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Medchem and packaging Flashcards

1
Q

What is the skin anatomy?

A

Epidermins: Thin sheet outer layer
Dermis: collagen + elastic tissue + reticular fibers
Subcutaneous tissue

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2
Q

What is the route of drug penetrate the skin?

A

Surface: drug dissolves + diffuses + releases from vehicle

Partition/diffusion - all the way to the systemic circulation

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3
Q

What are the different type of bases for hydrophobic ointments?

A

Hydrocarbon bases:
Hard paraffin BP + Yellow and white soft paraffin BP
Immiscible with water and low water absorbing capactiy
Form an occlusive barrier - hydrate and encourage absorption
Not prone to oxidation
Parafffin can be sterilised by dry heat - i.e. eye ointment and many antibiotics
Messy and stain clothing
Absorption base:
absorb water
Water in oil emulsions i.e. lanolin alcohols
less occlusive - increaseing water absorptive power

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4
Q

What is ideal properties of a drug for rectal delivery?

A

Good solubility and lipophilicity + substantialy unionised at pH 7.5
Slower absorption rate - lower peak plasma conc
Lipophillic durgs best formulated in a hydrophillic suppository base and

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5
Q

What are the advantages of using glass as a packaging material?

A 
Clear
Strong
Stable + heat resistance
Impermeable
Resistant to acid
Canb e treated to modify the surfaces
Hygienic 
Sterilisable
Economic
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6
Q

What are the disadvantages of using glass as a packaging material?

A 
Not maleable or ductile
Breakable
Difficult to work
Attached by alkali
Sensitive to mechanical handling
Heavy
Limited range of colours
Transparent to visible light + some UV
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7
Q

What are the properties of glass?

A

super cooled liquid
Prmary constituesnt of silica and mineral quartz
Pure silica forms glass when heated
Silicon dioxide polymerise with strong covalent bonds - matrix
Great tensile strength
Fragile and not ductile
Thermal resistant - high softening point (1600dec)
Transparaent to visible and some UV
Very resistant to acid but attached by alkali - forms soluble sodium silicates at pH >8

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8
Q

Why is soda (sodium carbonate) added to the glass?

A

reduces softening point of glass to approx 600 dec

Soda alone reduces chemical resistance - susceptible to degradation

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9
Q

Why is lime added to glass?

A

Replace some of the sodium ions with calcium and closing up the matrix in the glass
Hence improves chemical resistance
Soda lime glass - sodium ions in the matrix can diffuse out of the glas into aqueous solutions - leaching
Problem for alkali sensitive compounds i.e. alkaloids
Microfractures and separation of flakes of glass
Sodium salts can cause flaking i.e. sodium chloride, bicarbonate, citrate, lactate and gluconate

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10
Q

What are the Pharmacopoeial glass types?

A

PhEur/USP Type I: Neutral glass (Borosilicate) - parenteral use
PhEur/USP Type II: Soda lime Silica glass - Aq parenteral use where pH is lower than 7 (Surface treated: sulphated or silicon coated)
PhEur/USP Type III: Soda lime Silica - Aq oral, not for parenteral
USP-NP: Soda lime silica - low hydrolytic resistance - non-aq solids for oral use

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11
Q

Special considerations in glass bottles manufacturing.

A

Glass formation and quality in the furnace
Lubricants for parison graphite based - burned off in Lehr
Quality of tools
Spray outside of bottles “conveyor” lubricants - contamination inside?
Temperature control
Final handling of containers - clean when come out from Lehr

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12
Q

What is vulcanisation?

A

General term involves compounding of rubber with a variety of additives i.e. curing agent and compressing it in metal moulds at elevated temp
Invovles corss-linking between polyisoprene chains
Improves heat stability of the rubber and its resistance to organic solvents

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13
Q

What are the disadvantages of natural rubber?

A 
High permeability to gas and water
Ages rapidly/cracking of surface
Poor thermal stability
Susceptible to microbial attack
Leaches additives - form haze in stored solutions
Sorbs some compounds i.e. preservatives
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14
Q

What are the main types of rubber?

