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    0676 nasal prep. EP+BP

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    28 views5 pages

    0676 Nasal Prep. EP+BP

    Uploaded by

    Mahmoud Abdelhakem mahmoud

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 5
    11-62 General Monographs ‘ concentration of atleast 45 per cent min The sweet taste ‘can also be obtained by using other polyols or sweetening ‘agents. Syrups usually contain aromatic or other favouring agents. Each dose ffom a multidose container is administered bby means ofa device suicable for measuring the preseribed volume, The device is usually a spoon ors cup {oe volumes of 5 mi. or maliples thereof LABELLING "The label states the name and concentration of the polyol ot sweetening agent POWDERS AND GRANULES FOR SYRUPS DEFINITION Powders and granules for syrups are inteaded to be reconstituted with che prescribed liquid t produce a liquid preparation Tor oral use. ‘They may contain excipients 10 Iliate dissolution. Alter dissoluion, they comply withthe requirement for syrups ‘TESTS Uniformity of dosage units Single-dose powders and granules for syrups comply with the test for uniformity of dosage units (2.9.40) of where justified and authorised, with the tests for uniformity of content and/or uniformity of mass shown below. Herbal drugs and herbal drug preparations present inthe dosage form are not subject tothe provisions of this paragraph Uniformity of content (2.9. ‘Unless otherwise prescribed dr usted and authorised, single-dose powders and granules for syrups with a content of active substance fess than 2 mg or less than 2 percent ofthe {otal mass comply with test B for uniformity of content of| single dose preparations. Ifthe preparation has more than ‘one active substance, the requirement applies only to those ‘substances that comespond ro the above conditions. Uniformity of mass (2.9.5, Single-dose powders and granules fr syrups comply with the test for uniformity of mas of single-dose preparations. Ifthe test for uniformity of content is presribed forall che acive substances, the test for uniformity of mass i not required. Oral Liquids of the British Pharmacopoeia In ein 1 te ave eure of he pian Pharmac, te oli sttenent apt any dit Fc, mor lemon tsb te a {nda monnroph he Brith Phorm DEFINITION Ona Liquids othe than Orat Emulsions may be supped s tiquids or prepared just before issue for use by dissolving or dispersing granules or powder in the liquid stated on the iter LABELLING “The abel ates for On Emulsions, Ol Suenos end there appropiate or Mares thatthe bone should be Thakon bere se IF the Ora Lig is sapped as granules or powder 0 be Consittd jut before ve fru the abel states thatthe 2022 contents ofthe container are granules or powder forthe preparation of an Oral Liquid ELDURS DEFINITION lis are clear, favoured Oral Liquids contining one or more active ingredients dissolved in a vehicle that usually contains a high proportion of Sucrose ora suitable polyhydre slechol or alcohols and may also contain Ethanol (96 percent) or a Dilute Ethanol LINCTUSES DEFINITION Linctases are viscous Oral Liquids that may contain one or more active ingrediens in solution. The vehicle usually ‘contains a high proportion of Sucrose, other sugus or @ suitable polyhyrc alcohol orsleohols.Lincrses are lovended for use in the teatment or relief of cough, and ate sipped and swallowed slowly without te addon of water. MIXTURES DEFINITION ‘Mixtures are Oral Liquids containing one or more active ingredient dissolved, suspended or dispersed ina suitable ‘hile. Suspended solids may separate slowly on standing but are eulyredispersed on shaking, ‘ORAL EMULSIONS DEFINITION (rat Emulsions are Oral Liquids consining one ot more active ingredients. They ae stabilised ol-in-vater dispersion, either or both phases of which may contain slssolved solids, Solids may ato be suspended in Oral Emulsions. ‘When issued for use, Oral Emulsions should be supplied in wide-mouthed bottes. [Extemporoneous preparation In Oral Emulsions prepared according tothe formula and dliceeons given for Extemporaneous preparation, the quancgy of emubifying agent spciid in individual ‘monographs may be reduced 10 yield a preparation of suitable consistency provided that by to dong the stably of the preparation is not adverscly affected, Nasal Preparations (Ph, Bae, monogroph 0676) DEFINITION [Nasal preparations are preparations intended for ‘administration to the nasal cavities to deliver active substances for a local or systemic effect. They are liquid, ‘emivsolid or solid prepartions containing one ot moce sctive substances in a suitable vehicle. They may contain excipients, for example to adjust the tonicity o viscosity of the preparation, to adjust or sable the pH, to inerease the solubility of the active substances, to stable the