Pharmaceutical oral Suspension

Pharmaceutical oral suspension

1. Dosage lab Assignment : “ Oral suspension ” Group members : ✓ Muhammad Owais Khan (R-61)_______19-2019. ✓ Muhammad Ahmer Khan (R-050)____116-2019. ✓ HASAN AZMI (R-54)__________________95-2019. ✓ ARRAZ AHMED (R-16)________________73-2019. ✓ SADIA SHEIKH ( R-101)______________ 280-2019. CMS –ID :

2.  ViDeo on Suspension :

3.  Introduction --- Oral suspension : SUSPENSION : A heterogeneous mixture that contains a fine(undissolved) particles in a liquid phase.The suspension refers to a 2-phase system consist of insoluble solid particles(Senpensoid or disperse phase) dispersed or suspended in liquid(disperse medium).They are intended for oral,topical, parental administration. TOPICAL SUSPENSION : Topical suspensions are liquid preparatios intended for application to the skin.Topical administration means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams,lotions, and ointments. Eg.Calamine Lotion PARENTAL SUSPENSION : Parenteral suspensions are dispersed, heterogeneous systems containing insoluble drug particles suspended in either aqueous or vegetable oil vehicles.Parenteral preparations are sterile containing one or more active ingredients intended for administration by injection, infusion or implantation into the body.. Eg.Procaine Penicillin G.

4.  Oral suspension : ORAL SUSPENSION : Suspension administrate orally are oral suspension.A suspension mixture contains two or more API(Active Pharmaceutical Ingredients).The particles first float then settle down to bottom upon standing and size is too large about 1000nm that can be seen through naked eye.
The suspension particles not passed through the filter paper and easily separated.It has advantage on other dosage forms as some insoluble drugs administrate easily .It helps patients who can’t swallow tables and capsules and disperse unstable insoluble drugs easily. About 5 ml volume of dosage form is adminsistrate. The large particles suspended in the bulk shows TYNDALL effect (scattering the light by large size particles).

5.  Aggregation & FLOCCULATION & Sedimentation : AGGREGATION : ‘The dispersed particles comes together not fuse but to make compact bodies aggregate.” FLOCCULATION : A process of making loose compact of particles (charged ones) that clumps or make Floccules dispersed in a liquid medium. This phenomena balance by attractive and repulsive forces between particles.The particles are called “floccules.” SEDIMENTATION : ‘ Sedimentation means settling of particles or floccules to bottom under gravitational force in liquid dosage form.’ The sedimentation depends upon particles size,shape,density,viscosity of vehicle and several others factors and can be estimated by STOCKES EQUATION. => [ V = D(p1-p2)g /18 n°]

6.  RATE OF SEDIMENTATION : V= Viscosity of disperse medium, g= acceleration due to gravity, D= diameter of suspended particles, n° =viscosity of external medium, p1= density of disperse phase, p2= density of disperse medium, V= velocity of sedimentation rate. An ideal sedimentation should exhibit high viscosity at a negligible shear rate and low viscosity at high shear rate.Sedimentation is the downward movement of particles under gravity that cause particles to Sediment. Reducing particles size and increasing (viscosity ,temperature) reduces Sedimentation Two factors needs to be considered the Speed of Sedimentation and Reversibility. A slow Sedimentation rate of defloccules is more desirable ,However Reversibility of floccules system is better. The Solubility profile of drug needs to be established.The particles must be suspended initially and remains throughout out its shelf life.

7.  Viscosity effect on Sedimentation : VISCOSITY EFFECT ON SEDIMENTATION : To prevent sedimentation ingredients that increases viscosity added.The co-relation between viscosity and Sedimentation indicates that greater viscosity leads to lower sedimentation rate. “ Higher viscosity results in lower sedimentation efficacy.” Although reducing particles size or increasing viscosity and density of disperse medium can retard the sedimentation rate.

8.  FLOCCULATED / Deflocculated Suspensions : FLOCCULATED SUSPENSIONS : When the particles are loosly aggregate with high or rapid sedimentation rate.The floccules behaves as large,porous individuals and will begin sediment quickly,leaving behind a clear supernatant.
A Pharmaceutical suspension that redispersed/resuspend on only mild agitation to ensure dosage uniform sizes.The disperse phase form a network growth of particles.
In Flocculated ones particles settle quickly than Deflocculated ones relatively to their particles sizes.
Flocculation can be control by by balancing attractive and repulsive forces between dispersed particles in dispersion medium.This suspension is mainly use in making medicament because they are easily redispersed after shaking/agitation.

9.  Deflocculated Suspension : Deflocculated Suspension : When the particles are disperse as discrete(separte)entities called Deflocculated Suspension. The sedimentation rate is low and sediment form is dense,compact and packed particles starts a undesirable phenomena of caking. This Deflocculated Suspension are almost impossible to resuspend/redispersed even with vigorous shaking. But this can be minimize by using suspending or viscosity modifiers.

10.  FLOCCULATED /DEFLOCCULATED SUSPENSION VERBAL VIDEO DESCRIPTION :

11.  Role of formulation aids in preparation of suspension : The success of dosage form largely depends on formulation parameters and factors that influence the bioavailability of active medicaments and therapeutic effect of dosage forms.Because excipients have potential to affect particulate interaction,sedimentation rate.Therefore the effects of additives needs to be studied. VISCOSITY : Practically speaking,the viscosity of dispersion medium is the only variable to affect sedimentation rate over which pharmacist can exert control.Pharmacists used suspending and thickening agents to thicken the suspension medium thereby reducing particles movement.This is important in flocculated system in which particles rapidly settle down.Hence, controlling the primary factor by adding such agents help to maintain uniformity in product. The system should be redispersed upon mild shaking easily. Agents included: Acacia,Tragacanth,Locust,Gelatin, Carboxy Methycellulose and Sodium Carboxy Methycellulose.(includes stabilizing, suspended and viscosity modifiers).