A

Natural Rubber
Tapping the tree Hevea brasiliensis
Highly elastic at room temp
Soluble in a variety of organic solvents
Soft plastic rubers formed by vulcanisation
Synthetic Rubber
Generally more resistant to chemcia nd less permeale to air/water
less inclided to leach
Poor elastic properties
i.e. butyl, halobutul and silicone rubbers

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15
Q

What are the typical ingredients of a rubber formulation?

A

Elastomer i.e. natural rubber + Rutyl Rubber + EPDM
Curing agent/vulcanising agent: i.e. Sulpur + organic peroxide + high energy radiation (cross link)
Accelerators i.e. complex organic compounds (control curing process)
Activators: i.e. ZnO + Stearic Acid (Activate the accelerator)
Plasticisers i.e. Di-octyl Phthalate + LMW polythene (soften the rubber)
Protecting agents i.e. Waxes + Phenolic compounds (prevent ageing)
Colorants i.e. Inert materials - FeO2 + TiO2 + carbon black
Extender/fillers i.e. Oils + china clay (obtain corect physical properties

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16
Q

What are the typical pharmacopoeial testing for closures?

A 
There are 12 typical tests:
Appearance/characters
Acidity/alkalinity or pH Change
Absorbance
Reducing substances
Extractable heavy metals
Extractable zinc
Ammonium
Residue on evaporation
Volatile sulphides
Penetrability
Fragmentation
Self sealing test
dimension i.e. min dia internal seal of stopper vs max neck dia of bottle
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17
Q

What are the typical pharmacopoeial testing for glass?

A

See Ph Eur: 3.2.1. Glass containers for pharmaceutical use
Type I & II: test A; hydrolytic resistance of the inner surfaces of glass containers
(surface test)

Type I glass containers (to distinguish from type II and type III glass containers) Test B (glass grains test) or test C (etching test)

Type I and type II glass containers where it is necessary to determine whether the high hydrolytic resistance is due to the chemical composition or to the surface treatment Tests A and B, or tests A and C

test B. hydrolytic resistance of glass grains (glass grains test)

test C. to determine whether the containers have been surface-treated (etching test)

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18
Q

What are the major types of plastics?

A

Thermosets
i.e. bakelite
Freq used for caps and other items - not in direct contact
produced by a condensation reaction
Thermoplastics
consists of linear polymers - addition polymerisation of identical compounds
Do not cross link but aggregates with VDW bonds

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19
Q

What are the main types of polyethylene plastics?

A

High, medium and low density

Most verstile and useful of all plastics i.e. films, closures and containers

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20
Q

What are the advantages of polyethylene?

A

Free from additives, impermeable to water, resistance to chem and solvents, translucent and flexible
Increase in density decrease felxibility but increase barrier properties and more heat resistant

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21
Q

What are the disadvantages of polyethylene?

A

LDP: substantial permeability to atmospheric gases i.e O2
permeability to essential oils - cause swelling
Permeability of organic solvents - labels !!
Tendancy to sorb certain compoudns i.e. preservatives
Liable to stress cracking

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22
Q

What are the advantages of Polypropylene?

A

Similar to polyethylene
Tertiary carbon - 0.05% antioxidant prevent degradation during MFG
Lightest plastic
Softens at 150deg c - autoclave
better physical strenght than LDP
less inclined to stress cracking and sorption of preservatives
Translucency and permeability to water and atm gases - slightly worse than HDP

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23
Q

What are the properties of Polyvinyl Chloride (PVC)?

A

UPVC - blister packs and plasticised grades - infusion bags
Good clearity and chmical resistance
High permeability to water vapour
Low metling point - need stabiliser
Poosible leaching of additives i.e. DEHP
More chemically resistant than polyethylene and equivalent sorption
Rigid PVC is less permeabler to gasses than HDP
Plasticised PVC siomilar to polypropylene

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24
Q

What are the disadvantages of PVC?