preparation (oF wo provide adequate antimicrobial properties. The excipients do not adversely affect the intended medicinal worw.webofpharma.com 2022 action ofthe preparation or, at the concentrations used, ‘cause toxicity or undve loca irtation. [Neral preparations are supplied ia mukidose or single-dose containers, if necessary provided witha suitable ‘administration device that is designed to avoid the Jiteducton of contamina Unless ciherwise justified and authorised, aqueous nasal preparations supplied in multidose containers conta a suitable presevaive ata suitable concentration, except where the preparation isl has adequate antimicrobial properties. Preparations for administration to the injured nose, particularly when the mucosa is damaged, or prior to surgery are sterile and, unless otherwise justified and authorised, fee {rom preservatives and supplied in single-dose contsiners. ‘Where applicable containers for nusl preparations comply Containers (3:1 and subsection) and Gontinn (2.2 and subeections. Sreral categories of masa preparations may be dniubed: — nasal ops — nesal sprays = sal powders — semisolid neal preparations, nasal washes, mal Ss PRODUCTION ang the development of masa preparations whose formulation contains a preseativ, the need fr abd the eficacy of the chosen preservative shal be demonstrated to the nsfiction ofthe competent auhoriy. A sable text rmethod together with eter or adging the preservative ‘ropes ofthe foemulaon are provided in general chapter S13. Bficay of antimicrobial presereation. Jn the manufacture, peckaging storage and dsuibuon of ual propoaons, suitable meavues ae taken o ease {he meri quabys recommendations on this aspect are provided in gene chapce 51.4. Minobilgeal qua of ow sterie plarmacasialpreprain and subuanc for Phamacaal e- Serle nasal preparations are prepared using materials and methods designed to easrestenity and to avoid the introduction of contaminant andthe growth of miro- organisms eecommenvations on this aspect ae provided general copter 5-1. Methods of proparaton of tle probs In dhe manaficac of nasal preparations containing doperst particles, measures ae taken to ensue a suitsble and controled parle size with regard to the intended use During manufacture of metered-dose nasal prays and smetere-lse nasal powders supplied in mulidore Containers, the uniformity af delivered dose must be ensured ihn a comainer (aua-conuine) and bewecn containers (overcontains). For inua-conine testing of the usifomnity of delivered dog, att gen in the Tes secon For inte-continertesig ofthe unifomiy of delivered doe, se blow. Uniformity of delivered dose, inter-container testing nes others jutied and suhore, the est applic Propare and wth containers a diced their the pati. ‘An example of suitable procedure i to take 10 cootiness and ellec a single dose from each container, collecting the ore athe besaning (Bom 3 contsinen), middle (Eom General Monographs III-63 4 containers) and end (Geom 3 containers) ofthe number of ses stated on the label, Other intr-containe resting procedures are possible, where jusied A sultable dose collection apparatus i descbed in the monograph Preparations for inhalation (0671). ‘Tests Sterility 2.6.0 ‘Where the label states thatthe preparation is sei it complies with the test STORAGE If the preparation is sterile store in a sterile, airtight, tamper- evident contine. LABELLING The label sate: the name of any added preservative; = where applicable, chac the preparation is sterile for mulidese containers ~ the petiod within which the preparation is to be used her openings — where applicable, the number of deliveries pee — where applicable, the delivered dose of ifustiied and authorised (eg. where the dose has been established ssa metered dose or as a presmetered dose), the metered dose or the pre-metered dose NASAL DROPS DEFINITION [Nasal drops ate liquid preparations intended for insiltion into the nasal cavities, They are solutions, emulsions or suspension NNesal drops that are emulsions may show evidence of phase separation but are readily redispersed on shaking. Nasal ‘drops that are suspensions may show a sediment that i readily dispersed on shaking to give a suspension that ‘emai sufficiently stable to enable the corect dose to be delivered [Nasal drops ace usually supplied in mulidose containers of fase ora suitable plastic material chat are fied with an Incogal dropper ot with a screw cap of suitable materials Incorporating « dropper and rubber or plastic teat, This cap Assembly may also be supplied seperately. PRODUCTION ‘During the development of nasal drops supplied in sngle- dose container, it matt be demonstrated thatthe nomial content can be withdravm from the container. ‘Tests ‘Unless otherwise prescribed or justified and authorised, nasal

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