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    Running Head: DRUG DELIVERY SYSTEM 1

    DEVELOPMENT AND CHARACTERIZATION OF A CONTROLLED-RELEASE

    CIPROFLOXACIN HYDROCHLORIDE DRUG DELIVERY SYSTEM

    Samar Z. Al-sa!!a1

    1Department of pharmaceutical Sciences, College of Pharmacy, Princess

    NourahBintAbdulrahman University, Alriyadh, Saudia Arabia

    Aiman A. "#aida$%&

    Department of Pharmaceutical !echnology, "aculty of Pharmacy, #ordan University of Science

    and !echnology, $rbid, #ordan,

    Alsa'ed A. Sallam(&

    %Speciali&ed Pharmaceutical 'esearch Company, Amman, #ordan

    Mu$a) S. Salem*

    +,rresnding Au$r/s 0ame

    +2ne 0um#er

    +Email Address

    Keywords

    ,n$rlled drug deli3er' s's$em& ,ir4l5a6in H'dr6lride& 7an$an gum& ,ar#l 8(*2&

    2r'lene gl'6l& Gel-4rming s's$ems.

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    DRUG DELIVERY SYSTEM %

    A!STRACT

    Co"#e$#,ir4l5a6in H'dr6lride 9,7-H,l; is an an$i#i$i6 used $ $rea$ #a6$erial

    in4e6$ins in man' di44eren$ ar$s 4 $e #d'. I$ des n$ !r< 4r 3iral in4e6$ins 94r e5amle&

    $e 6mmn 6ld E44e6$i3eness 4 ,7-H,l and a$ien$ 6mlian6e 6uld #e enan6ed $rug

    drug deli3er' s's$em en6uraging leng$' drug release and $ere4re imr3ing i$s usage

    in$er3als.

    O%&e'#()eT u$line de3elmen$ and 6ara6$eri)a$in 4 a 6n$rlled-release 6ir4l5a6in

    'dr6lride drug deli3er' s's$em. Te aim 4 drug deli3er' s's$em is $ gi3e 6ir4l5a6in

    'dr6lride 9,7-H,l; in 6n$rlled release !a'.

    Me#*odsTe s$ud' as #een !r

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    DRUG DELIVERY SYSTEM *

    salad dressings& 4r e5amle; and a s$a#ili)er 9in 6sme$i6 rdu6$s& 4r e5amle& $ re3en$

    ingredien$s 4rm seara$ing;.

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    DRUG DELIVERY SYSTEM B

    INTRODUCTION

    ,ir4l5a6in H'dr6lride 9,7-H,l; als

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    DRUG DELIVERY SYSTEM F

    $i6al and r s's$emi6 dsage 4rms1. 7an$an gum 97G; is a l'sa66aride

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    DRUG DELIVERY SYSTEM

    LITERATURE SURVEY

    Man' resear6ers re3ie!ed 6ir4l5a6in 4rm #i-degrada#le 6msed 4 $ri-6al6ium

    sa$e 9T.,.2;& 6al6ium sa$es 'dr5'aa$i$ie 9H.A.2; and $ri-6al6ium sa$e

    9T.,.2;& 6ir4l5a6in 9,..7;& and (

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    DRUG DELIVERY SYSTEM

    imlan$s 4r #ne in4e6$ins/ l6al $rea$men$& as ma>ri$' 4 $e s's$ems 4 drug deli3er' release

    an$i#i$i6 4r 3er' less $ime and e5$ended in$ra3enus an$i-mi6r#ial $rea$men$ 94r a$ leas$ 4ur

    $ si5 !ee

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    DRUG DELIVERY SYSTEM 8

    MATERIALS AND METHOD

    M/#er(/,s

    ,ir4l5a6in H'dr6lride 9,7-H,l; and ,ir4l5a6in =ase 9,7-#ase; !ere US2

    grades and !ere gi4$ samles 4rm $e Ara# 2arma6eu$i6al Manu4a6$uring ,. L$d.& 9A2M;

    9Alsal$& ?rdan;.7an$an Gum 97G;& ,ar#l-8(* 9,-8(*;& Eudragi$ RL 1& and E$'l

    ,ellulse !ere 4 arma6eu$i6al grade and !ere gi4$ samles 4rm $e Ara# 2arma6eu$i6al

    Manu4a6$uring ,. L$d.& 9A2M; 9Alsal$& ?rdan;.Trie$'l ,i$ra$e US20& Di#u$'l 2$ala$e

    US20& and 2l5amer * and !ere gi4$ samles 4rm $e Ara# 2arma6eu$i6al

    Manu4a6$uring ,. L$d.& 9A2M; 9Alsal$& ?rdan;.H'dr6lri6 a6id 9H,l;& (K& reagen$ grade& n-

