الفهرس 
Literature of revieOnly 14 pages are availabe for public view
 |  | from | 186 |  |  |
| | | from | 186 | | |
Abstract
The Present Thesis Is Generally Divided Into Two Parts :
Part 1: In-Vitro Study To Investigate The Variables That May Affect The Total Emitted Dose Of Salbutamol Dry Powder Including The Rate Of Inhalation Flow, Inhalation Volume And Number Of Inhalations.
Part 2: In-Vivo Study To Evaluate Relative Lung Deposition And Systemic Bioavailability Of Inhaled Salbutamol from Aerolizer.
Salbutamol Is A Potent Short Acting Β2-Agonist Which Is Recommended For The Management Of COPD By The GOLD Guideline To Be Administered As Needed To Relieve Symptoms. Nowadays, Measurement Of Pulmonary Drug Deposition Has Gained A Great Importance In The Contex Of Drug Development .
In The In-Vitro Part, Salbutamol In Ventolin Diskus, Which Is A Multi-Dose Plastic Inhaler Device With A Medium Resistance Containing A Foil Strip With 60 Regularly Spaced Blisters Of 200µg Salbutamol, Was Emptied And Placed In Size 3 Capsule Suitable For Use With Aerolizer . Total Emitted Dose (TED) Delivered By Aerolizer Was Determined After One And Two Inhalations from The Same Dose Using 10-60L/Min Inhalation Flows At 2 And 4L Inhalation Volume.
The Highest TED Was At Inhalation Flow 40L/Min Above Which The Effect Of The Second Inhalation Was Negligible. At Inhalation Flow ≤30L/Min, Two Inhalations Resulted In Significant Higher TED Than One Inhalation. No Significant Difference Was Found Between Inhalation Volume 2L Or 4L.
In The In-Vivo Part , 12 chronic Obstructive Pulmonary Disease (COPD) Patients And 12 Healthy Volunteers Were Participated In The Study. The In-Vivo Study Was A Prospective, Four-Way, Open-Label Trial With Cross Over Design. The Healthy Subjects And The COPD Patients Participated In The Study For Seven Days In Which They Received Four Study Doses Of 200μg Salbutamol (One Inhalation Slow Flow, Two Inhalations Slow Flow, One Inhalation Fast Flow, Two Inhalations Fast Flow) In Four Alternative Days With 24 Hours Washout Period After Each Dose. Two Urine Samples Were Collected from Each Study Subjects, The First Was Provided 30 Min Post Inhalation (USAL0.5) And The Second Was Pooled To 24 Hr Post Inhalation (USAL24). The Amount Of Salbutamol In Each Sample Was Then Determined.
Fast Inhalation Resulted In Significantly Higher USAL0.5 And USAL24 Than Slow Inhalation After One Inhalation In Both Healthy Subjects And COPD Patients But There Was No Significant Difference Between Slow And Fast Inhalation After Two Inhalations. One Inhalation Resulted In Significant Higher USAL0.5 And USAL24 In Healthy Subjects Compared To COPD Patient At Both Slow And Fast Inhalations. Also, Two Inhalations Resulted In Significant Higher USAL0.5 And USAL24 In Healthy Subjects Compared To COPD Patients At Slow Inhalation Only.