12.  Thixotropy,Electrolytes Effects And other Additives : The ( Thixotropy) property of Vehicle(solvent) also play important role because shear thining property of certain viscous dosage forms become thinner overtime when shear-stresss or agitation is applied on dosage form. ELECTROLYTES : Electrolytes acts by reducing zeta potential which brings the particles together to form loosely arranged mass.The FLOCCULATED particles power increases with the valency of ions upon presistent addition of electrolytes.The electrical barrier between particles reduces approach to reach at each other thus flocculation becomes zero and sedimentation increases sharply. Most drugs are prepared containing antibiotics , colorants , flavorants like( grape fruit taste ), Sweeteners( Sucrose, Saccharin ) , preservatives ( ascorbic Acid,parabens ), chemical stabilizer such as antioxidants(Sod ium carboxymethyl cellulose (CMC), Sodium metabisulfite ),surfactants,suspended or viscosity modifiers must be added.But at last Floccules modifiers to adjust the status of particles and designated amount of pure water 💦.

13.  Advantages and disadvantages of oral suspension : ADVANTAGES : DISADVANTAGES : 1_Some insoluble drugs are given orally.So,the drugs in Suspension are more stable than in Solutions.Suspensions have high rate of bioavailability. 1_Particles Brownian motion during transportation effect the interparticulate distance and interaction between particles. 2_The particular importance is of administration to children and geriatric patients. 2_The particles Unstability leads to lack of Uniformity of dosage form. 3__The disagreeble tasted-drugs can be adminsistrate after taste masking by a Suspension products. 3_Oral Suspension products easily sediment at the bottom of container on long standing. Caking process starts. 4_Oral Suspension products administrate to patients having swallowing problems especially infants,elderly patients. 4_Products can be degrade by hydrolysis, oxidation and by microbial activity.

14.  RHEOLOGICAL CONSIDERATION : RHEOLOGICAL CONSIDERATION: The Rheological system must be pseudo plastic and should have high viscosity at low shear rate and low viscosity at high shear rate during shaking or pouring.The flow property of rheology suspension must be characterized and manipulate to ensure optimal performance of dosage form.The Rheological property depends upon solid content and shear rate applied.However,a well mixed suspension vary by conc.distribution of ingredients in formulation.The shape,size and rheological behaviour of suspension has control on mixing maerial and it matter flows. ORAL SUSPENSIONS : Drugs with activities like antacid, antibacterial, antibiotics, analgesic, antifungal, anticonvulsant could be formulated as ORAL –Suspension. The oral products should have a dosing volume of 5ml. Eg- Azithromycin,Niacin,Ofloxacin dispersed as pediatric suspension.

15.  Product be-like : PRODUCT Be-LIKE: Products must be tightly packed in air tight container,light resistant container by PHARMACISTS .
The suspension particles should settle down slowly and redispersed on shaking ,particles size should remain fairly constant in shelf life of dosage form. Important specifications for the manufacture include assay and microbial limits,particle size of the suspended drug, viscosity, pH, and in some cases dissolution. Products must masking the bitter taste(Chloramphenical Palmitate) Resistant to degradation by hydrolysis, oxidation and microbial activity.

16.  DISPENSING BE-LIKE & Instructions on labels : DISPENSING Be –LIKE: Some suspension are ready to use while others are prepared solid materials mixture containing sweeting, flavouring, suspended agents and active medicaments and so on intended for constitution just require the use of appropriate vehicles to dispersed them at the time of dispensing. For Pediatric patients or Geriatic ones may be placed into infants mouth or mixed with portion of food. Dose-limit relates to age must be given with how many times dose need to administrate in a day. The patient should be instructed to shake prior to use and observe any color change that indicates stability problems. Instructed to “Keep out of the reach of children”.

17.  Continue …… Do not keep outdated medicine.Exipry and manufacture date with Approval of FDA. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.Instructed to protect the products from moisture, freezing or excessive heat or change in temperature because this lead to aggregate formation in dosage form. (Reconstitution date + 14 days)of reconstituted suspension is stable for no more than 14 days.Consult your pharmacist or local waste disposal company.But since it’s mixed with water, it’ll expire after 14 days lost it potency and uniformity. QUALITY CONTROL TESTS INCLUDES : Apperance,color, odour,taste,Sedimentation rate,Zeta potential, Reversibility,Rheological,Stress,pH Tests needs to be done.

18. √ Labels: INSTRUCTIONS ARE MENTIONED ON LABEL OF PRODUCTS :

19.  CONTRIBUTION : Muhammad Owais ( Introduction-to-Suspension and Oral Suspension ) Muhammad Ahmer ( Definitions and Rate of Sedimentation & Effect on Viscosity on it )
Arraz Ahmed ( Flocculated & Deflocculated Suspensions and Excipients aid in Formulation )
Hasan Azmi ( Advantages /Disvantages and Rheological Consideration ). Sadia Sheikh ( Product be-like / Dispensing be-like and Instructions on Label. )

20. Reference : https://pharmlabs.unc.edu/ Books Ansel Pharmaceutical Dosage Forms -Drugs Delivery System. Aulton Pharmaceutics. Pharmaceutical Compounding and Dispensing. CONCLUSION : Verbal discription by ARRAZ AHMED. Thank you !