    "6$'l al6l& reagen$ grade& A@uagen$ 6msi$e B& 4ree 4rm 'ridine& ne 6mnen$ re-agen$

    4r 3lume$ri6 Jarl-is6er $i$ra$in& Sdium 6lride& e5$ra ure& 2Eur& US2& =2& 2$assium

    =rmide& IR& Se6$rs6' grade& A6e$ni$rile& is6ra$i6 H2L, grade 9%B* nm;& A6e$i6 A6id

    gla6ial& H2L, grade. All $e re3ius reagen$s !ere ur6ased 4rm Sarlau& Sain. 2r'lene

    Gl'6l 92G;& Sdium a6e$a$e $ri'dra$& Me$anl& is6ra$i6 H2L, grade 9%B* nm;& Sarlau&

    Sain. a$er 4r H2L,& A6rs. Tigl'6la$e medium #ase 9enri6ed; a66. T ,D, 4r

    mi6r#ilg'& Mer6

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    DRUG DELIVERY SYSTEM 1

    @.s. $ B ml $ rdu6e a slu$in 6n$aining 7G .B er6en$ !!: ,-8(* .B er6en$ !!:

    ,7-H,l .B er6en$ !! 9SD1;& r $ rdu6e an$er slu$in 6n$aining 7G .B er6en$ !!:

    ,-8(* .B er6en$ !!: ,7-H,l .Ber6en$ !!: 2G .B er6en$ !! 9SD%;.

    Te slu$in !as sra' dried !i$ =U,HI 18 mini-sra' dr'er& S!i$)erland. i$ $e

    4ll!ing 6ndi$ins: 2um# 9(-*mlmin;& Tem. 9Inle$ Tem. 1 N % ,& u$le$ Tem. F N

    %degree 6en$igrade;& Asira$r 9*;& air 4l! 6n$rl 9BB;.

    F/%r('/#(o" o. Powders .or Dr+7 De,()ery Sys#e9s /"d O'+,/r I"ser#s

    Te sra' dried !der SD% !as mi5ed !i$ sui$a#le amun$s 4 $e 4ree drug ,7-H,l

    $ rdu6e di44eren$ ra$is 4 drug $ ma$ri5 9sra' dried rdu6$; !ders and $ rdu6e

    di44eren$ $a#le$ 4rmulas& as s!n in T/%,e :. SD% !ders !ere 6sen 4r 4a#ri6a$in 4 $e

    drug deli3er' s's$ems and n$ SD. Ta$ is #e6ause SD1 !ders s!ed signi4i6an$ redu6$in in

    drug 6n$en$ #' gamma s$erili)a$in !ile SD% didn/$. Te nminal ,7-H,l dse in $e

    medi6a$ed inser$s !as 6sen $ #e F.%B mg. ,mnen$s 4 !der 4 ea6 4rmula !ere mi5ed

    $rugl' in small 3ials !i$ a sa$ula 4r % minu$es #e4re 6mressin& $en 6mressing $e

    !der mi5$ures !i$ $e el 4 'drauli6 ress in 4la$-4a6ed $a#le$s 4 B millime$er diame$er&

    #' ali6a$in 4 $usand Jg 4r6e 4r B se6nds.

    Ta#le$s !ere $en 4ilm 6a$ed !i$ Eudragi$ RL 1 9RL; l'mer slu$in 9RL 1K

    dissl3ed in is-rranll FK: a6e$ne *K sl3en$ s's$em& di#u$'l $ala$e 1K !! 4

    RL !eig$& and $rie$'l 6i$ra$e %K !! 4 RL !eig$; #' diing $e $a#le$s in $e l'mer

    slu$in $en rem3ing and la6ing i$ n $e Te4ln la'er and le$ i$ dr' 4r .B ur a$ *,.

    Diing again in l'mer slu$in and la6ing i$ n Te4ln sur4a6e n $e $er $a#le$ 4a6e& and

    le$ i$ dr' 4r .B ur a$ * ,. Ta#le$s/ $i6

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    DRUG DELIVERY SYSTEM 11

    In $is s$ud'& $e $e6ni@ues $a$ u$ili)ed in 6ara6$eri)a$in 4 $e riginal drug alne as

    !ell as $e reared sra' dried !ders& !ere 7-ra' di44ra6$me$r' 97RD; using 7-Ra'

    Di44ra6$me$er: 2 1%8& 2ilis& Hland& s6anning ele6$rn mi6rs6e 9SEM;EI 92ilis;&

    Ouan$a %& Hland& di44eren$ial s6anning 6alrime$r' 9D.S.,; Simad)u Di44eren$ial S6anning

    ,alrime$er D.S.,-B 6nne6$ed !i$ I=M ersnal s's$em& ?aan& $erm gra3ime$ri6 anal'sis