A

Much more permeable to water vapour
dissolved by some organic solvents i.e. acetone
poor native thermal stability - soften at 80 dec
stabilisers can increase heat resistance
Leaching hazard posed by the presence of DEHP - extracted by lipophilic materials - blood and alcohol

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25
What is PTFE?
Polychlorotrifluoroethylene (Alcar) Better barrier prorperties than PVC - more expensive Blister packs for moisture sensitive products
26
What is PET?
Polyethylene Terephthalate high tensile sterngth Commonly used in soft drinks industry for carbonated drinks Recyclable Resistant to dilute acids, alkalis and oils/solvents
27
What are the common additives used in plastics MFG?
Antioxidants - phenolic compounds (BHT)- leaching Heat Stabilisers: metallic stearates (PVC) Lubricants: internal and external - Zn Stearates and silicones Plasticisers: reduce brittleness - extractables Fillers: reduce flexibility - improve resistance + heat stability Colourants: dyes bleed out - pigments do not
28
What are the purposes of adding additives to plastics?
``` 7 reasons Assist processing Modify bulk mechanical properties Reduce formulation costs Modify surface properties Modify optical properties Improve ageing ```
29
What are the properties of aluminum as a packaging material?
impermeable to light, liquids, water vapour, gases does not support bacterial growth can be sterilised all widley used methods 25 micron - below this thickness - pin holes
30
What are the risk control measures in a packaging line?
``` Avoidance of composite gang printing Adequate control of printing media Celarance of previous work, set up, or extraneous materials from the line Use of code reading devices Avoidance of Splices ```
31
Pressurised Metered Dose Inhalers
Micronised powder suspended in propellant Pulmonary secretion are pH 7.4 Surfactants used in the formulation (oleic aicd or lecithin) Design of platic mouthpiece/valve are very important - correct droplet size and velocity
32
MDI filling
Orginal CFC - now HFA (Hydrofluoroalkane) EU GMP Annex 10 EM at filling: Class D + propellant filtered 0.2micron Check weight (100%) Cleanliness of valves, cans Care needed for leak testing - water bath method not used - store and check weigh
33
Summary of Annex 8: sampling of starting materials
Packaging materials: Quantity received Quality requried Nature of the material Production method - knowledge of supplier Knowledge fo the QA system of the packaging material supplier based on audit Number of samples - stats + sampling plan Sampling environment: Specifications: appropriately authorised +dated Description + Direction for sampling and testing + Qualitative and quantitative req/limit + Storage conditions and precautions + Max period of storage Testing: Visual appearance + ID/purity + Biologcial tests + Physical/dimention + proof/copy checking+colour Testing record: kept 2 years 2003.94.EC Status label
34
Why do we carry out stability testing?
``` Evaluate: Content of active Purity: impurites and degradation Organoleptic properties Physico-chem properties Micro status ```
35
What are the considerations of toxic degradation products?
``` Clinical use Max daily dose Duration of treatment Age group Women of child bearing potential Adverse effect from the degradation product? ```
36
What are the different types of stability testing?
3 main types: Stress testing: force degradation to take place Accelerated testing: incerase the rate of chem degradation or physical change of a drug substance - exaggerated storage condition Long term: cover expected duration of the shelf life and retest period
37
What are the requirements on stability testing on drug products in terms of batch size?
3 representative batches 2 batches pilot scale - 1 may be smaller Oral pilot: min 10% or 100k units Drug substances: 3 batches where possible 12 month long term + 6 month accelerated at the time of submission
38
Storage condition for stability testing
Long term: 25 deg / 60 RH or 30 deg / 65 RH | Accelerated: 40 deg / 75 RH
39
How would you extraolate shelf life based on data?
Little/no change at accelerated + long term: x 2, max 12/12 Some change/variability: with stats analysis (x2, max 12/12); no stats (x1.5, Max 6/12) Significant change at accelerated only: wikth stats (x1.5. Max 6/12); no stats (3/12) Significant change at accelerated and long term: no extrapolation
40
What are the requirements of post approval stability commitment based on ICH guidance?
Commitment batches: MFG batches for which the stability studies are initiated or completed post approval through a commitment made in the reg application Looking for 3 batches on long term and 6 months accelerated
