In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate

Study Overview
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Brief Summary
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The relative bioavailability of different salbutamol sulphate inhaler formulations will be studied in healthy male subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (1996) after the approval of the ethical committee, Faculty of Pharmacy, The British University in Egypt.

Detailed Description
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In this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight: 65-80 kg) will carry out screening procedures which include instruction and practice with the placebo metered dose inhaler devices that will be used in the study. In addition, all subjects were fully informed in writing of the objectives and implications of the trial. No subject will be considered for the study if developed any symptoms of allergic disorders. Subjects will follow a normal diet and will not receive any other medications. Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae. Each volunteer will inhale eight puffs (4 puffs at -5 min & 4 puffs at 0 min) which are equivalent to 0.8 mg of salbutamol sulphate . To inhale through metered dose inhalers, volunteers will be trained to exhale slowly to their residual volume (as far as comfortable), put the inhaler into their mouth and seal their lips round the mouth piece. Then they will be instructed to take a slow deep inspiration to their total lung capacity over approximately 5-10 seconds. At the end of each inhalation, they will hold their breath for 10 seconds and then breathe normally (Ball et al, 2002) . Three milliliters of blood will be withdrawn at 0, 0.5, 1, 2, 3, 4, 5 and 6 h after administration. The blood will be heparinized immediately and centrifuged at 3000 rpm for 10 minutes. The plasma samples will be stored at freeze temperature until analysis. Two different formulae will be compared during the first six hours following administration. The maximum plasma concentration (Cmax), the time required to reach maximum plasma concentration (Tmax) and the area under plasma concentration time curve (AUC) will be calculated using validated Excel software.

Official Title
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Novel Nano-vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization, In Vitro and In Vivo Evaluation

Conditions
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Drug Effect, Pulmonary Disease

Intervention / Treatment
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* Drug: Salbutamol Sulphate
* Drug: Niosomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Exclusion Criteria: Chronic disease Smoking Hospitalization

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niosomal salbutamol sulphate inhalers<br>Niosomes | Drug: Niosomes<br>* Niosomes<br>* Other names: nano-vesicles;|
| Placebo Comparator: salbutamol sulphate inhalers<br>control testing | Drug: Salbutamol Sulphate<br>* salbutamol sulphate packaged as aerosol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum plasma concentration (Cmax) | The maximum concentration of Salbutamol Sulphate in human blood after time intervals 0, 30, 1,2, 3,4 , 5 & 6 hs will be calculated using validated using Excel software. | Twenty Four Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time required to reach maximum plasma (Tmax) | Time taken for Salbutamol Sulphate to reach its maximum concentration in human blood & will be calculated using validated using Excel software | Twenty Four Hours |