    9TGA; Simad)u Term gra3ime$ri6 Anal')er TGA-B 6nne6$ed !i$ I=M ersnal s's$em&

    ?aan& and 4urier $rans4rm in4rared se6$rs6' 9TIR;Ma$$sn In4ini$' GldTMTIR

    Se6$rs6'& ,de 0. RD(1R0I& USA. A3erage re radius& $$al re 3lume& e5$ernal

    sur4a6e area and se6i4i6 sur4a6e area 4 $e sra' dried s's$em !ders SD1 and SD% !ere

    iden$i4ied u$ili)ing $e Mul$iS$a$in Hig Seed Gas Sr$in Anal')er: 0"VA %% 3. F.11&

    Ouan$a6rme ,.& USA. Te $rue densi$' 4 $e sra' dried s's$em !ders !as de$ermined

    using Helium 2'6nme$er: Ul$ra'6nme$er 1 3. %.%& Oua$a6rme ,.& USA.

    Mi6r#ilgi6al Sus6e$i#ili$' Tes$ S$udies

    Te release 4 ,7-H,l 4rm $e drug deli3er' s's$ems !as in3es$iga$ed #a6$erilgi6all'

    as seen in igure 1 in agar la$es seeded !i$ Staphylococcus aureus%B8%B 9S( aureus;& and

    Pseudomonas aeruginosa%B( 9P( aeruginosa; as $e $es$ mi6rrganisms.

    Using Mueller Hin$n Agarla$es. S$erili)e $e 6u #' immersing i$ in e$anl $en 4laming&

    and la6ing i$ n $e la$e& $en u$$ing $e samle r s$andard in $e 6u& ei$er in susensin

    4rms 4 sra' dried !der in dis$illed !a$er r as !der. ,3er $e e$ri dis. 2u$ in

    in6u#a$r 9( N .B

    ,; 4r %* urs r mre. Ini#i$in )nes/ diame$ers !ere assessed arund

    $e 4rmula$ins. S$udies !ere 6arried u$ in $rili6a$es.

    S#er(,(;/#(o"

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    DRUG DELIVERY SYSTEM 1%

    Sra' dried !ders 9S.D1 and S.D%; and 4ilm 6a$ed 6ular inser$s 94 1 4rmula; !ere

    s$erili)ed !i$ $e el 4 gamma radia$in. Te sra' dried !ders !ere gi3en an 3erall dse

    4 1 M Rad 9mega rads;& % M rad& and ( M rad. Tese $ree samles 4 $e !der& ea6 ne

    !ere e5sed $ di44eren$ dses 4 gamma radia$in& ea6 samle 4 $ree runs. Te 1 4ilm

    6a$ed 6ular inser$s !ere gi3en a $$al amun$ 4 1 M Rad. Tis !as dne a$ $e ?rdan A$mi6

    Energ' ,mmissin& Amman& ?rdan. Sra' dried ma$ri5 s's$ems !ere assessed 4r 6n$en$

    e5amine& in 3i$r release r4ile& and 4r 6lr. S$erili)ed 6ular inser$s !ere e3en assessed 4r

    in$a6$ness and 6lr 4 6ular inser$s& as !ell as 4r $eir in 3i$r release r4ile $ 6e6< gamma

    radia$in/s in4luen6e n $ese 6ara6$eris$i6s. A s$erili$' $es$ n s$erili)ed 6ular inser$s !as

    6arried u$ as men$ined #' US2 using $igl'6la$e susensin. Te $es$ !as 4 4a#ri6a$ed

    6ular inser$s and !as dne $ 6e6< !e$er $e' !ere s$erile r n$ a4$er $e' !ere s$erili)ed

    !i$ gamma radia$in.

    S#/%(,(#y S#+d(es

    S$a#ili$' resear6es !ere er4rmed n sra' dried !ders 9SD1 and SD%;. Su44i6ien$

    amun$s 4 sra' dried !ders 9e6$ed $ e5aggera$ed

    6ndi$ins 4 $emera$ure& umidi$'& and lig$ 4r a66elera$ed s$a#ili$' s$ud'. 9( ,& * ,& B

    ,& F ,& *,PBKRH& and $ s$a#ili$' in Am#er #$$les and in ,lrless e$ri dises;

    Samles !ere !i$-dra!n a$ di44eren$ $ime #rea

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    DRUG DELIVERY SYSTEM 1(

    remaining drug 3ersus $ime in da's& !ere $e sle is e@ual $ -J%.(( and J is C$e

    degrada$in ra$e 6ns$an$.

    Dr+7 Co"#e"# (" S6r/y Dr(ed Prod+'#s1 mg !der !as sa

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    DRUG DELIVERY SYSTEM 1*

    ml samle a$ di44eren$ $ime in$er3als u $ %F urs and rela6ing i$ !i$ B millime$er 4

    dis