41
What are the differences in matrix and bracketing?
Matrixing: design of a stability schedule - rotate through time points Bracketing: rotate through strengths/pack size
42
What are the main changes to labelling as a result of 2004.27.EC?
Introduction of article 56a: Braille format and PIL for blinded and partially sighted Amend Art 59: new order of PIL to bring in line with SPC Further amend Art 59 require consultation with target patient groups - user testing
43
What are the standard labelling requirements and where would you find it?
Art 54 2001.83.EC 14 requirements 1. Name + strength + form (Braille) 2. Qualitative and quantitative statement of the API per dose unit 3. Pharmaceutical form and contents by wt, volume or number of doses 4. List of excipients known to have a recognised effect (all excipients for injectables, topical or ocular preparations) 5. Method and route of adminstration 6. Keep out of reach and sight of children 7. Any special warning reuqired by the authorisation 8. Expiry date (mm+yy) 9. Storage conditions 10. Any special precautions for disposal of unused product or waste materials 11. Name and address of the MA holder and where applicable his representative 12. MA number 13. Batch number 14. Where the product is non-prescritpoin - instruction for use
44
What are the labelling requirement for blister packs?
1. Name + strength + form 2. Expiry date 3. Name of MAH 4. Batch number
45
What are the labelling requirement of small immediate packaging units?
1. Name + strength + form 2. Contents by wt, vol or unit 3. Method of administration 4. Expiry date 5. Batch number
46
What are the additional labelling requirement in the UK?
GSL Paracetamol and aspirin: Do not give to children undre 16 P: Warning do not exceed the stated dose Ephidrine: Asthmatics consult doctor before taking Antihistamine: warning may cause drawsiness + avoid alc drink Embrocation - for external use only Hexachlorophane: not to be used for babies
47
What is format of a PIL?
1. ID of the medicinal product 2. Tx indications 3. List of info before taking: CI + Precautions + interaction + special warnings 4. Instruction for proper use: dosage + route + Freq of admin + treatment duration + OD Tx + miss dose + withdrawal + constult pharm/doc 5. Description of ADR 6. Ref to the expiry date: 7. Where the medicinal product is authorised 8. Date of revision
48
What are the Annex 13 label requirements?
1. Name + add + tel no. of sponsor/CRO/PI (main contact) 2. Pharmaceutical form + route of admin + quantity of dosage units + strength/potency 3. BN / code 4. Trial ref code - id trail, site, investigaotr and sponsor 5. Trial subject ID or number 6. Name of the investigator 7. Direction of use 8. For clinical trial use only 9. Storage conditions 10. Period of use / expiry 11. Keep out of reach of children
49
What are the GMP considerations in a packaging operation?
Premises: Avoid mix up or cross contamination storage - allow orderly stroage of all materials Special attention to be paid to printed materials ? Straight line, dedicated room Separate exposed product from the paper cartons etc Product protection: creams/ointment/sterile/low bioburden Segregation: physical barriers + risk based approach (scheduling and campaign working) Product: Label asap Protect product where needed i.e. creams, liquids, and ointment Pack design to aid detection of mixups Use item and version codes Coding system: Pharmacode + Dot matrix + OCR + OCV Chp 5: check code reader is working Hand packing: Use edge codes + check new reel for splices for reel feed labels, leaflets and foils + rigorous reconciliation limits Process: Treat printed materials the same as RM Start up checks: Area clean and clear Line clearance Intermediate and bulk products kept under appropriate conditions Critical process validated display name and batch number check on delivery - printed materials IPC: General appearance of the packages Whether the packages are complete Whether the correct products and packaging materials are used whether any over-printing is correct correct functioning of line monitors Sample taken away from the packaging line should not be returned Other process specific checks: integrity + torque + blister seal checks
50
What are the likely physiological effects of injecting particles IV?
Less than 3 micron: phagocytosed More than 12 micron: trapped mechanically Blockage of lung capillaries: stimulate inflammatory response + granulomata Thrombophlebilits Sepsis
51
What are the pharmacopoeial requirement for inspection?
