (60 mg) osmotic delivery systems of differing design: three case reports

During the introduction of a new once-daily nifedipine 60 mg osmotic delivery tablet to Canada in 2009, several patients previously maintained at target blood pressure on regimens that included nifedipine 60 mg daily were observed to have > 10 mmHg rises in their systolic pressure during follow-up. The only difference noted in their medication and clinical status was a substitution with the new 60 mg nifedipine formulation by their pharmacists. Three patients agreed to report home blood pressure for N of 1 studies in which all clinical parameters remained the same, but their nifedipine was repeatedly switched between the original and alternate formulations each week. Of 14 recorded switches, systolic pressure was higher on the alternate formulation 13 times. In at least some patients, the alternate pump technology appears less effective. This highlights the need for better bioequivalence criteria for comparing differing delivery technologies that artificially retard absorption of the drug.

Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration

This study was designed to evaluate and compare the bioavailability of two osmotically active formulations of 60 mg nifedipine, Gen-Nifedipine extended release Test tablets (Genpharm ULC, Etobicoke, ON, Canada) and Adalat XL Reference tablets (Bayer Healthcare AG, Leverkusen, Germany) after single dose fasted and fed administration. The study was performed following a 4-period crossover design with both investigational products obtained from marketed batches. The complete pharmacokinetic evaluation was carried out in 26 healthy male subjects with a median age of 29.5 years (range 18 - 44 years), mean weight of 79.7 kg (range 66.0 - 97.5 kg), and a mean body mass index (BMI) of 24.1 kg/m(2) (range 22.1 - 26.9 kg/m(2)). Tablets were administered with tap water either under fasting conditions or immediately following a high-fat, high-calorie breakfast. Blood samples were taken predose and at pre-defined time points until 48 h post dosing. Samples were protected from light during handling and frozen until analysis. A validated LC-MS/MS method was used for the quantification of nifedipine in plasma samples. All kinetic parameters were determined model-independently for each treatment directly from measured concentrations. Monitoring of subject safety was accomplished by routine monitoring of blood pressure, heart rate and probing for adverse events. In-vitro dissolution curves show later onset and considerably lower quantity of nifedipine release from Test compared to Reference tablets. Under fasting conditions total and maximum exposure, represented by geometric mean AUC(0-tlast)- and C(max)-values, respectively were 466.7 h*ng/ml (AUC(0-tlast)) and 21.9 ng/ml (C(max)) for Test and 507.8 h*ng/ml (AUC(0-tlast)) and 22.0 ng/ml (C(max)) for Reference tablets. However, the Test product exhibited a notably longer lag-time and less rapid onset of absorption than the Reference tablets. Moreover, the plateau phase is maintained for about 14 hours on Test but for almost 20 hours on Reference. Point estimates (PE) and associated 90% confidence intervals (CI) were determined as 91.8% and 79.9 - 105.5% for AUC(0-tlast), as well as 99.8% and 88.6 - 112.4% for C(max). Larger differences were found for AUC(0-9h) (PE: 54.8%; CI: 45.8 - 65.5%) determined as parameter for early exposure. Under fed conditions, although the mean plasma concentration time curves look similar in shape, concentrations of Test compared to Reference tablets are considerably lower at all time points until 36 hours after dosing. Again the lag time in onset of drug absorption is notably longer for the Test product. Both, total and maximum exposure, represented by geometric mean values for AUC(0-tlast) and C(max), were considerably lower (differences also statistically significant) after administration of Test with 481.8 h*ng/ml for AUC(0-tlast) and 25.3 ng/ml for C(max) in comparison to Reference tablets with 595.9 h*ng/ml for AUC(0-tlast) and 31.9 ng/ml for C(max). Test/Reference point estimates (PE) and associated 90% confidence intervals (CI) were determined as 80.7% and 73.7 - 88.5% for AUC(0-tlast), as well as 79.6% and 70.3 - 90.0% for C(max). Differences were also even more expressed for AUC(0-9h) (PE: 54.9%; CI: 47.4 - 63.5%) determined as parameter for early exposure. The results indicate that although both products are osmotic release systems they are not bioequivalent according to the accepted standards. This difference between both osmotic delivery systems might be substantiated by the fact that the core of the Test product is designed as a monolayer system (containing both, the active ingredient and the osmotic component) while Reference tablets consist of two separate layers. The observed pharmacokinetic differences may have an impact on blood pressure control in patients and thus, should be kept in mind when switching during treatment.

Use of scoring to induce reproducible drug delivery from osmotic pulsatile tablets

An osmotic-controlled pulsatile delivery technology was developed for targeted drug delivery. This novel system consists of a tablet core surrounded by an osmotic coating that has been mechanically compromised in strategic locations to facilitate reliable drug release at a given time point after administration. The tablet core contains a high drug load in addition to several osmotic agents and swellable polymers, and the surrounding mechanically-compromised osmotic coating consists of a semipermeable membrane that has been scored with a razor blade in several key locations. The components in the tablet core attract water into the core, causing it to swell and propagate the scores in the coating along the length of the tablet. After the scores have fully propagated, the coating bursts open, releasing the tablet core’s contents, including the drug, into the surrounding media. The variables that were investigated in this study included the configuration of the scores in the coating, the length of the scores, and the distance between the scores. The delivery system developed in this work is able to generate a reproducible dissolution profile consisting of a specific targeted lag time, between five minutes and two hours, followed by immediate release of the drug from the core. The performance of the system was validated in vitro using the drug salicylic acid. Unlike previously developed osmotic pulsatile delivery systems, the present system is able to accommodate higher drug loading levels, it is easier to manufacture, and has demonstrated more reproducible burst times (i.e. burst time) than several other pulsatile systems.