Ephur: practically free - visual inspection 100% visual inspection of all injections Visual standard = practically free white&black background and lighting 5s against white background and 5s against black background Sub vis: t be 100% inspected: test manually
52
What are the four areas considered In a Machine and System Risk Analysis?
Ethical or GMP risk: Risk of recall Market/business risk: Cosmetic defects and throughput of machine Operational Risk: Functional testing of the machine Safety or H&S risk: Risk to operator Ethical risks - validated 100%
53
What are the main risks involved in artwork gerenation?
``` Font management - bleed out font Multiple approaval cycles & amend loops Client brief (component collation and validation) Version control Compliance with MA + variation Conversion error: between versions and software i.e. word to Quark or illustrator Cut & paste errors from base file Software compatibility Multilingual packs Proof reader validation Space allowance: truth copy vs artwork Braille application Potential ISO 9001 conflict Reliance on Text Verification Tool and other text check tools Printing plates Pharmaspecific requirement Technical agreemtns Text errors Font size and line weights Untrained personnel ```
54
How would you validate a packaging line?
Power services: confirm requirement Compressed air + vacuum: confirm quality Environment: achived EM conditions? Cleaning: Materials of construction + Contact parts with drug + Ease of changeovers + dust traps + product traps Chagne parts: Available + Compatible + meet spec Overload, mechanical device jam: meet spec Automated sys: PLC / MMI interface GAMP (meet spec + effective control + simulate power on/off + critical instrument + control/security in action) Equipment interfaces: interface with other machines Limit detectors, pressure detectors, level detetors: confirm critical instrument fitted, correct operation Missing or damaged components and product detection
55
What are the common cleaning validation limits?
10ppm 1/1000 therapeutical dose visual clean
56
How would you devise a cleaning validation matrix?
``` Evaluate overall cleaning requirements Select worst case Toxicity Acceptance limits Physical characteristics - solubility Usage: high usage needs more often cleaing Concentration of active Previous resutls, difficulties in meeting limit ```
57
What are the QC tests of pacakaging materials?
Contact: Base materials: (PVC + PVDC + PE + Trilaminates) Description + ID by IR +thickness + width CoA pots/bottles/lits: Description + ID + embossing + outer dia + external height + CoA Bags: Description + ID + CoA Contact and printed materials Foil: Description + thickness + width + IR of heat seal lacquer + visual comparison of printed text + pentone colour ref + CoA Printed materials Labels/leaftlets/label leaflets/cartons: Description + visual comparison + Pantone Ref + CoA
58
What are the automatic monitoring system in use on a packaging line?
Missing tablets detectors: B/W system: Detect missing tab and missing fragments of >6% + 100% inspect + only see plan of tablet Colour system: Same as B/W + can tell different colour tablets Electronic tablet counter: Count tablets put in container + IR beam Pharmacode Readers: Code each component (foil + cartons + leaflets + labels + label leaflets) + made up of think thin bars (decimal code) + enter code at start All pharmacodes are challenged periodically during the packing run Printers/Print detection: online printing Embossing: added to the blister with metal type tool + check orientation + pressure Thermal/laser jet coders using dot matrix Blob detector: look for presence of ink in a certain location OCR: check correct coding applied + with laser coder Missing label detector - slat lines: looks for label Checkweigher: reject lightest component i.e. leaflet + challenge at intervals
59
List typical IPCs on a typical packaging line
``` Bulk product appearance and id Bulk product BN Quantity per container (auto) PVC/PVDC Foil ref Foil critical text Coding infomration on blister Challenge foil pharmacode (auto) Challenge missign tab detector (auto) Leaflet ref code Leaflet crtical text Challenge leaflet pharmacode (auto) Remove leaflet - challenge checkweigher (auto) Carton ref no Carton critical text Coding info on carton Challenge carton pharmacode (auto) High stack (too many blisters) (auto) Low stack (too few blisters) (auto) Quanitty per shrinkwrap Palletiser layout Record any engineering activties Ref any QERs ```
60
How would you carry out a line clearance procedure?
Finish packing operation - first operator line is free from product and packaging materials Second operator perform second check If rogue product / component found - photo and annotated

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